A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 751
- Locations
- 1
- Primary Endpoint
- RSV-A neutralizing titers expressed as GMTs
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
- •Specific inclusion criteria for all participants in Cohort 1 (Older adults)
- •Male or female, \>= 60 YOA at the time of the study intervention administration.
- •Participants who are medically stable in the opinion of the investigator at the time of study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
- •Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
- •Specific inclusion criteria for all participants in Cohort 2 (Adults-AIR)
- •Male or female, 50-59 YOA at the time of the study intervention administration.
- •Participants should be diagnosed with at least 1 of the following medical conditions and considered medically stable by the investigator:
- •Chronic pulmonary disease resulting in activity restricting symptoms or use of long term medication:
Exclusion Criteria
- •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, 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).
- •Unstable chronic illness.
- •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 the eDiary, attend phone call/study site visits).
- •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).
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •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
Arms & Interventions
OA-RSV group
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention: RSVPreF3 OA investigational vaccine
OA-Placebo group
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
Intervention: Placebo
Adults-AIR-RSV group
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention: RSVPreF3 OA investigational vaccine
Adults-AIR-Placebo group
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
Intervention: Placebo
Outcomes
Primary Outcomes
RSV-A neutralizing titers expressed as GMTs
Time Frame: At Day 31 (1 month post-study intervention administration)
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
RSV-B neutralizing titers expressed as GMTs
Time Frame: At Day 31 (1 month post-study intervention administration)
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs)
Time Frame: At Day 1 (pre-study intervention administration)
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
Secondary Outcomes
- Number of participants reporting any solicited administration site events(Day 1 (day of administration) to Day 4)
- Number of participants reporting any solicited systemic events(Day 1 (day of administration) to Day 4)
- Number of participants reporting any unsolicited AEs(Day 1 to Day 30)
- Number of participants reporting any serious adverse events (SAEs)(From Day 1 up to data lock point of primary analysis (median follow-up: 176 days))
- Number of participants reporting any SAEs(From Day 1 up to study end (approximately 6 months post study intervention administration))
- Number of participants reporting any pIMDs(From Day 1 up to study end (approximately 6 months post study intervention administration))