CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 698 enrolled
Drug / intervention
bivalent rLP2086 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01543087
NCT01543087Phase 3Completed
CompareCT.gov

A PHASE 3 STUDY TO ASSESS THE PERSISTENCE OF HSBA RESPONSE UP TO 48 MONTHS AFTER COMPLETION OF A PRIMARY SERIES OF BIVALENT RLP2086, AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086

Pfizer·interventional·Posted Mar 2, 2012·Updated Mar 27, 2020

In Brief

A Phase 3 clinical trial evaluating blood sampling and bivalent rLP2086 for Meningococcal Infection. Completed, enrolled 698 participants across 56 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infection
CountriesCzechia, Denmark, Finland, Germany, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2012
Enrollment StartSep 7, 2012
Primary CompletionJan 5, 2018
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14.3 years ago

Interventions

blood samplingprocedure

Blood sample collection at different time points

bivalent rLP2086drug

A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.