A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age

ClinicalTrials.gov processed this data on April 25, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified April 2024 by GlaxoSmithKline

Sponsor

GlaxoSmithKline

Information Provided by (Responsible Party)

GlaxoSmithKline

Clinicaltrials.gov Identifier

NCT05590403
Other Study ID Numbers: 219238
First Submitted: October 18, 2022
First Posted: October 21, 2022
Results First Posted: May 21, 2024
Last Update Posted: May 21, 2024
Last Verified: April 2024
History of Changes

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Study TypeInterventional
Study DesignAllocation: Randomized; Interventional Model: Parallel Assignment; Masking: Quadruple; Primary Purpose: Prevention
Condition(s)
  • Respiratory Syncytial Virus Infections
Intervention(s)
  • Biological: RSVPreF3 OA investigational vaccine
  • Drug: Placebo
Enrollment1544

Participant Flow

Recruitment DetailsOut of 1544 participants enrolled in this study, 1534 participants received at least one study intervention, from which 1 participant in OA-RSV group received placebo instead of RSVPreF3 OA vaccine and was excluded from the group. Therefore, the Exposed set included 1533 participants.
Pre-assignment DetailsThe results for this study were reported until Day 31 for immunogenicity analysis and up to Month 6 for safety analyses, since this is a primary completion posting. Data for final analysis will be updated at the time of End of Study (Final posting).
Arm/Group TitleAdults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
Overall Study
STARTED383192386191381
COMPLETED380191384190381
NOT COMPLETED3121Array
Lost to Follow-up3Array2ArrayArray
Consent withdrawal, not due to a (S)AEArray1Array1Array

Baseline Characteristics

Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV GroupTotal
Overall Number of Baseline Participants3831923861913811533
Age, Continuous | Measure Type: Mean | Unit of measure: YEARS
Number Analyzed383 years192 years386 years191 years381 years1533 years
54.8 (14.3%)54.7 (28.5%)55.3 (14.3%)55.6 (29.1%)69.5 (18.2%)58.6 (3.8%)
Sex: Female, Male | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed383 participants192 participants386 participants191 participants381 participants1533 participants
Female221 (57.7%)119 (62%)186 (48.2%)85 (44.5%)188 (49.3%)799 (52.1%)
Male162 (42.3%)73 (38%)200 (51.8%)106 (55.5%)193 (50.7%)734 (47.9%)
Race/Ethnicity, Customized | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed383 participants192 participants386 participants191 participants381 participants1533 participants
1 (0.3%)4 (1%)3 (1.6%)1 (0.3%)9 (0.6%)

Outcome Measures

Primary Outcome

TitleRSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
DescriptionSerological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time FrameAt 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Analysis Population DescriptionAnalysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults HA-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed326342
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
7893.5
(7167.5 - 8692.9)
7492.6
(6819.1 - 8232.7)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults HA-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsNon-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterGMT Ratio
Estimated Value0.95
Estimation Comments2-Sided

Primary Outcome

TitleRSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
DescriptionThe SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4).
Time FrameAt 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults HA-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed270275
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
82.8
(78.3 - 86.8)
80.4
(75.8 - 84.5)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults HA-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsThe non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterDifference in percentage
Estimated Value-2.41
Estimation Comments2-Sided

Primary Outcome

TitleRSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
DescriptionSerological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time FrameAt 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults HA-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed326341
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
9009.5
(8226.6 - 9866.6)
8058.2
(7373.1 - 8807.0)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults HA-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsNon-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterGMT Ratio
Estimated Value0.89
Estimation Comments2-Sided

Primary Outcome

TitleRSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
DescriptionThe SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Time FrameAt 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults HA-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed255254
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
78.2
(73.3 - 82.6)
74.5
(69.5 - 79.0)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults HA-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsThe non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterDifference in percentage
Estimated Value-3.73
Estimation Comments2-Sided

Primary Outcome

TitleRSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
DescriptionSerological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time FrameAt 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Analysis Population DescriptionAnalysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults AIR-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed343342
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
8922.7
(8118.2 - 9806.9)
7440.1
(6768.4 - 8178.5)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults AIR-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsNon-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterGMT Ratio
Estimated Value0.83
Estimation Comments2-Sided

Primary Outcome

TitleRSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
DescriptionThe SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Time FrameAt 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-A at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults AIR-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed298275
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
86.9
(82.8 - 90.3)
80.4
(75.8 - 84.5)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults AIR-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsThe non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterDifference in percentage
Estimated Value-6.47
Estimation Comments2-Sided

Primary Outcome

TitleRSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
DescriptionSerological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Time FrameAt 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults AIR-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed343341
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
10054.7
(9225.4 - 10958.7)
8062.8
(7395.9 - 8789.9)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults AIR-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsNon-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterGMT Ratio
Estimated Value0.80
Estimation Comments2-Sided

Primary Outcome

TitleRSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
DescriptionThe SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
Time FrameAt 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had SRR results for RSV-B at pre- and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults AIR-RSV GroupOA-RSV Group
Overall Number of Participants Analyzed280254
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
81.6
(77.1 - 85.6)
74.5
(69.5 - 79.0)

Statistical Analysis 1

Statistical Analysis Overview
Comparison Group SelectionAdults AIR-RSV Group, OA-RSV Group
CommentsTo demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
Type of Statistical TestNon-Inferiority
CommentsThe non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.
Statistical Test of Hypothesis
Method of Estimation
Estimation ParameterDifference in percentage
Estimated Value-7.15
Estimation Comments2-Sided

Secondary Outcome

TitlePercentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
DescriptionAssessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Time FrameDuring the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Analysis Population DescriptionAnalysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited administration site events analysis at the assessed timeframe.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed377191379188379
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
Erythema11.9
(8.8 - 15.6)
0.5
(0.0 - 2.9)
14.5
(11.1 - 18.5)
0.5
(0.0 - 2.9)
12.1
(9.0 - 15.9)
Pain76.4
(71.8 - 80.6)
10.5
(6.5 - 15.7)
75.2
(70.5 - 79.5)
13.8
(9.2 - 19.6)
61.2
(56.1 - 66.1)
Swelling9.3
(6.6 - 12.7)
1.0
(0.1 - 3.7)
11.6
(8.6 - 15.3)
0.5
(0.0 - 2.9)
7.7
(5.2 - 10.8)

Secondary Outcome

TitlePercentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
DescriptionAssessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Time FrameDuring the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Analysis Population DescriptionAnalysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited systemic events analysis at the assessed timeframe.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed377191379189379
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
Arthralgia26.0
(21.6 - 30.7)
5.8
(2.9 - 10.1)
20.8
(16.9 - 25.3)
10.1
(6.2 - 15.3)
12.9
(9.7 - 16.7)
Fatigue43.8
(38.7 - 48.9)
17.3
(12.2 - 23.4)
35.9
(31.0 - 40.9)
19.0
(13.7 - 25.4)
23.7
(19.6 - 28.4)
Headache35.8
(31.0 - 40.9)
16.8
(11.8 - 22.8)
27.7
(23.3 - 32.5)
16.9
(11.9 - 23.1)
21.1
(17.1 - 25.6)
Myalgia39.0
(34.0 - 44.1)
5.8
(2.9 - 10.1)
32.2
(27.5 - 37.2)
13.8
(9.2 - 19.5)
21.1
(17.1 - 25.6)
Fever3.7
(2.0 - 6.2)
1.0
(0.1 - 3.7)
2.6
(1.3 - 4.8)
1.1
(0.1 - 3.8)
1.6
(0.6 - 3.4)

Secondary Outcome

TitlePercentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
DescriptionUnsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time FrameDuring the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Analysis Population DescriptionAnalysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for assessed timeframe and unsolicited events analysis.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed383192386191381
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
13.1
(9.8 - 16.8)
13.5
(9.0 - 19.2)
14.8
(11.4 - 18.7)
9.9
(6.1 - 15.1)
16.3
(12.7 - 20.4)

Secondary Outcome

TitlePercentage of Participants Reporting Any Serious Adverse Events (SAEs)
DescriptionAn SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Time FrameFrom the day of the vaccination (Day 1) up to 6 months post dose (Month 6)
Analysis Population DescriptionAnalysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed383192386191381
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
0.5
(0.1 - 1.9)
2.1
(0.6 - 5.2)
3.6
(2.0 - 6.0)
2.1
(0.6 - 5.3)
2.4
(1.1 - 4.4)

Secondary Outcome

TitlePercentage of Participants Reporting Any Potential Immune Mediated Diseases (pIMDs)
DescriptionpIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time FrameFrom the day of the vaccination (Day 1) up to 6 months post dose (Month 6)
Analysis Population DescriptionAnalysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed383192386191381
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
1.0
(0.3 - 2.6)
0.5
(0.0 - 2.9)
0.8
(0.2 - 2.3)

Secondary Outcome

TitlePercentage of Participants Reporting SAEs Related to Study Intervention Administration
DescriptionAn SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Time FrameFrom the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)

Secondary Outcome

TitlePercentage of Participants Reporting pIMDs Related to Study Intervention Administration
DescriptionpIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time FrameFrom the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)

Secondary Outcome

TitlePercentage of Participants Reporting Any Fatal SAEs
DescriptionAn SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
Time FrameFrom the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)

Secondary Outcome

TitleRSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
DescriptionSerological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA_RSV, Adults HA-Placebo, Adult AIR_RSV, Adult AIR_Placebo and OA_RSV groups.
Time FrameAt pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed347181365186362
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
Day 1768.8
(704.7 - 838.9)
772.0
(677.9 - 879.1)
781.7
(727.5 - 840.0)
729.8
(648.6 - 821.0)
772.2
(706.6 - 843.8)
Day 317925.4
(7125.6 - 8815.0)
796.9
(696.4 - 912.0)
8821.9
(7971.0 - 9763.6)
774.9
(683.7 - 878.3)
7461.9
(6724.9 - 8279.6)

Secondary Outcome

TitleRSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
DescriptionSerological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time FrameAt 6 months and at 12 months after study intervention administration

Secondary Outcome

TitleRSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
DescriptionSerological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA_RSV, Adults HA-Placebo, Adult AIR_RSV, Adult AIR_Placebo and OA_RSV groups.
Time FrameAt pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Analysis Population DescriptionAnalysis was performed on PPS for humoral analysis which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for the assessed analysis, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed347181365186362
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
Day 11091.1
(1000.3 - 1190.2)
1197.7
(1055.7 - 1358.8)
1141.6
(1051.0 - 1240.0)
1167.2
(1035.0 - 1316.1)
1104.2
(1016.2 - 1199.9)
Day 318971.9
(8109.6 - 9925.8)
1145.3
(1012.4 - 1295.5)
9967.3
(9059.3 - 10966.3)
1141.7
(1007.9 - 1293.1)
8144.5
(7388.9 - 8977.4)

Secondary Outcome

TitleRSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
DescriptionSerological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time FrameAt 6 months and at 12 months after study intervention administration

Secondary Outcome

TitleFrequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
DescriptionAmong markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time FrameAt pre-study intervention administration (Day 1) and 1 months after study intervention administration (Day 31)
Analysis Population DescriptionAnalysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed4728552725
Geometric Mean (Standard Deviation) | Unit of Measure: CD4+ T cells/million cells
Day 1102.7 (0.9)125.6 (0.9)161.5 (0.6)114.7 (0.9)108.8 (0.9)
Day 311282.5 (0.4)167.7 (0.8)1043.6 (0.6)131.9 (0.8)1029.2 (0.8)

Secondary Outcome

TitleFrequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
DescriptionAmong markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
Time FrameAt 6 months and at 12 months after study intervention administration

Secondary Outcome

TitleFrequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
DescriptionAmong markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time FrameAt pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Analysis Population DescriptionAnalysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS, which included all eligible participants who received the study intervention as per protocol, had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD8+ T cells, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
Arm/Group TitleAdults HA-RSV GroupAdults HA-Placebo GroupAdults AIR-RSV GroupAdults AIR-Placebo GroupOA-RSV Group
Overall Number of Participants Analyzed4628552725
Geometric Mean (Standard Deviation) | Unit of Measure: CD8+ T cells/million cells
Day 110.1 (1.1)6.0 (0.9)15.5 (1.0)10.8 (1.1)13.2 (1.0)
Day 3115.2 (1.1)11.9 (1.1)18.1 (1.1)4.8 (1.1)13.3 (1.2)

Secondary Outcome

TitleFrequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
DescriptionAmong markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
Time FrameAt 6 months and at 12 months after study intervention administration

Adverse Events

Time FrameSAEs were reported from Day 1 (day of vaccination) until Month 6 post-dose administration. Solicited and unsolicited AEs were reported from Day 1 up to 30 days post dose administration.
Adverse Event Reporting DescriptionNot Specified
Arm/Group TitleAdults HA-RSV Group

Affected / at Risk (%)

Adults HA-Placebo Group

Affected / at Risk (%)

Adults AIR-RSV Group

Affected / at Risk (%)

Adults AIR-Placebo Group

Affected / at Risk (%)

OA-RSV Group

Affected / at Risk (%)

All-Cause Mortality
TotalNot Specified / 383Not Specified / 192Not Specified / 386Not Specified / 191Not Specified / 381
Serious Adverse Events
Total2 / 383 (0.52 %)4 / 192 (2.08 %)14 / 386 (3.63 %)4 / 191 (2.09 %)9 / 381 (2.36 %)
Other (Not Including Serious) Adverse Events
Total323 / 383 (84.33 %)76 / 192 (39.58 %)317 / 386 (82.12 %)72 / 191 (37.7 %)278 / 381 (72.97 %)

Limitations and Caveats

Not Specified

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Email: GSKClinicalSupportHD@gsk.com
Phone: 866-435-7343