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NCT00958243 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
A Phase 2 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 2
- Development phase
- 473
- Enrollment target
NCT00958243: Completed Phase 2 study, sponsored by Seqirus.
NCT00958243 is a Phase 2 study that has completed, run by Seqirus. The registered enrollment target is 473 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00958243, a Phase 2 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 473 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
Primary Outcome
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 473 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00958243 record still lists
NCT00958243 is an interventional study that assigns participants to a tested intervention. The registered 473 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00958243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00958243 about?
NCT00958243 is a clinical study titled "A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA". The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
What is the current status of trial NCT00958243?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 473 participants. The study started on 2009-08. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00958243?
The interventions under investigation include: Placebo (BIOLOGICAL), CSL's 2009 H1N1 Influenza Vaccine (CSL425) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00958243?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00958243's enrollment target sits among peer trials
473 78th of 2000 higher than 1,923 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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