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NCT00616421 · ClinicalTrials.gov registry record · Phase 3
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,907
- Enrollment target
NCT00616421: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT00616421 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 2,907 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (277% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616421, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,907 participants
- Enrollment target
Study Summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Primary Outcome
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 t
Interventions
- BIOLOGICAL MenACWY-CRM
- BIOLOGICAL Licensed meningococcal ACWY vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,907 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00616421 record still lists
NCT00616421 is an interventional study that assigns participants to a tested intervention. Its 2,907 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 (277% higher).
The record links to 0 conditions, and to 2 interventions - of which MenACWY-CRM is the first listed.
NCT00616421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616421 about?
NCT00616421 is a clinical study titled "Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children". To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
What is the current status of trial NCT00616421?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,907 participants. The study started on 2008-03. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00616421?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL), Licensed meningococcal ACWY vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00616421?
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 NCT00616421's enrollment target sits among peer trials
2,907 80th of 2000 higher than 1,921 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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