Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase III, randomized, open-label, active vaccine-controlled crossover study to evaluate the reactogenicity, safety and immune response of unadjuvanted RSV maternal vaccine in healthy non-pregnant girls from 9 to 17 years of age, and in non-pregnant adult women from 18 to 49 years of age

    Summary
    EudraCT number
    		 2021-004003-41
    Trial protocol
    		 ES  
    Global end of trial date
    03 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Feb 2023
    First version publication date
    22 Feb 2023
    Other versions
    Summary report(s)
    		 Statement on cancellation before enrollment and results availability - 217354

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    217354
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05169905
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002821-PIP01-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the safety following administration of RSV maternal vaccine in the pediatric (9-17 YOA) and adult (18-49 YOA) study groups during the entire study period (180 days post RSV maternal vaccination). • To evaluate the reactogenicity and safety following administration of RSV maternal vaccine and dTpa control vaccine in the pediatric and adult study groups up to 30 days (including day of study intervention administration).
    Protection of trial subjects
    Study participants were observed closely for at least 30 minutes after the administration of the study intervention(s). Appropriate medical treatment was readily available during the observation period in case of anaphylaxis, syncope. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible participants that had no contraindications to any components of the vaccines/products. Study participants were followed-up for 180 days after the administration of study intervention(s).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    2
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 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.

    Pre-assignment
    Screening details
    		 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV_dTpa-P Group
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSV MAT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of the RSV MAT vaccine reconstituted with NaCl solution was administered in the non-dominant arm at Day 1.

    Arm title
    		 RSV_dTpa-A Group
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSV MAT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of the RSV MAT vaccine reconstituted with NaCl solution was administered in the non-dominant arm at Day 1.

    Arm title
    		 dTpa_RSV-A Group
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    dTpa
    Investigational medicinal product code
    Other name
    Boostrix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of the dTpa vaccine was administered in the non-dominant arm at Day 1.

    Number of subjects in period 1 [1]
    		RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Started
    1
    3
    4
    Completed
    1
    3
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 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.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    RSV_dTpa-P Group
    Reporting group description
    		 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.

    Reporting group title
    RSV_dTpa-A Group
    Reporting group description
    		 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.

    Reporting group title
    dTpa_RSV-A Group
    Reporting group description
    		 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.

    Reporting group values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group Total
    Number of subjects
    		 1 3 4 8
    Age categorical
    Units: Participants
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 1 0 0 1
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 3 4 7
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Age and its descriptive analysis is presented for adult participants only. There was only one participant in the pediatric age group, hence the mean and standard deviation could not be calculated, and therefore the age continuous data for this group is indicated as 0.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 42.3 ( 2.5 ) 38.0 ( 9.4 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 1 3 4 8
        Male
    		 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        BLACK OR AFRICAN AMERICAN
    		 1 0 0 1
        WHITE
    		 0 3 4 7

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    RSV_dTpa-P Group
    Reporting group description
    		 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.

    Reporting group title
    RSV_dTpa-A Group
    Reporting group description
    		 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.

    Reporting group title
    dTpa_RSV-A Group
    Reporting group description
    		 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.

    Primary: Number of participants reporting any serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of participants reporting any serious adverse events (SAEs) [1]
    End point 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 abnormal pregnancy outcomes. Any is defined as the occurrence of the symptom regardless of intensity grade or relationship to vaccination. The analysis was performed on the Exposed Set, which included all participants who received the study intervention (RSV maternal vaccine or dTpa vaccine).
    End point type
    Primary
    End point timeframe
    During the entire study period (from Day 1 up to Day 181)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants reporting adverse events (AEs)/SAEs leading to study withdrawal

    		 Close Top of page
    End point title
    		 Number of participants reporting adverse events (AEs)/SAEs leading to study withdrawal [2]
    End point description
    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. The analysis was performed on the Exposed Set.
    End point type
    Primary
    End point timeframe
    During the entire study period (from Day 1 up to Day 181)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants reporting any solicited administration site events

    		 Close Top of page
    End point title
    		 Number of participants reporting any solicited administration site events [3]
    End point description
    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. The analysis was performed on the Solicited Safety Set, which included all participants in the Exposed Set who have solicited safety data.
    End point type
    Primary
    End point timeframe
    During the 7 days follow-up period post-Dose 1
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
        Pain
    1
    1
    3
        Erythema
    0
    0
    1
        Swelling
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants reporting any solicited systemic events

    		 Close Top of page
    End point title
    		 Number of participants reporting any solicited systemic events [4]
    End point description
    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. The analysis was performed on the Solicited Safety Set.
    End point type
    Primary
    End point timeframe
    During the 7 days follow-up period post-Dose 1
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
        Fatigue
    0
    1
    1
        Headache
    0
    1
    2
        Nausea
    0
    1
    0
        Vomiting
    0
    0
    0
        Diarrhea
    0
    2
    2
        Abdominal pain
    0
    1
    0
        Fever
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants reporting any unsolicited AEs

    		 Close Top of page
    End point title
    		 Number of participants reporting any unsolicited AEs [5]
    End point description
    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. The analysis was performed on the Exposed Set.
    End point type
    Primary
    End point timeframe
    During the 30 days follow-up period post-Dose 1
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
    0
    1
    1
    No statistical analyses for this end point

    Primary: Number of participants reporting SAEs and medically attended adverse events (MAEs)

