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NCT00626327 · ClinicalTrials.gov registry record · Phase 3
Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,630
- Enrollment target
NCT00626327: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT00626327 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 1,630 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626327, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,630 participants
- Enrollment target
Study Summary
Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers
Primary Outcome
Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported. Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5
Interventions
- BIOLOGICAL MenACWY-CRM
- BIOLOGICAL MMRV
- BIOLOGICAL MenACWY-CRM + MMRV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,630 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00626327 record still lists
NCT00626327 is an interventional study that assigns participants to a tested intervention. Its 1,630 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (111% higher).
The record links to 0 conditions, and to 3 interventions - of which MenACWY-CRM is the first listed.
NCT00626327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00626327 about?
NCT00626327 is a clinical study titled "Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers". Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers
What is the current status of trial NCT00626327?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,630 participants. The study started on 2008-02. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00626327?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL), MMRV (BIOLOGICAL), MenACWY-CRM + MMRV (BIOLOGICAL).
Who is sponsoring clinical trial NCT00626327?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00626327's enrollment target sits among peer trials
1,630 141st of 2000 higher than 1,860 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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