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NCT03135834 · ClinicalTrials.gov registry record · Phase 3
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,610
- Enrollment target
NCT03135834: Completed Phase 3 study, sponsored by Pfizer.
NCT03135834 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,610 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (109% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03135834, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,610 participants
- Enrollment target
Study Summary
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
Primary Outcome
Percentage of participants who achieved an hSBA titer \>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.
Interventions
- BIOLOGICAL Saline
- BIOLOGICAL MenACWY-CRM
- BIOLOGICAL MenABCWY
- BIOLOGICAL rLP2086
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,610 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2022-10-25 |
| Phase | Phase 3 |
What the finished NCT03135834 record still lists
NCT03135834 is an interventional study that assigns participants to a tested intervention. Its 1,610 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 (109% higher).
The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.
NCT03135834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03135834 about?
NCT03135834 is a clinical study titled "A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.". This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
What is the current status of trial NCT03135834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,610 participants. The study started on 2017-04-24. Estimated completion is 2022-10-25.
What interventions are being tested in trial NCT03135834?
The interventions under investigation include: Saline (BIOLOGICAL), MenACWY-CRM (BIOLOGICAL), MenABCWY (BIOLOGICAL), rLP2086 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03135834?
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 NCT03135834's enrollment target sits among peer trials
1,610 142nd of 2000 higher than 1,859 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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