Phase 3 N=8 Randomized Prevention

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

Respiratory Syncytial Virus Infections

Bottom Line

View on ClinicalTrials.gov: NCT05169905 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Number of Participants Reporting Any Serious Adverse Events (SAEs) — 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: RSV MAT vaccine (Combination_product); dTpa vaccine (Combination_product)
Age: Pediatric, Adult · 9+ yrs
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Any Serious Adverse Events (SAEs)	0; 0; 0	—
PRIMARY Number of Participants Reporting Adverse Events (AEs)/SAEs Leading to Study Withdrawal	0; 0; 0	—
PRIMARY Number of Participants Reporting Any Solicited Administration Site Events	1; 1; 3; 0; 0; 1	—
PRIMARY Number of Participants Reporting Any Solicited Systemic Events	0; 1; 1; 0; 1; 2	—
PRIMARY Number of Participants Reporting Any Unsolicited AEs	0; 1; 1	—
PRIMARY Number of Participants Reporting SAEs and Medically Attended Adverse Events (MAEs)	0; 0; 0	—
PRIMARY Number of Participants Reporting AEs/SAEs/MAEs Leading to Study Withdrawal	0; 0; 0	—
SECONDARY RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1	86; 1355; 792; 177	—
SECONDARY RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31	1702; 21707; 38258; 17765	—
SECONDARY RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1	373; 2434; 525; 461	—
SECONDARY RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31	2089; 138336; 14233; 34743	—
SECONDARY RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1	1949; 4967; 3279; 4727	—
SECONDARY RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31	50193; 149510; 218190; 402812	—

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-e

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05169905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.