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NCT01682876 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 715
- Enrollment target
NCT01682876: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01682876 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 715 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
NCT01682876, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 715 participants
- Enrollment target
Study Summary
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
Primary Outcome
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with
Interventions
- BIOLOGICAL MenACWY-CRM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2012-10-07 |
| Est. Completion | 2014-05-30 |
| Phase | Phase 3 |
What the finished NCT01682876 record still lists
NCT01682876 is an interventional study that assigns participants to a tested intervention. The registered 715 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 1 intervention - of which MenACWY-CRM is the first listed.
NCT01682876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01682876 about?
NCT01682876 is a clinical study titled "Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.". This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
What is the current status of trial NCT01682876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 715 participants. The study started on 2012-10-07. Estimated completion is 2014-05-30.
What interventions are being tested in trial NCT01682876?
The interventions under investigation include: MenACWY-CRM (BIOLOGICAL).
Who is sponsoring clinical trial NCT01682876?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01682876's enrollment target sits among peer trials
715 498th of 2000 higher than 1,503 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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