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
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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Out 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 Details
The 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Study
STARTED
383
192
386
191
381
COMPLETED
380
191
384
190
381
NOT COMPLETED
3
1
2
1
Array
Lost to Follow-up
3
Array
2
Array
Array
Consent withdrawal, not due to a (S)AE
Array
1
Array
1
Array
Baseline Characteristics
Arm/Group Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Total
Overall Number of Baseline Participants
383
192
386
191
381
1533
Age, Continuous | Measure Type: Mean | Unit of measure: YEARS
Number Analyzed
383 years
192 years
386 years
191 years
381 years
1533 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 Analyzed
383 participants
192 participants
386 participants
191 participants
381 participants
1533 participants
Female
221 (57.7%)
119 (62%)
186 (48.2%)
85 (44.5%)
188 (49.3%)
799 (52.1%)
Male
162 (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 Analyzed
383 participants
192 participants
386 participants
191 participants
381 participants
1533 participants
1 (0.3%)
4 (1%)
3 (1.6%)
1 (0.3%)
9 (0.6%)
Outcome Measures
Primary Outcome
Title
RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
Description
Serological 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 Frame
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
326
342
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 Selection
Adults HA-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
Non-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 Parameter
GMT Ratio
Estimated Value
0.95
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
Description
The 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 Frame
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
270
275
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 Selection
Adults HA-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
The 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 Parameter
Difference in percentage
Estimated Value
-2.41
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
Description
Serological 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 Frame
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
326
341
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 Selection
Adults HA-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
Non-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 Parameter
GMT Ratio
Estimated Value
0.89
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
Description
The 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 Frame
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
255
254
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 Selection
Adults HA-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
The 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 Parameter
Difference in percentage
Estimated Value
-3.73
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-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
Description
Serological 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 Frame
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults AIR-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
343
342
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 Selection
Adults AIR-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
Non-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 Parameter
GMT Ratio
Estimated Value
0.83
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Description
The 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 Frame
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population Description
Analysis 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 Title
Adults AIR-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
298
275
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 Selection
Adults AIR-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
The 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 Parameter
Difference in percentage
Estimated Value
-6.47
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Description
Serological 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 Frame
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults AIR-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
343
341
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 Selection
Adults AIR-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
Non-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 Parameter
GMT Ratio
Estimated Value
0.80
Estimation Comments
2-Sided
Primary Outcome
Title
RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
Description
The 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 Frame
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
Analysis Population Description
Analysis 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 Title
Adults AIR-RSV Group
OA-RSV Group
Overall Number of Participants Analyzed
280
254
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 Selection
Adults AIR-RSV Group, OA-RSV Group
Comments
To 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 Test
Non-Inferiority
Comments
The 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 Parameter
Difference in percentage
Estimated Value
-7.15
Estimation Comments
2-Sided
Secondary Outcome
Title
Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling)
Description
Assessed 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 Frame
During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
377
191
379
188
379
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
Erythema
11.9(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)
Pain
76.4(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)
Swelling
9.3(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
Title
Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness)
Description
Assessed 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 Frame
During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
377
191
379
189
379
Number (95% Confidence Interval) | Unit of Measure: Percentage of participants
Arthralgia
26.0(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)
Fatigue
43.8(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)
Headache
35.8(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)
Myalgia
39.0(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)
Fever
3.7(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
Title
Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs)
Description
Unsolicited 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 Frame
During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
383
192
386
191
381
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
Title
Percentage of Participants Reporting Any Serious Adverse Events (SAEs)
Description
An 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 Frame
From the day of the vaccination (Day 1) up to 6 months post dose (Month 6)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
383
192
386
191
381
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
Title
Percentage of Participants Reporting Any Potential Immune Mediated Diseases (pIMDs)
Description
pIMDs 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 Frame
From the day of the vaccination (Day 1) up to 6 months post dose (Month 6)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
383
192
386
191
381
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
Title
Percentage of Participants Reporting SAEs Related to Study Intervention Administration
Description
An 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 Frame
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Secondary Outcome
Title
Percentage of Participants Reporting pIMDs Related to Study Intervention Administration
Description
pIMDs 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 Frame
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Secondary Outcome
Title
Percentage of Participants Reporting Any Fatal SAEs
Description
An 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 Frame
From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
Secondary Outcome
Title
RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Description
Serological 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 Frame
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
347
181
365
186
362
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
Day 1
768.8(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 31
7925.4(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
Title
RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention
Description
Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time Frame
At 6 months and at 12 months after study intervention administration
Secondary Outcome
Title
RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention
Description
Serological 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 Frame
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
347
181
365
186
362
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titer
Day 1
1091.1(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 31
8971.9(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
Title
RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention
Description
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time Frame
At 6 months and at 12 months after study intervention administration
Secondary Outcome
Title
Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention
Description
Among 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 Frame
At pre-study intervention administration (Day 1) and 1 months after study intervention administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
47
28
55
27
25
Geometric Mean (Standard Deviation) | Unit of Measure: CD4+ T cells/million cells
Day 1
102.7 (0.9)
125.6 (0.9)
161.5 (0.6)
114.7 (0.9)
108.8 (0.9)
Day 31
1282.5 (0.4)
167.7 (0.8)
1043.6 (0.6)
131.9 (0.8)
1029.2 (0.8)
Secondary Outcome
Title
Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention
Description
Among 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 Frame
At 6 months and at 12 months after study intervention administration
Secondary Outcome
Title
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention
Description
Among 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 Frame
At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
Analysis Population Description
Analysis 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 Title
Adults HA-RSV Group
Adults HA-Placebo Group
Adults AIR-RSV Group
Adults AIR-Placebo Group
OA-RSV Group
Overall Number of Participants Analyzed
46
28
55
27
25
Geometric Mean (Standard Deviation) | Unit of Measure: CD8+ T cells/million cells
Day 1
10.1 (1.1)
6.0 (0.9)
15.5 (1.0)
10.8 (1.1)
13.2 (1.0)
Day 31
15.2 (1.1)
11.9 (1.1)
18.1 (1.1)
4.8 (1.1)
13.3 (1.2)
Secondary Outcome
Title
Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12
Description
Among 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 Frame
At 6 months and at 12 months after study intervention administration
Adverse Events
Time Frame
SAEs 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 Description
Not Specified
Arm/Group Title
Adults 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
Total
Not Specified / 383
Not Specified / 192
Not Specified / 386
Not Specified / 191
Not Specified / 381
Serious Adverse Events
Total
2 / 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
Total
323 / 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