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NCT06134804 · ClinicalTrials.gov registry record · Phase 3
A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 959
- Enrollment target
NCT06134804: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT06134804 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 959 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06134804, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 959 participants
- Enrollment target
Study Summary
The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.
Primary Outcome
HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ExPEC9V
- BIOLOGICAL HD quadrivalent influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 959 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 3 |
What the finished NCT06134804 record still lists
NCT06134804 is an interventional study that assigns participants to a tested intervention. The registered 959 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06134804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06134804 about?
NCT06134804 is a clinical study titled "A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older". The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD Q...
What is the current status of trial NCT06134804?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 959 participants. The study started on 2023-10-24. Estimated completion is 2024-07-26.
What interventions are being tested in trial NCT06134804?
The interventions under investigation include: Placebo (BIOLOGICAL), ExPEC9V (BIOLOGICAL), HD quadrivalent influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06134804?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06134804's enrollment target sits among peer trials
959 332nd of 2000 higher than 1,669 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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