Trial · NCT07908654
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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). |
| Secondary | GMFR for Pre-fusion Protein Specific Binding Antibodies | 14 days, 30 days, 12 months and 24 months after vaccination | Change from prevaccination in geometric mean fold rise of Pre-fusion Protein Specific Binding Antibodies |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07908654/registered