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NCT01543087 · ClinicalTrials.gov registry record · Phase 3
Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 698
- Enrollment target
NCT01543087: Completed Phase 3 study, sponsored by Pfizer.
NCT01543087 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 698 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01543087, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 698 participants
- Enrollment target
Study Summary
This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.
Primary Outcome
For immunogenicity assessment, serum bactericidal assay using human complement (hSBA) was performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains. Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants who received bivalent rLP2086 in primary study B1971012, entered in this study at
Interventions
- PROCEDURE blood sampling
- DRUG bivalent rLP2086
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2012-09-07 |
| Est. Completion | 2018-01-05 |
| Phase | Phase 3 |
What the finished NCT01543087 record still lists
NCT01543087 is an interventional study that assigns participants to a tested intervention. The registered 698 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 (10% lower).
The record links to 0 conditions, and to 2 interventions - of which blood sampling is the first listed.
NCT01543087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01543087 about?
NCT01543087 is a clinical study titled "Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose". This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.
What is the current status of trial NCT01543087?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 698 participants. The study started on 2012-09-07. Estimated completion is 2018-01-05.
What interventions are being tested in trial NCT01543087?
The interventions under investigation include: blood sampling (PROCEDURE), bivalent rLP2086 (DRUG).
Who is sponsoring clinical trial NCT01543087?
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 NCT01543087's enrollment target sits among peer trials
698 516th of 2000 higher than 1,483 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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