Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07220109 | A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease | PHASE3 | RECRUITING | 750 | — | — | Oct 29, 2025 | Mar 12, 2027 | May 27, 2026 | 15 | China |
| NCT06534892 | An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study | PHASE3 | ACTIVE NOT_RECRUITING | 10,212 | — | — | Aug 1, 2024 | Sep 30, 2026 | May 27, 2026 | 249 | United States, Australia +15 |
| NCT05568797 | A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above | PHASE3 | COMPLETED | 1,045 | — | — | Oct 14, 2022 | Jul 17, 2023 | Sep 24, 2024 | 37 | Belgium, Finland +3 |
| NCT04886596 | Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above | PHASE3 | COMPLETED | 26,675 | — | — | May 25, 2021 | May 31, 2024 | Jul 31, 2025 | 277 | United States, Australia +15 |
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...