Trial Outcomes & Findings for A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age (NCT NCT05169905)
NCT ID: NCT05169905
Last Updated: 2023-04-07
Results Overview
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 abnormal pregnancy outcomes. Any is defined as the occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
During the entire study period (from Day 1 up to Day 181)
Results posted on
2023-04-07
Participant Flow
The study was planned to enroll 252 participants in 4 groups as per Protocol. However, due to early stoppage of enrolment and further vaccination, only 9 participants were enrolled in the study, out of which 8 participants were assigned to individual groups, except for the dTpa\_RSV-P group, hence this group was not included in the results record.
Out of the 9 participants enrolled in the study, 1 participant withdrew consent before being assigned to any of the groups and was not vaccinated. 8 participants were vaccinated and were included in the Exposed set.
Participant milestones
| Measure |
RSV_dTpa-P Group
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
4
|
|
Overall Study
COMPLETED
|
1
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
Baseline characteristics by cohort
| Measure |
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
Total
n=8 Participants
Total of all reporting groups
|
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
38.0 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
39.9 Years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 1 up to Day 181)Population: The analysis was performed on the Exposed Set, which included all participants who received the study intervention (RSV maternal vaccine or dTpa vaccine).
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 abnormal pregnancy outcomes. Any is defined as the occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 1 up to Day 181)Population: The analysis was performed on the Exposed Set, which included all participants who received the study intervention (RSV maternal vaccine or dTpa vaccine).
An AE is any untoward medical occurrence, symptom, or disease in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. 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 abnormal pregnancy outcomes. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)/SAEs Leading to Study Withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7 days follow-up period post-Dose 1Population: The analysis was performed on the Solicited Safety Set, which included all participants in the Exposed Set who have solicited safety data.
Assessed solicited administration site events include pain, erythema and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter lower than or equal to 20 millimeters.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events
Pain
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Erythema
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7 days follow-up period post-Dose 1Population: The analysis was performed on the Solicited Safety Set, which included all participants in the Exposed Set who have solicited safety data.
Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 °C/100.4°F. Any is defined as the occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
Abdominal pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fatigue
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Headache
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Diarrhea
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 30 days follow-up period post-Dose 1Population: The analysis was performed on the Exposed Set, which included all participants who received the study intervention (RSV maternal vaccine or dTpa vaccine).
An unsolicited AE is an event 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 is reported as an unsolicited adverse event. Any is defined as the occurrence of the unsolicited AE regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 30 days follow-up period post-Dose 1Population: The analysis was performed on the Exposed Set, which included all participants who received the study intervention (RSV maternal vaccine or dTpa vaccine).
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 abnormal pregnancy outcomes. An MAE is an unsolicited AE for which the participants receive medical attention, defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting SAEs and Medically Attended Adverse Events (MAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 30 days follow-up period post-Dose 1Population: The analysis was performed on the Exposed Set, which included all participants who received the study intervention (RSV maternal vaccine or dTpa vaccine).
An AE is any untoward medical occurrence, symptom, or disease in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. 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 abnormal pregnancy outcomes. An MAE is an unsolicited AE for which the participants received medical attention defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
Number of Participants Reporting AEs/SAEs/MAEs Leading to Study Withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At pre-dosing (Day 1)Population: Due to a small number of participants assigned to the study groups, geometric mean titers could not be summarized for this outcome measure. Hence, antibody titer was reported for each participant evaluated in the respective arm, who received the RSV MAT vaccine and had individual immunogenicity data available at the specified time point.
RSV-A neutralizing antibody titer expressed in Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60) is presented for each participant who received the RSV MAT vaccine and was assigned to the respective group.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 1
|
86 Titers (ED60)
|
1355 Titers (ED60)
|
—
|
|
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 2
|
—
|
792 Titers (ED60)
|
—
|
|
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 3
|
—
|
177 Titers (ED60)
|
—
|
SECONDARY outcome
Timeframe: At 30 days post-RSV MAT vaccine administration (Day 31)Population: Due to a small number of participants assigned to the study groups, geometric mean titers could not be summarized for this outcome measure. Hence, antibody titer was reported for each participant evaluated in the respective arm, who received the RSV MAT vaccine and had individual immunogenicity data available at the specified time point.
RSV-A neutralizing antibody titer expressed in ED60 is presented for each participant who received the RSV MAT vaccine and was assigned to the respective group.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 1
|
1702 Titers (ED60)
|
21707 Titers (ED60)
|
—
|
|
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 2
|
—
|
38258 Titers (ED60)
|
—
|
|
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 3
|
—
|
17765 Titers (ED60)
|
—
|
SECONDARY outcome
Timeframe: At pre-dosing (Day 1)Population: Due to a small number of participants assigned to the study groups, geometric mean titers could not be summarized for this outcome measure. Hence, antibody titer was reported for each participant evaluated in the respective arm, who received the RSV MAT vaccine and had individual immunogenicity data available at the specified time point.
RSV-B neutralizing antibody titer expressed in ED60 is presented for each participant who received the RSV MAT vaccine and was assigned to the respective group.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 1
|
373 Titers (ED60)
|
2434 Titers (ED60)
|
—
|
|
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 2
|
—
|
525 Titers (ED60)
|
—
|
|
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 3
|
—
|
461 Titers (ED60)
|
—
|
SECONDARY outcome
Timeframe: At 30 days post-RSV MAT vaccine administration (Day 31)Population: Due to a small number of participants assigned to the study groups, geometric mean titers could not be summarized for this outcome measure. Hence, antibody titer was reported for each participant evaluated in the respective arm, who received the RSV MAT vaccine and had individual immunogenicity data available at the specified time point.
RSV-B neutralizing antibody titer expressed in ED60 is presented for each participant who received the RSV MAT vaccine and was assigned to the respective group.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 1
|
2089 Titers (ED60)
|
138336 Titers (ED60)
|
—
|
|
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 2
|
—
|
14233 Titers (ED60)
|
—
|
|
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 3
|
—
|
34743 Titers (ED60)
|
—
|
SECONDARY outcome
Timeframe: At pre-dosing (Day 1)Population: Due to a small number of participants assigned to the study groups, geometric mean concentrations could not be summarized for this outcome measure. Hence, antibody concentration was reported for each participant evaluated in the respective arm, who received the RSV MAT vaccine and had individual immunogenicity data available at the specified time point.
RSV MAT IgG antibody concentration expressed in ELISA units per milliliter (EU/mL) is presented for each participant who received the RSV MAT vaccine and was assigned to the respective group.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 1
|
1949 EU/mL
|
4967 EU/mL
|
—
|
|
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 2
|
—
|
3279 EU/mL
|
—
|
|
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Participant 3
|
—
|
4727 EU/mL
|
—
|
SECONDARY outcome
Timeframe: At 30 days post-RSV MAT vaccine administration (Day 31)Population: Due to a small number of participants assigned to the study groups, geometric mean concentrations could not be summarized for this outcome measure. Hence, antibody concentration was reported for each participant evaluated in the respective arm, who received the RSV MAT vaccine and had individual immunogenicity data available at the specified time point.
RSV MAT IgG antibody concentration expressed in EU/mL is presented for each participant who received the RSV MAT vaccine and was assigned to the respective group.
Outcome measures
| Measure |
RSV_dTpa-P Group
n=1 Participants
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 Participants
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 1
|
50193 EU/mL
|
149510 EU/mL
|
—
|
|
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 2
|
—
|
218190 EU/mL
|
—
|
|
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Participant 3
|
—
|
402812 EU/mL
|
—
|
Adverse Events
RSV_dTpa-P Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RSV_dTpa-A Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
dTpa_RSV-A Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RSV_dTpa-P Group
n=1 participants at risk
Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
RSV_dTpa-A Group
n=3 participants at risk
Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration).
Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
|
dTpa_RSV-A Group
n=4 participants at risk
Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.
|
|---|---|---|---|
|
General disorders
Administration site pain
|
100.0%
1/1 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
33.3%
1/3 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
75.0%
3/4 • Number of events 9 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
General disorders
Fatigue
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
33.3%
1/3 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
25.0%
1/4 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
General disorders
Administration site erythema
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
0.00%
0/3 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
66.7%
2/3 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
50.0%
2/4 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
33.3%
1/3 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
0.00%
0/4 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
33.3%
1/3 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
0.00%
0/4 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
33.3%
1/3 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
50.0%
2/4 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
33.3%
1/3 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
0.00%
0/4 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
0.00%
0/3 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from study start (Day 1) up to 180 days after vaccination (Day 181).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER