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NCT01830855 · ClinicalTrials.gov registry record · Phase 3
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,596
- Enrollment target
NCT01830855: Completed Phase 3 study, sponsored by Pfizer.
NCT01830855 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 3,596 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (366% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01830855, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,596 participants
- Enrollment target
Study Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Primary Outcome
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies
Interventions
- BIOLOGICAL Saline
- BIOLOGICAL rLP2086
- BIOLOGICAL Havrix (HAV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,596 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01830855 record still lists
NCT01830855 is an interventional study that assigns participants to a tested intervention. Its 3,596 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 (366% higher).
The record links to 0 conditions, and to 3 interventions - of which Saline is the first listed.
NCT01830855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01830855 about?
NCT01830855 is a clinical study titled "A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years". This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
What is the current status of trial NCT01830855?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,596 participants. The study started on 2013-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01830855?
The interventions under investigation include: Saline (BIOLOGICAL), rLP2086 (BIOLOGICAL), Havrix (HAV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01830855?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01830855's enrollment target sits among peer trials
3,596 68th of 2000 higher than 1,933 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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