A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1029
- Locations
- 1
- Primary Endpoint
- RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •A male or female ≥65 years of age at the time of the first study intervention administration.
- •Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
- •Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
- •Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion Criteria
- •Medical conditions
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Hypersensitivity to latex.
- •History of Guillain Barré syndrome, or anaphylaxis.
- •Serious or unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of diary cards, attend regular phone calls/study site visits).
- •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Arms & Interventions
Co-Ad Group
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
Intervention: RSVPreF3 OA investigational vaccine
Co-Ad Group
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
Intervention: FLU HD vaccine
Control Group
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
Intervention: RSVPreF3 OA investigational vaccine
Control Group
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
Intervention: FLU HD vaccine
Outcomes
Primary Outcomes
RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
Time Frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
Time Frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.
RSV-B Neutralizing Titers Expressed as Group GMTs
Time Frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Secondary Outcomes
- HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT(At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups))
- HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains(At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups))
- HI Titers for 4 FLU Vaccine Strains, Expressed as MGI(At 1 month after the FLU vaccine dose administration (Day 31 for both groups))
- HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains(At 1 month after the FLU vaccine dose (Day 31 for both groups))
- Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration(Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31))
- RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)(At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group))
- RSV-B Neutralizing Titers Expressed as MGI(At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group))
- Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration(Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31))
- Percentage of Participants Reporting Unsolicited Adverse Events (AEs)(Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination))
- Percentage of Participants Reporting Serious Adverse Events (SAEs)(From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group))
- Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs)(From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group))