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NCT00205803 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Pneumococcal Vaccine in Healthy Infants
A Phase 1 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 249
- Enrollment target
NCT00205803: Completed Phase 1 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00205803 is a Phase 1 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 249 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (315% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00205803, a Phase 1 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 249 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Primary Outcome
Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category.
Interventions
- BIOLOGICAL 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
- BIOLOGICAL 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-05 |
| Phase | Phase 1 |
What the finished NCT00205803 record still lists
NCT00205803 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (315% higher).
The record links to 0 conditions, and to 2 interventions - of which 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) is the first listed.
NCT00205803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00205803 about?
NCT00205803 is a clinical study titled "Study Evaluating Pneumococcal Vaccine in Healthy Infants". The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
What is the current status of trial NCT00205803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 249 participants. The study started on 2004-09. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00205803?
The interventions under investigation include: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) (BIOLOGICAL), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00205803?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00205803's enrollment target sits among peer trials
249 185th of 2000 higher than 1,816 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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