A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older
Overview
- Phase
- Phase 3
- Intervention
- RSVPreF3 OA investigational vaccine
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 2621
- Locations
- 39
- Primary Endpoint
- RSV-A neutralization titers expressed as geometric mean titers (GMTs) in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group GMT ratios
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants).
- •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, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications).
- •Participants who are medically stable in the opinion of the investigator at the time of 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.
- •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.
Exclusion Criteria
- •Medical Conditions:
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- •Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants).
- •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 dementia or any medical condition that moderately or severely impairs cognition.
- •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 diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only).
- •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 to less than 1 year).
- •Serious or unstable chronic illness.
- •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
RSV OA vaccine Group (China)
Chinese participants receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (Month 6 or last ARI visit/contact, whichever is later).
Intervention: RSVPreF3 OA investigational vaccine
Placebo Group (China)
Chinese participants receive a single dose of placebo at Day 1 and are followed up until end of study (Month 6 or last ARI visit/contact, whichever is later).
Intervention: Placebo
RSV OA vaccine Group (Overseas)
Overseas participants receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (Month 6).
Intervention: RSVPreF3 OA investigational vaccine
Outcomes
Primary Outcomes
RSV-A neutralization titers expressed as geometric mean titers (GMTs) in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group GMT ratios
Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
RSV-A neutralization titers are determined by neutralization assay and expressed as GMTs.
Percentage of participants showing group seroresponse for RSV-A in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group differences
Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
A participant with seroresponse for RSV-A is defined as a participant having at least a 4-fold increase in RSV-A neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4).
RSV-B neutralization titers expressed as geometric mean titers (GMTs) in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group GMT ratios)
Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
RSV-B neutralization titers are determined by neutralization assay and expressed as GMTs.
Percentage of participants showing group seroresponse for RSV-B in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China), and between-group differences
Time Frame: At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
A participant with seroresponse for RSV-B is defined as a participant having at least a 4-fold increase in RSV-B neutralizing titers (1 month post-study intervention administration over pre-study intervention administration \>=4).
Secondary Outcomes
- RSV-A neutralization titers expressed as group GMTs in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China)(At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31))
- Percentage of participants showing seroresponse for RSV-B in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China)(At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31))
- Number of participants with solicited administration site events in RSV OA Group (China) and Placebo Group (China)(Within 7 days after study intervention administration (the day of study intervention administration and the subsequent 6 days))
- Number of participants with serious adverse events (SAEs) in all study groups(From the study intervention administration (Day 1) to Month 6)
- Percentage of participants showing seroresponse for RSV-A in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)(At 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration)
- RSV-A neutralization titers expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)(At Baseline (Day 1), at 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration)
- RSV-B neutralization titers expressed as group GMTs in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China)(At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31))
- Number of participants with pIMDs related to study interventions in all study groups(From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration))
- Percentage of participants showing seroresponse for RSV-B in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)(At 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration)
- Percentage of participants showing seroresponse for RSV-A in the immunogenicity subset of RSV OA=ADJ-006 study and in RSV OA vaccine Group (China)(At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31))
- Number of participants with real time polymerase chain reaction (RT-PCR) confirmed RSV-A associated ARI and LRTD in RSV OA vaccine Group (China) and Placebo Group (China)(From the RSVPreF3 OA investigational vaccine administration (Day 1) to Month 6)
- Number of participants with RT-PCR confirmed RSV-B associated ARI and LRTD RSV OA vaccine Group (China) and Placebo Group (China)(From the RSVPreF3 OA investigational vaccine administration (Day 1) to Month 6)
- Number of participants with solicited systemic events in RSV OA Group (China) and Placebo Group (China)(Within 7 days after study interventions (the day of study intervention administration and the subsequent 6 days))
- Number of participants with unsolicited adverse events (AEs) in RSV OA Group (China) and Placebo Group (China)(Within 30 days after study interventions (the day of study intervention administration and the subsequent 29 days))
- Number of participants with any fatal SAEs in all study groups(From the RSVPreF3 OA investigational vaccine administration (Day 1) to study end (approximately 6 months post dose administration))
- RSV-B neutralization titres expressed as GMTs in RSV OA vaccine Group (Overseas) and RSV OA vaccine Group (China)(At Baseline (Day 1), at 1 month (Day 31) and at 6 months (Day 181) after the RSVPreF3 OA investigational vaccine administration)
- Number of participants with potential immune-mediated disease (pIMDs) in all study groups(From the study intervention administration (Day 1) to Month 6)
- Number of participants with SAEs related to study intervention in all study groups(From the study intervention administration (Day 1) to study end (approximately 6 months post dose administration))