Trial · NCT07908654
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
NCT07908654, Phase 3, Not yet recruiting, Guangzhou Patronus Biotech Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older. Trials, record NCT07908654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908654
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
- NCT number
- NCT07908654
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 25,000 participants, estimated
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection, RSV Vaccine
- Interventions
- LYB005, Placebo
- First posted
- 2026-11-02
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) from 14 days post-vaccination through the end of the first RSV season | From 14 days post-vaccination through the end of the first RSV season | First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD from 14 days post-vaccination through the end of the first RSV 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. |
| Secondary | Immediate adverse events (AEs) within 30 minutes after vaccination | 30 mins after vaccination | The incidence, severity and causality of any AEs within 30 minutes after vaccination |
| Secondary | Solicited local and systemic AEs | Within 7 days after vaccination | The incidence, severity and causality of any solicited local and systemic AEs within 7 days after vaccination |
| Secondary | Unsolicited AEs | Within 30 days after vaccination | The incidence, severity and causality of any unsolicited AEs within 30 days after vaccination. |
| Secondary | Serious adverse events (SAEs) and adverse events of special interest (AESIs) | 12 months after vaccination | The incidence and causality of any SAEs and AESIs |
| Secondary | Incidence of first episode of RSV-associated severe LRTD (RSV-sLRTD) from 14 days post-vaccination through the end of the first RSV season | From 14 days post-vaccination through the end of the first RSV season | RT-PCR-confirmed RSV A and/or RSV B-sLRTD is assessed. |
| Secondary | Incidence of first episode of RT-PCR confirmed RSV A and/or B associated acute respiratory infections (ARI) from 14 days post-vaccination through the end of the first RSV season | From 14 days post-vaccination through the end of the first RSV season | RT-PCR-confirmed RSV A and/or RSV B-ARI is assessed. |
| Secondary | The geometric mean titer (GMT) of Neutralizing Antibodies against RSV A and RSV B | Before vaccination, 14 days, 30 days, 12 months and 24 months after vaccination | Measured by microneutralization assay. |
| Secondary | Geometric mean fold rise (GMFR) for Neutralizing Antibodies against RSV A and RSV B | 14 days, 30 days, 12 months and 24 months after vaccination | Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer against RSV A and RSV B |
| Secondary | The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies | Before vaccination, 14 days, 30 days, 12 months and 24 months after vaccination | Measured by Enzyme-Linked Immunosorbent Assay (ELISA). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908654
GET https://conductscience.org/api/trials/v1/NCT07908654/registered