A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.

NCT05045144 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2147092021-000357-26
• Study Type: interventional
• Target: 1,586
• Locations: 5 countries
• Sites: 36

Brief Summary

The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus Maternal vaccine; Flu Quadrivalent influenza vaccine; Lot-to-lot consistency; Immunogenicity; Safety; Reactogenicity

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

  Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

  From Day 1 to Day 7 (including Day 7)

• Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

  Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

  From Day 1 to Day 7 (including Day 7)

• Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

  An unsolicited AE is any AE 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. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

  From Day 1 to Day 30 (including Day 30)

• Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

  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 i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

  From Day 1 to Day 30 (including Day 30)

• Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group

  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.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

  From first vaccination up to study end (Day 1 to Day 181)

• RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31

  Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots.

  At Day 31

• Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31

  Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine.

  At Day 31

Secondary Outcomes (9)

• RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

  At Day 1 and Day 31

• Seroconversion Rate (SCR) to Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31

  At Day 31

• RSV B Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

  At Day 1 and Day 31

• RSV MAT IgG Concentrations for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31

  At Day 1 and Day 31

• Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31

  At Day 1 and Day 31

Study Arms (5)

RSV lot1 Group

EXPERIMENTAL

Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.

Combination Product: RSVPreF3(120 μg)

RSV lot2 Group

EXPERIMENTAL

Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.

Combination Product: RSVPreF3(120 μg)

RSV lot3 Group

EXPERIMENTAL

Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.

Combination Product: RSVPreF3(120 μg)

RSV+Flu pooled Group

EXPERIMENTAL

Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.

Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA)

Flu+Placebo Group

ACTIVE COMPARATOR

Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.

Combination Product: Flu Quadrivalent influenza vaccine (15 μg HA); Combination Product: Placebo

Interventions

RSVPreF3(120 μg) COMBINATION_PRODUCT

A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.

RSV lot1 Group; RSV lot2 Group; RSV lot3 Group

Flu Quadrivalent influenza vaccine (15 μg HA) COMBINATION_PRODUCT

A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).

Flu+Placebo Group; RSV+Flu pooled Group

Placebo COMBINATION_PRODUCT

One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.

Flu+Placebo Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Only healthy non-pregnant women 18-49 YOA are included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration.
• 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 administration.
• No local condition precluding injection in both left and right deltoid muscles.

You may not qualify if:

• Medical conditions
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions;
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
• Current autoimmune disorder, 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;
• Recurrent history or uncontrolled neurological disorders or seizures;
• Documented HIV-positive participant;
• Body mass index \> 40 kg/m\^2;
• Any clinically significant\* hematological parameter and/or biochemical laboratory abnormality.
• \*The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• Prior/Concomitant therapy
• Use of any investigational or non-registered product other than the study intervention(s) during the period starting 30 days before study intervention (Day -29 to Day 1), or planned use during the study period;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (36)

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Peoria, Illinois, 61614, United States

Location

GSK Investigational Site

Springfield, Missouri, 65802, United States

Location

GSK Investigational Site

Seattle, Washington, 98105, United States

Location

GSK Investigational Site

Surrey, British Columbia, V3S 2N6, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 2T1, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

London, Ontario, N5W 6A2, Canada

Location

GSK Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Mirabel, Quebec, J7J 2K8, Canada

Location

GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

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GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1L 0H8, Canada

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

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GSK Investigational Site

Pori, 28100, Finland

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GSK Investigational Site

Seinäjoki, 60100, Finland

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GSK Investigational Site

Tampere, 33100, Finland

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GSK Investigational Site

Turku, 20520, Finland

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GSK Investigational Site

Gyeonggi-do, 15355, South Korea

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GSK Investigational Site

Seoul, 07441, South Korea

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GSK Investigational Site

Seoul, 08308, South Korea

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GSK Investigational Site

Alcorcón/Madrid, 28922, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Majadahonda (Madrid), 28222, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Valencia, 46015, Spain

Location

Related Publications (1)

• Chime N, Anspach B, Jain V, Laajalahti O, Ollinger T, Yaplee D, Kim JH. Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine. J Infect Dis. 2025 Feb 4;231(1):e144-e153. doi: 10.1093/infdis/jiae342.

  PMID: 38970327 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind (lot-to-lot consistency) \& single-blind (immunogenicity, safety and reactogenicity)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 16, 2021
• Study Start: October 26, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-09

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, 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

FI (9); CA (11); KR (3); US (5); ES (8)