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NCT01000311 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
NCT01000311: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT01000311 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 529 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01000311, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
Study Summary
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
Primary Outcome
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccinati
Interventions
- BIOLOGICAL MenACWY-CRM
- BIOLOGICAL DTaP-IPV/Hib
- BIOLOGICAL HBV
- BIOLOGICAL PCV
- BIOLOGICAL MMR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01000311 record still lists
NCT01000311 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 5 interventions - of which MenACWY-CRM is the first listed.
NCT01000311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01000311 about?
NCT01000311 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months". This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
What is the current status of trial NCT01000311?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2009-11. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01000311?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL), DTaP-IPV/Hib (BIOLOGICAL), HBV (BIOLOGICAL), PCV (BIOLOGICAL), MMR (BIOLOGICAL).
Who is sponsoring clinical trial NCT01000311?
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 NCT01000311's enrollment target sits among peer trials
529 709th of 2000 higher than 1,290 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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