    		 Close Top of page
    End point title
    		 Number of participants reporting SAEs and medically attended adverse events (MAEs) [6]
    End point 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 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. The analysis was performed on the Exposed Set.
    End point type
    Primary
    End point timeframe
    During the 30 days follow-up period post-Dose 1
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants reporting AEs/SAEs/MAEs leading to study withdrawal

    		 Close Top of page
    End point title
    		 Number of participants reporting AEs/SAEs/MAEs leading to study withdrawal [7]
    End point description
    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. The analysis was performed on the Exposed Set.
    End point type
    Primary
    End point timeframe
    During the 30 days follow-up period post-Dose 1
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Number of subjects analysed
    1
    3
    4
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: RSV-A neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1

    		 Close Top of page
    End point title
    		 RSV-A neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1 [8]
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    At pre-dosing (Day 1)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for participants who received the RSV MAT vaccine.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group
    Number of subjects analysed
    1
    3
    Units: Titers (ED60)
    number (not applicable)
        Participant 1 (N=1;1)
    86
    1355
        Participant 2 (N=0;1)
    0
    792
        Participant 3 (N=0;1)
    0
    177
    No statistical analyses for this end point

    Secondary: RSV-A neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31

    		 Close Top of page
    End point title
    		 RSV-A neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31 [9]
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    At 30 days post-RSV MAT vaccine administration (Day 31)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for participants who received the RSV MAT vaccine.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group
    Number of subjects analysed
    1
    3
    Units: Titers (ED60)
    number (not applicable)
        Participant 1 (N=1;1)
    1702
    21707
        Participant 2 (N=0;1)
    0
    38258
        Participant 3 (N=0;1)
    0
    17765
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1

    		 Close Top of page
    End point title
    		 RSV-B neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1 [10]
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    At pre-dosing (Day 1)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for participants who received the RSV MAT vaccine.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group
    Number of subjects analysed
    1
    3
    Units: Titers (ED60)
    number (not applicable)
        Participant 1 (N=1;1)
    373
    2434
        Participant 2 (N=0;1)
    0
    525
        Participant 3 (N=0;1)
    0
    461
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31

    		 Close Top of page
    End point title
    		 RSV-B neutralizing antibody titers for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31 [11]
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    At 30 days post-RSV MAT vaccine administration (Day 31)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for participants who received the RSV MAT vaccine.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group
    Number of subjects analysed
    1
    3
    Units: Titers (ED60)
    number (not applicable)
        Participant 1 (N=1;1)
    2089
    138336
        Participant 2 (N=0;1)
    0
    14233
        Participant 3 (N=0;1)
    0
    34743
    No statistical analyses for this end point

    Secondary: RSV MAT immunoglobulin G (IgG) antibody concentrations for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1

    		 Close Top of page
    End point title
    		 RSV MAT immunoglobulin G (IgG) antibody concentrations for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1 [12]
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    At pre-dosing (Day 1)
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for participants who received the RSV MAT vaccine.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group
    Number of subjects analysed
    1
    3
    Units: EU/mL
    number (not applicable)
        Participant 1 (N=1;1)
    1949
    4967
        Participant 2 (N=0;1)
    0
    3279
        Participant 3 (N=0;1)
    0
    4727
    No statistical analyses for this end point

    Secondary: RSV MAT IgG antibody concentrations for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31

    		 Close Top of page
    End point title
    		 RSV MAT IgG antibody concentrations for participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31 [13]
    End point description
    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. 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.
    End point type
    Secondary
    End point timeframe
    At 30 days post-RSV MAT vaccine administration (Day 31)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for participants who received the RSV MAT vaccine.
    End point values
    		 RSV_dTpa-P Group RSV_dTpa-A Group
    Number of subjects analysed
    1
    3
    Units: EU/mL
    number (not applicable)
        Participant 1 (N=1;1)
    50193
    149510
        Participant 2 (N=0;1)
    0
    218190
        Participant 3 (N=0;1)
    0
    402812
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    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).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    RSV_dTpa-P Group
    Reporting group description
    		 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.

    Reporting group title
    RSV_dTpa-A Group
    Reporting group description
    		 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.

    Reporting group title
    dTpa_RSV-A Group
    Reporting group description
    		 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.

    Serious adverse events
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RSV_dTpa-P Group RSV_dTpa-A Group dTpa_RSV-A Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    3 / 4 (75.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
         occurrences all number
    0
    3
    2
    General disorders and administration site conditions
    Administration site pain
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    3 / 4 (75.00%)
         occurrences all number
    1
    1
    9
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    0
    5
    2
    Administration site erythema
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    2 / 3 (66.67%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    2
    Abdominal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    4
    0
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Hypomenorrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2022
    • Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants continued to be monitored as part of the study. • There were no new participants included in this study. There were 9 participants enrolled in this study. However, one subject withdrew after giving consent but before randomization and any study intervention administration. Thus, safety follow-up continued until the end of the study period (180 days post vaccination) for all 8 participants enrolled and vaccinated at a study site in the US. • The vaccination planned at Visit 2 was removed. Therefore, Contact 2 at Day 38 and Visit 3 at Day 61 were not applicable anymore. Visit 4a (Day 181) and Visit 4b (Day 211) were replaced by a telephone contact at Day 181. • A blood sample for immunogenicity assessment in the study participants who received first dose of RSV Maternal vaccine continued to be collected at Visit 2 only. No other blood samples were collected. • All planned objectives were analysed and reported in a descriptive manner for the 8 enrolled and vaccinated participants.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 05:23:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA