A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1459
- Locations
- 1
- Primary Endpoint
- Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).
- •Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
- •Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure.
- •Specific inclusion criteria for all participants in Cohort 1 and Cohort 3 (RSV-A-AIR Group) • A male or female participant 18-49 YOA at the time of the study intervention administration.
- •Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator:
- •Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication:
- •o Chronic obstructive pulmonary disease (COPD)
- •o Cystic fibrosis
- •o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis
- •o Chronic heart failure:
Exclusion Criteria
- •Medical conditions
- •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).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- •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 (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures.
- •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
Part A: RSV-A-AIR Group
Adult (A) participants, 18-49 YOA, at increased risk (AIR) for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.
Intervention: RSVPreF3 OA investigational vaccine
Part A: RSV-OA Group
Older adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention: RSVPreF3 OA investigational vaccine
Part B: RSV-A-AIR Group
Adult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Intervention: RSVPreF3 OA investigational vaccine
Outcomes
Primary Outcomes
Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
Time Frame: At Day 31
RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)
Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers
Time Frame: Day 31 compared with baseline (Day 1)
SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.
Part A: RSV-B Neutralizing Titers Expressed as Group GMTs
Time Frame: At Day 31
RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.
Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers
Time Frame: Day 31 compared with baseline (Day 1)
SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.
Secondary Outcomes
- Part A and B: Number of Participants Reporting Any Solicited Systemic Events(Day 1 (post dose) to Day 4)
- Part A and B: Number of Participants Reporting Unsolicited Adverse Events (AEs)(Day 1 (post dose) to Day 30)
- Part A and B: Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs(Throughout the study period (Day 1 to Month 6))
- Part A and B: Number of Participants Reporting Any Adverse Events of Special Interest (AESIs)(Throughout the study period (Day 1 to Month 6))
- Part A: RSV-A Neutralizing Titers Expressed as GMTs(At Day 1 (pre-dose), at Month 1 and Month 6)
- Part A: RSV-B Neutralizing Titers Expressed as GMTs(At Day 1 (pre-dose), at Month 1 and Month 6)
- Part A and B: Number of Participants Reporting Any Solicited Administration Site Events(Day 1 (post dose) to Day 4)