Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSVPreF3 OA vaccine · 4 trials · 1 indication
The serum neutralizing titers are expressed in Estimated Dilution (ED60). The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
The SRR is defined as the proportion of participants having a 4-fold increase in neutralizing titers. The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
The serum neutralizing titers are expressed in ED60. The group GMT ratio will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) over RSV AIR (from the current study).
The group SRR difference will be evaluated for RSV-OA overseas group (from RSV OA-ADJ-021 study) minus RSV AIR (from the current study).
HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains.
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).
RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60).
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
| Arm | Type | Description |
|---|---|---|
| RSV AIR group | EXPERIMENTAL | Participants at increased risk (AIR) of RSV disease will receive a single dose of investigational RSVPreF3 OA investigational vaccine on Visit 1 (Day 1). |
| Placebo AIR group | PLACEBO_COMPARATOR | Participants AIR of RSV disease will receive a single dose of Placebo on Visit 1 (Day 1). |
| RSV_PreS4 | EXPERIMENTAL | Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4. |
| RSV_PreS5 | EXPERIMENTAL | Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5. |
| RSV_1Dose | NO_INTERVENTION | Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine. |
| Crossover | EXPERIMENTAL | Participants in this group will receive a single dose of RSVPreF3 OA vaccine. |
| Co-Ad Group | EXPERIMENTAL | Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study. |
| Control Group | ACTIVE_COMPARATOR | Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study. |
| RSVPreF3 Group | EXPERIMENTAL | Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study. |
| Placebo Group | PLACEBO_COMPARATOR | Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study. |
| Name | Type | Description |
|---|---|---|
| RSVPreF3 OA vaccine | BIOLOGICAL | 1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm. |
| Placebo | BIOLOGICAL | 1 dose of saline solution administered intramuscularly in the deltoid region of the non-dominant arm. |
| FLU vaccine | BIOLOGICAL | One dose of FLU vaccine administered intramuscularly. |
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 stud...
RSVPreF3 OA vaccine is an investigational vaccine being studied for the prevention of Respiratory Syncytial Virus (RSV) infections in adults. It is being evaluated in adults aged 60 years and above, as well as in adults aged 18 to 59 years at increased risk of RSV disease. The vaccine is administered to generate an immune response against RSV.
RSVPreF3 OA vaccine targets the respiratory syncytial virus (RSV), specifically the RSV prefusion F protein. The vaccine is designed to elicit an immune response against this viral protein, which is essential for the virus to enter host cells. By targeting this protein, the vaccine aims to protect against RSV infection.
RSVPreF3 OA vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's efficacy, immune response, and safety in various adult populations.
RSVPreF3 OA vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 program includes multiple trials assessing the vaccine's efficacy, immunogenicity, and safety in adults aged 60 years and older, as well as in younger adults at increased risk.
RSVPreF3 OA vaccine is being studied in four Phase 3 clinical trials. NCT04886596 is a completed efficacy study in adults aged 60 years and above. NCT05568797 is a completed study on immune response and safety in adults aged 65 years and above. NCT06534892 is an active extension study in adults aged 60 years and above. NCT07220109 is an active study in Chinese adults aged 18 to 59 years at increased risk of RSV disease.
RSVPreF3 OA vaccine is the investigational name for GSK's respiratory syncytial virus vaccine candidate. It is also known as Arexvy in some contexts. The vaccine is being evaluated in clinical trials under the RSVPreF3 OA designation, and the same vaccine candidate has been studied under the brand name Arexvy.