A Phase 3, Open-label, Randomized, Controlled Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-Administered With a COVID-19 mRNA Vaccine (Omicron XBB.1.5) in Adults Aged 50 Years and Above
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 841
- Locations
- 1
- Primary Endpoint
- Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- •Note: In case of physical incapacity that would preclude the self-completion of the diary cards, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time will the site staff or caregiver evaluate the participant's health status while answering diaries or make decisions on behalf of the participant.
- •Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
- •A male/female of ≥50 Years of age (YOA) at the time of the first study intervention administration.
- •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, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
- •A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- •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.
- •Participants who have received previously a SARS-CoV-2 vaccine, being administered at least 3 months prior to study vaccination.
- •Female participants of non-childbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
- •Female participants of childbearing potential may be enrolled in the study if the participant.
Exclusion Criteria
- •Medical Conditions
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including a known history of severe allergic reaction (e.g., anaphylaxis).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- •Any history of myocarditis or pericarditis.
- •Recurrent history or uncontrolled 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).
- •Serious or unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end).
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Any SAE attributed to a previous dose of the SARS-CoV-2 mRNA vaccine.
Arms & Interventions
Co-Ad Group
Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms.
Intervention: RSVPreF3 OA investigational vaccine
Co-Ad Group
Participants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms.
Intervention: COVID-19 mRNA vaccine
Control Group
Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31.
Intervention: RSVPreF3 OA investigational vaccine
Control Group
Participants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31.
Intervention: COVID-19 mRNA vaccine
Outcomes
Primary Outcomes
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
Time Frame: At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group)
RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.
Adjusted GMTs of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
Time Frame: At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group)
RSV-B neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.
Adjusted GMTs of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After the COVID-19 mRNA Vaccination
Time Frame: At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31 for both groups)
SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein were provided as group GMTs and expressed as titers. The neutralizing titer was calculated as the reciprocal serum dilution corresponding to the 50% signal reduction (NT50). Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.
Secondary Outcomes
- Number of Participants Reporting Any Serious Adverse Events (SAEs)(Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-Ad Group and Day 31 for Control Group]))
- RSV-A Neutralizing Titers Expressed as GMT at 1 Month After RSVPreF3 OA Vaccination(At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group))
- Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After RSVPreF3 OA Vaccination(At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group))
- RSV-A Neutralizing Titers Expressed as Seroresponse Rate (SRR) at 1 Month After RSVPreF3 OA Vaccination(At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group))
- Percentage of Participants Having RSV-A Neutralizing Titers Greater or Equal to the Assay Cut-off Value at Pre-vaccination and at 1 Month After RSVPreF3 OA Vaccination(At pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) and at 1 month post-RSVPreF3 OA vaccine dose administration (Day 31 for Co-Ad Group and Day 61 for Control Group))
- RSV-B Neutralizing Titers Expressed as GMT at 1 Month After RSVPreF3 OA Vaccination(At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group))
- MGI of RSV-B Neutralizing Titers at 1 Month After RSVPreF3 OA Vaccination(At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group))
- RSV-B Neutralizing Titers Expressed as SRR at 1 Month After RSVPreF3 OA Vaccination(At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group) compared to pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group))
- Percentage of Participants Having RSV-B Neutralizing Titers Greater or Equal to Assay Cut-off Value at Pre-vaccination and at 1 Month After RSVPreF3 OA Vaccination(At pre-vaccination (Day 1 for Co-Ad Group and Day 31 for Control Group) and at 1 month post-RSVPreF3 OA vaccine dose administration (Day 31 for Co-Ad Group and Day 61 for Control Group))
- SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers Expressed as GMT at 1 Month After COVID-19 mRNA Vaccination(At 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups))
- MGI of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After COVID-19 mRNA Vaccination(At 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups) compared to pre-vaccination (at Day 1 for both groups))
- Percentage of Participants Having SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers Greater Than or Equal to Assay Cut-off Value at Pre-vaccination and at 1 Month After COVID-19 mRNA Vaccination(At pre-vaccination (Day 1 for both groups) and at 1 month post-COVID-19 mRNA vaccine dose administration (Day 31 for both groups))
- Number of Participants Reporting Each Solicited Administration Site Event, for Each Type of Vaccine Administered(Within 4 days (the day of administration and 3 subsequent days) after each type of vaccine (RSVPreF3 OA vaccine administered at Day 1 for Co-Ad Group and at Day 31 for Control Group, COVID-19 mRNA vaccine administered at Day 1 for both groups))
- Number of Participants Reporting Each Solicited Systemic Event, for Each Day of Dose Administered(Within 4 days (the day of dose administered and 3 subsequent days) after each dose (administered at Day 1 for Co-Ad Group and at Days 1 and 31 for Control Group))
- Number of Participants Reporting Unsolicited Adverse Events (AEs), for Each Day of Dose Administered(Within 30 days (the day of vaccination and 29 subsequent days) after each dose (dose administered at Day 1 for Co-Ad Group and at Days 1 and 31 for Control Group))
- Number of Participants Reporting Any Potential Immune-mediated Diseases (pIMDs)(Throughout the study period (from Day 1 up to 6 months after the last dose administration [last dose given at Day 1 for Co-Ad Group and Day 31 for Control Group]))