Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified May 2025 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT03765073
Other Study ID Numbers:
C1091002
First Submitted
December 3, 2018
First Posted
December 4, 2018
Results First Posted
March 3, 2025
Last Update Posted
August 4, 2025
Last Verified
May 2025

ClinicalTrials.gov processed this data on July 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Group B Streptococcus Infections
Biological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: Multivalent Group B streptococcus vaccineBiological: PlaceboBiological: PlaceboBiological: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1208 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingDouble
Primary PurposePrevention
Official TitleA PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
Study Start DateJanuary 13, 2019
Actual Primary Completion DateMarch 3, 2024
Actual Study Completion DateMarch 3, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Stage 1 - Highest dose formulation a
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 1 - Highest dose formulation b
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Lowest dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Lowest dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Middle dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Middle dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Highest dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Highest dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 3 - Selected dose and formulation
Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 1 Placebo
Saline control
Biological: Placebo
Saline control
Stage 2 Placebo
Saline control
Biological: Placebo
Saline control
Stage 3 Placebo
Saline control
Biological: Placebo
Saline control

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
    Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
  2. Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1
    Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
  3. Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
    Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
  4. Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1
    Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
  5. Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
  6. Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
  7. Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
  8. Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
  9. Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
  10. Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
  11. Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2
    Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.
  12. Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2
    Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (\> 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
  13. Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3
    Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (\> 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
  14. Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2
    Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
  15. Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3
    Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
  16. Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
  17. Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
  18. Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
  19. Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
  20. Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
  21. Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
  22. Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
    Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
  23. Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
    Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
  24. Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2
    Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
  25. Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3
    Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
  26. Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2
    Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.
  27. Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2
    APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.
  28. Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2
    APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.
  29. Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2
    The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
  30. Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2
    Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
  31. Number of Participants With Vital Status: Infant Participants Stage 2
    Participants according to vital status as: live or neonatal death were reported in this outcome measure.
  32. Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3
    Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.
  33. Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3
    APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.
  34. APGAR Score at 5 Minutes: Infant Participants Stage 3
    APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.
  35. Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3
    The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
  36. Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3
    Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
  37. Number of Participants With Vital Status: Infant Participants Stage 3
    Participants according to vital status as: live or neonatal death were reported in this outcome measure.
  38. Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
  39. Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
  40. Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
  41. Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
  42. Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
  43. Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
  44. Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
  45. Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3
    An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Secondary Outcome Measures
  1. Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  2. GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  3. GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  4. GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  5. GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
    OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
  6. GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
    OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
  7. GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  8. GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  9. GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
  10. GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Eligibility Criteria

Ages Eligible for Study(Child, Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Inclusion Criteria Stage 1 Nonpregnant Women:
Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Negative urine pregnancy test at Visit 1 (prior to vaccination).
Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 1 Booster Vaccination:
Participant must have received investigational product at Visit 1.
Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
Negative urine pregnancy test at Visit 6 (prior to vaccination).
Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 2 and 3 Maternal Participants:
Healthy females \>=18 and \<=40 years of age who are \>=27 0/7 (Stage 2) or \>=24 0/7 (Stage 3) to \<=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening. Inclusion Criteria Stage 2 and 3 Infant Participants: Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.
Exclusion Criteria
Inclusion Criteria Stage 1 Nonpregnant Women:
Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Negative urine pregnancy test at Visit 1 (prior to vaccination).
Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 1 Booster Vaccination:
Participant must have received investigational product at Visit 1.
Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
Negative urine pregnancy test at Visit 6 (prior to vaccination).
Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 2 and 3 Maternal Participants:
Healthy females \>=18 and \<=40 years of age who are \>=27 0/7 (Stage 2) or \>=24 0/7 (Stage 3) to \<=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening. Inclusion Criteria Stage 2 and 3 Infant Participants: Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures. Exclusion Criteria Stage 1 Nonpregnant Women:
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
History of microbiologically proven invasive disease caused by GBS (S agalactiae).
Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw). Exclusion criteria Stage 2 and 3 Maternal Participants:
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
History of microbiologically proven invasive disease caused by GBS (S agalactiae).
Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).
Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.
Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response. Exclusion criteria Stage 2 and 3 Infant Participants: Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Contacts and Locations

Sponsors and CollaboratorsPfizer
Locations
Velocity Clinical Research | Mobile Alabama, United States, 36608Velocity Clinical Research, Phoenix | Phoenix Arizona, United States, 85006Chemidox Clinical Trials Inc. | Lancaster California, United States, 93534Chemidox Clinical Trials Inc | Lancaster California, United States, 93534Emerson Clinical Research Institute | Washington D.C. District of Columbia, United States, 20009Clinical Research Prime | Idaho Falls Idaho, United States, 83404Clinical Research Prime Rexburg | Rexburg Idaho, United States, 83440Lakeview Regional Medical Center | Covington Louisiana, United States, 70433MedPharmics | Covington Louisiana, United States, 70433St. Tammany Parish Hospital | Covington Louisiana, United States, 70433North Oaks Medical Center | Hammond Louisiana, United States, 70403North Oaks Obstetrics & Gynecology | Hammond Louisiana, United States, 70403Velocity Clinical Research | Slidell Louisiana, United States, 70458Boeson Research | Missoula Montana, United States, 59804Community Hospital | Missoula Montana, United States, 59804The Birth Center | Missoula Montana, United States, 59804Meridian Clinical Research | Hastings Nebraska, United States, 68901Frontier Pediatric Care (Follow-Up Visits for Infant Participants) | Lincoln Nebraska, United States, 68506Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams) | Lincoln Nebraska, United States, 68510Be Well Clinical Studies | Lincoln Nebraska, United States, 68516Lowcountry Women's Specialists | Summerville South Carolina, United States, 29485Summerville Medical Center | Summerville South Carolina, United States, 29485Coastal Pediatric Research | Summerville South Carolina, United States, 29486Sentara Leigh Hospital | Norfolk Virginia, United States, 23502The Group for Women | Norfolk Virginia, United States, 23502Tidewater Physicians for Women | Norfolk Virginia, United States, 23502Wits Reproductive Health and HIV Institute | Johannesburg Gauteng, South Africa, 2001Respiratory and Meningeal Pathogens Research Unit (RMPRU) | Soweto Gauteng, South Africa, 1862Charlotte Maxeke Johannesburg Academic Hospital | Parktown Johannesburg, Gauteng, South Africa, 2196Empilweni Services and Research Unit (ESRU) | Coronationville Johannesburg, South Africa, 2093Khayelitsha District Hospital (KDH) | Khayelitsha Western Cape, South Africa, 7784Michael Mapongwana Community Health Centre | Khayelitsha Western Cape, South Africa, 7784Site B | Khayelitsha Western Cape, South Africa, 7784FAMCRU | Parow Valley Western Cape, South Africa, 7505St George's University Hospitals NHS Foundation Trust | London Tooting, United Kingdom, SW17 0QT
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full Text)
Documents provided by PfizerStudy Protocol  March 27, 2023Documents provided by PfizerStatistical Analysis Plan  February 1, 2023