Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01214837 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 751
- Enrollment target
NCT01214837: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT01214837 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 751 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01214837, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 751 participants
- Enrollment target
Study Summary
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
Primary Outcome
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
Interventions
- BIOLOGICAL MenACWY-CRM
- BIOLOGICAL Routine Vaccines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT01214837 record still lists
NCT01214837 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which MenACWY-CRM is the first listed.
NCT01214837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01214837 about?
NCT01214837 is a clinical study titled "Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life". The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
What is the current status of trial NCT01214837?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 751 participants. The study started on 2010-10. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01214837?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL), Routine Vaccines (BIOLOGICAL).
Who is sponsoring clinical trial NCT01214837?
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 NCT01214837's enrollment target sits among peer trials
751 462nd of 2000 higher than 1,537 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06559306 · 752 participants · Phase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
- NCT02048332 · 750 participants · Phase 1
Donor-Derived Viral Specific T-cells (VSTs)
- NCT02087852 · 750 participants
Kidney Cancer DNA Registry
- NCT02532452 · 750 participants · Phase 2
Third Party Viral Specific T-cells (VSTs)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia