A Phase III, Open-label, Randomized, Controlled, Multi-Country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co Administered With PCV20 in Adults Aged 60\xa0Years and Older
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1113
- Locations
- 1
- Primary Endpoint
- Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A male or female ≥60 years of age at the time of the first study intervention administration.
- •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written or witnessed informed consent obtained from the participant prior to any study-specific procedure being performed.
- •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 are medically stable in the opinion of the investigator at the time of first study intervention administration. 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
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by the study interventions, in particular any history of severe allergic reaction to any vaccine containing diphtheria toxoid, or pneumococcal polysaccharide 23-valent vaccine (PPSV23).
- •Participants considered by investigator as suffering from serious or unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely impairs cognition.
- •Recurrent 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.
- •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.
- •History of previous vaccination with any licensed or investigational pneumococcal conjugate vaccine, or planned receipt through study participation.
- •History of previous vaccination with any licensed or investigational pneumococcal polysaccharide vaccine in the last 5 years from enrollment, or planned receipt through study participation.
- •Previous vaccination with any licensed or investigational RSV vaccine
Arms & Interventions
Co-administration Group
Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.
Intervention: RSVPreF3 OA investigational vaccine
Co-administration Group
Participants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.
Intervention: PCV20
Control Group
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
Intervention: RSVPreF3 OA investigational vaccine
Control Group
Participants received PCV20 vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31.
Intervention: PCV20
Outcomes
Primary Outcomes
Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
Time Frame: At Day 31
The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
Time Frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.
Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
Time Frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.
Secondary Outcomes
- Number of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration(Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group))
- Number of Participants With Unsolicited AEs(Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group))
- MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination(At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group))
- Mean Geometric Increase (MGI) of RSV-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination(At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Day 31 for Control Group))
- Number of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration(Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for Co-Administration Group and at Days 1 and 31 for Control group))
- Number of Participants With 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-administration Group and Day 31 for Control Group]))
- Number of Participants With 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-administration Group and Day 31 for Control Group]))