A Phase III, Randomized, Multi-country Study to Evaluate the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response, Safety and Reactogenicity of RSV Maternal Vaccine When Co-administered With GSK's Quadrivalent Influenza D-QIV Vaccine in Healthy Non-pregnant Women 18-49 Years of Age.
ClinicalTrials.gov processed this data on September 12, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED - HAS RESULTS(See Contacts and Locations)
Verified September 2023 by GlaxoSmithKline
Sponsor
GlaxoSmithKlineInformation Provided by (Responsible Party)
GlaxoSmithKlineClinicaltrials.gov Identifier
NCT05045144Other Study ID Numbers: 214709
First Submitted: September 6, 2021
First Posted: September 16, 2021
Results First Posted: October 5, 2023
Last Update Posted: October 5, 2023
Last Verified: September 2023
History of Changes
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Tracking Information | |
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First Submitted Date | September 6, 2021 |
First Posted Date | September 16, 2021 |
Results First Submitted Date | June 2, 2023 |
Results First Posted Date | October 5, 2023 |
Last Update Posted Date | October 5, 2023 |
Study Start Date | October 26, 2021 |
Actual Primary Completion Date | June 6, 2022 |
Current Primary Outcome Measures(submitted: September 12, 2023) |
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Change History | Complete list of historical versions of study NCT05045144 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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Brief Title | A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women. |
Official Title | A Phase III, Randomized, Multi-country Study to Evaluate the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response, Safety and Reactogenicity of RSV Maternal Vaccine When Co-administered With GSK's Quadrivalent Influenza D-QIV Vaccine in Healthy Non-pregnant Women 18-49 Years of Age. |
Brief Summary | The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: RandomizedInterventional Model: Parallel AssignmentMasking: QuadruplePrimary Purpose: Prevention |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
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Intervention | Combination Product: RSVPreF3(120 μg) A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group. |
Study Groups/Cohorts | Experimental: RSV lot1 GroupParticipants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. Intervention:
Experimental: RSV lot2 GroupParticipants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. Intervention:
Experimental: RSV lot3 GroupParticipants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care. Intervention:
Experimental: RSV+Flu pooled GroupParticipants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines. Intervention:
Active Comparator: Flu+Placebo GroupParticipants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group. Intervention:
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Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
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Recruitment Status | Completed |
Actual Enrollment(submitted: September 12, 2023) | 1586 |
Actual Study Completion Date | June 6, 2022 |
Actual Primary Study Completion Date | June 6, 2022 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Sexes Eligible for Study: Female |
Ages | 18 Years to 49 Years (Adult) |
Accepts Healthy Volunteers | Yes |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Finland, Finland, Finland, Finland, Finland, Finland, Finland, Finland, Finland, Korea, Republic of, Korea, Republic of, Korea, Republic of, Spain, Spain, Spain, Spain, Spain, Spain, Spain, Spain |
Administrative Information | |
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NCT Number | NCT05045144 |
Other Study ID Numbers | 214709 |
Has Data Monitoring Committee | No |
U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No |
IPD Sharing Statement | Plan to Share IPD: Yes |
Responsible Party | GlaxoSmithKline, GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | |
PRS Account | GlaxoSmithKline |
Verification Date | September 2023 |