Respiratory Syncytial Virus InfectionsPhase 3NCT05169905
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
A Phase 3 study testing RSV MAT vaccine and dTpa vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSV MAT vaccine and dTpa vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2022to 3 Aug 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Beaumont, Texas, 77706
GSK Investigational Site
Miami, Florida, 33142
About this study
Official title: 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
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSV MAT vaccine, dTpa vaccine
- 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
- Medical subject headings
- Respiratory Syncytial Virus Infections, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV MAT vaccineCombination product
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.
dTpa vaccineCombination product
Also called Boostrix
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.
| Study group | Role | What they receive |
|---|---|---|
| RSV_dTpa-P Group | Experimental | 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. Receives: Combination Product: RSV MAT vaccine; Combination Product: dTpa vaccine |
| dTpa_RSV-P Group | Experimental | Healthy non-pregnant girls 9-17 years of age were scheduled to receive a single dose of dTpa vaccine at Day 1 and a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration), but there were no participants assigned to this study group, and hence, there was no vaccine administered in this study group. Receives: Combination Product: RSV MAT vaccine; Combination Product: dTpa vaccine |
| RSV_dTpa-A Group | Experimental | 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. Receives: Combination Product: RSV MAT vaccine; Combination Product: dTpa vaccine |
| dTpa_RSV-A Group | Experimental | 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. Receives: Combination Product: RSV MAT vaccine; Combination Product: dTpa vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Any Serious Adverse Events (SAEs)
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.
Measured: During the entire study period (from Day 1 up to Day 181)
Number of Participants Reporting Adverse Events (AEs)/SAEs Leading to Study Withdrawal
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.
Measured: During the entire study period (from Day 1 up to Day 181)
Number of Participants Reporting Any Solicited Administration Site Events
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.
Measured: During the 7 days follow-up period post-Dose 1
Number of Participants Reporting Any Solicited Systemic Events
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.
Measured: During the 7 days follow-up period post-Dose 1
Number of Participants Reporting Any Unsolicited AEs
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.
Measured: During the 30 days follow-up period post-Dose 1
Number of Participants Reporting SAEs and Medically Attended Adverse Events (MAEs)
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.
Measured: During the 30 days follow-up period post-Dose 1
Number of Participants Reporting AEs/SAEs/MAEs Leading to Study Withdrawal
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.
Measured: During the 30 days follow-up period post-Dose 1
Secondary outcomes (6)
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
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.
Measured: At pre-dosing (Day 1)
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
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.
Measured: At 30 days post-RSV MAT vaccine administration (Day 31)
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
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.
Measured: At pre-dosing (Day 1)
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
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.
Measured: At 30 days post-RSV MAT vaccine administration (Day 31)
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
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.
Measured: At pre-dosing (Day 1)
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
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.
Measured: At 30 days post-RSV MAT vaccine administration (Day 31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start2 Feb 2022
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169905
- Sponsor's protocol ID
- 217354
- Other IDs
- 2021-004003-41
- Status last verified
- Apr 2023
- First submitted
- 10 Dec 2021
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05169905
- Acronym / sponsor ID
- 217354
- Conditions
- Respiratory Syncytial Virus Infections
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| RSV_dTpa-P Group | Experimental | Combination Product: RSV MAT vaccine, Combination Product: dTpa vaccineHealthy 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. |
| dTpa_RSV-P Group | Experimental | Combination Product: RSV MAT vaccine, Combination Product: dTpa vaccineHealthy non-pregnant girls 9-17 years of age were scheduled to receive a single dose of dTpa vaccine at Day 1 and a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration), but there were no participants assigned to this study group, and hence, there was no vaccine administered in this study group. |
| RSV_dTpa-A Group | Experimental | Combination Product: RSV MAT vaccine, Combination Product: dTpa vaccineHealthy 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 | Experimental | Combination Product: RSV MAT vaccine, Combination Product: dTpa vaccineHealthy 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. |
Who may qualify
- Ages
- 9 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV MAT vaccineSingle 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. | Combination product | RSV_dTpa-A Group, RSV_dTpa-P Group, dTpa_RSV-A Group, dTpa_RSV-P Group |
| dTpa vaccineAlso: BoostrixSingle 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. | Combination product | RSV_dTpa-A Group, RSV_dTpa-P Group, dTpa_RSV-A Group, dTpa_RSV-P Group |
Primary outcome
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 1 up to Day 181)
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.
Number of Participants Reporting Adverse Events (AEs)/SAEs Leading to Study Withdrawal
Time frame: During the entire study period (from Day 1 up to Day 181)
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.
Number of Participants Reporting Any Solicited Administration Site Events
Time frame: During the 7 days follow-up period post-Dose 1
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.
Number of Participants Reporting Any Solicited Systemic Events
Time frame: During the 7 days follow-up period post-Dose 1
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.
Number of Participants Reporting Any Unsolicited AEs
Time frame: During the 30 days follow-up period post-Dose 1
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.
Number of Participants Reporting SAEs and Medically Attended Adverse Events (MAEs)
Time frame: During the 30 days follow-up period post-Dose 1
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.
Number of Participants Reporting AEs/SAEs/MAEs Leading to Study Withdrawal
Time frame: During the 30 days follow-up period post-Dose 1
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.
6 secondary outcomes
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Time frame: At pre-dosing (Day 1)
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Time frame: At 30 days post-RSV MAT vaccine administration (Day 31)
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Time frame: At pre-dosing (Day 1)
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Time frame: At 30 days post-RSV MAT vaccine administration (Day 31)
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Time frame: At pre-dosing (Day 1)
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Time frame: At 30 days post-RSV MAT vaccine administration (Day 31)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Following a safety signal observed in the RSV MAT-009 (NCT04605159) study, GSK decided to stop further enrollment and vaccination in this study. Results obtained from the RSV MAT-009 study are available on page 60 in the abstract link provided.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RSV MAT vaccine and dTpa vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Any Serious Adverse Events (SAEs) (time frame: During the entire study period (from Day 1 up to Day 181)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.