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
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: RSV MAT vaccine; dTpa vaccine
Intervention description: Single dose of the RSV MAT vaccine reconstituted with NaCl solution was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.
RSV MAT vaccine was no longer administered to participants at Day 31. No vaccine was administered in the dTpa_RSV-P Group, since there were no participants assigned to it.; Single dose of the dTpa vaccine was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.
Two formulations of dTpa vaccine are licensed in the US and outside of the US (ex-US), respectively. dTpa-US formulation was administered to participants in centers located in the US, while dTpa-ex-US formulation was planned to be administered to participants in centers ex-US. The dTpa-ex-US formulation was not applicable in this study anymore as no non-US sites were initiated before the decision to stop the study.
The participants in RSV_dTpa-P and RSV_dTpa-A study groups were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
No vaccine was administered in the dTpa_RSV-P Group, since there were no participants assigned to it.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The interventional study model was planned to be crossover, but this is no longer applicable as there were no more study activities planned.
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 9 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus Maternal vaccine; Combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine; Reactogenicity; Safety; Immunogenicity; Healthy non-pregnant girl; Healthy non-pregnant adult women

Summary:

      The purpose of this study was to evaluate the reactogenicity, safety and immune response of a
      single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in
      healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49
      YOA. The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis (dTpa)
      vaccine was planned to be used as an active control for safety and reactogenicity evaluation.

      Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV
      MAT 009), GSK made the decision to stop enrolment and vaccination in this study. Enrolled
      study participants were monitored as part of the study until study completion.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy Non-pregnant Adult Women from 18-49 YOA

          -  Participants who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol.

          -  Written or witnessed/thumb printed informed consent obtained from the participant
             prior to performance of any study-specific procedure.

          -  A healthy female participant, as established by medical history and clinical
             examination, between and including 18 to 49 YOA at the time of the first study
             intervention administration.

          -  Body mass index (based on participant's report) 17.0 to 39.9 kg/m^2, inclusive for
             adult participants.

          -  Female participants of childbearing potential may be enrolled in the study, if the
             participant:

               -  has practiced adequate contraception for 1 month prior to study intervention
                  administration, and

               -  has a negative pregnancy test on the day of study intervention administration,
                  and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 1 month after completion of the study intervention administrations.

          -  Female participants of non-childbearing potential may be enrolled in the study.
             Non-childbearing potential is defined as, current bilateral tubal ligation or
             occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

        Healthy non-pregnant Girls from 9-17 YOA

          -  Participants and participants' parent(s)/Legally Acceptable Representative(s) (LAR),
             who, in the opinion of the investigator, can and will comply with the requirements of
             the protocol.

          -  Written or witnessed/thumb printed informed consent obtained from the
             participant*/parent(s)/LAR(s) of the participant prior to performance of any
             study-specific procedure.

               -  *Written informed consent obtained from parents/LARs and written informed assent
                  obtained from the participant if she is less than legal age. The legal age is
                  determined according to local regulations in each participating country.

               -  In case the legal age is achieved during the conduct of the study, an additional
                  written informed consent from the participant should be obtained at the time of
                  the legal age.

          -  A healthy female participant between and including 9 and 17 YOA at the time of the
             first study intervention administration.

               -  Female participants of non-childbearing potential may be enrolled in the study.
                  Non-childbearing potential is defined as pre-menarche, current bilateral tubal
                  ligation or occlusion, hysterectomy, or bilateral ovariectomy.

          -  Body mass index by age between 5 percentile and 95 percentile (inclusive) for
             pediatric participants.

          -  Female participants of childbearing potential may be enrolled in the study, if the
             participant:

               -  has a negative pregnancy test on the day of study intervention administration,
                  and is abstinent during the entire treatment period and for 1 month before and
                  after completion of the study intervention administration series (and if so, this
                  is to be documented in the source documents at each vaccination visit)

               -  or has practiced adequate contraception for 1 month prior to study intervention
                  administration and has agreed to continue adequate contraception during the
                  entire treatment period and for 1 month after completion of the study
                  intervention administration series.

        Exclusion Criteria:

        Medical conditions

          -  Any clinical condition that, in the opinion of the investigator, might pose additional
             risk to the participant due to participation in the study.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the study intervention(s).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Current autoimmune disorder (based on medical history and physical examination), for
             which the participant has received immune-modifying therapy within 6 months, before
             study vaccination.

          -  Hypersensitivity to latex.

          -  Acute or chronic clinically significant abnormality or poorly controlled pre-existent
             co-morbidities or any other clinical conditions, as determined by physical examination
             or medical history that, in the opinion of the investigator, might pose additional
             risk to the participant due to participation in the study.

          -  Significant or uncontrolled psychiatric illness.

          -  Documented human immunodeficiency virus (HIV)-positive participant.

          -  Any clinically significant* hematological parameter and/or biochemical laboratory
             abnormality from the test requested by the investigator based on medical judgment
             prior to enrolment

               -  *The investigator should use his/her clinical judgment to decide whether the test
                  is needed, and which abnormalities are clinically significant. If he/she decides
                  to run this test, the investigator will need to review the test results before
                  proceeding with the administration of the study vaccine.

          -  Lymphoproliferative disorder or malignancy within 5 years before study vaccination
             (excluding effectively treated non-melanoma skin cancer).

        Prior/Concomitant therapy

          -  Use of any investigational or non-registered product (drug, vaccine or medical device)
             other than the study intervention(s) during the period beginning 30 days before the
             first doses (Day -29 to Day 1), or their planned use during the study period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within the period starting 30 days before the first dose and ending 30 days after the
             last dose of study intervention(s)* administration with the exception of any licensed
             influenza vaccine which may be administered ≥ 15 days before or after study
             vaccinations (dTpa and RSV maternal vaccines).

               -  *In case emergency mass vaccination for an unforeseen public health threat (e.g.
                  a pandemic) is organized by public health authorities outside the routine
                  immunization program, the time period described above can be reduced if necessary
                  for that vaccine (if it is used according to the local governmental
                  recommendations and that the Sponsor is notified accordingly). Therefore,
                  COVID-19 vaccines will be allowed, when administered ≥ 15 days before or after
                  study vaccinations (dTpa and RSV maternal vaccines).

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period (e.g. infliximab).

          -  Administration of immunoglobulins and/or any blood products or plasma derivatives
             during the period starting 3 months before the administration of the first dose of
             study intervention(s) or planned administration during the study period.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs during the period starting 3 months prior to the first
             study intervention dose(s) to 2 months after first vaccination. For corticosteroids,
             this will mean prednisone equivalent ≥5 mg/day for adult participants/ ≥0.5 mg/kg/day.
             Inhaled and topical steroids are allowed.

          -  Previous experimental vaccination against RSV.

          -  Boostrix (dTpa) administration for which the vaccination is not aligned with the local
             recommendations for dTap vaccination or not aligned with the locally approved Boostrix
             (dTpa) prescribing information.

        Prior/Concurrent clinical study experience

        • Concurrently participating in another clinical study, at any time during the study
        period, in which the participant has been or will be exposed to an investigational or a
        non-investigational intervention (drug/invasive medical device).

        Other exclusions

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Alcoholism or substance use disorder within the past 24 months based on the presence
             of two or more of the following abuse criteria: hazardous use, social/interpersonal
             problems related to use, neglected major roles to use, withdrawal tolerance, use of
             larger amounts or longer, repeated attempts to quit or control use, much time spent
             using, physical or psychological problems related to use, activities given up to use,
             craving.

          -  Any study personnel or their immediate dependents, family, or household members.

          -  Child in care.