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

NCT05169905 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2173542021-004003-41
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  At pre-dosing (Day 1)

Study Arms (4)

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.

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.

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.

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.

Combination Product: RSV MAT vaccine; Combination Product: dTpa vaccine

Interventions

RSV MAT vaccine COMBINATION_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.

RSV_dTpa-A Group; RSV_dTpa-P Group; dTpa_RSV-A Group; dTpa_RSV-P Group

dTpa vaccine COMBINATION_PRODUCT

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.

Also known as: Boostrix

RSV_dTpa-A Group; RSV_dTpa-P Group; dTpa_RSV-A Group; dTpa_RSV-P Group

Eligibility Criteria

• Age: 9 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Miami, Florida, 33142, United States

Location

GSK Investigational Site

Beaumont, Texas, 77706, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Tetanus

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The interventional study model was planned to be crossover, but this is no longer applicable as there were no more study activities planned.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 27, 2021
• Study Start: February 2, 2022
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (2)