NCT01543087

Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is to assess the longevity of immune responses in adolescents (aged 10 to \<19 years at the time of entry into a primary study) following receipt of a vaccination regimen of 2 or 3 doses of bivalent rLP2086 in a primary study. A booster dose of bivalent rLP2086 at approximately 48 months was given following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series. The study was therefore divided into Stage 1 (4-year persistence of immune responses following receipt of a primary vaccination series) and the booster stage (follow-up through 12 months for all boosted or 26 months for a subset of the boosted). Subjects participating only in Stage 1 will attend up to 6 study visits for collection of a 20-mL blood sample at each visit. Subjects participating in both Stage 1 and booster stage will attend up to 9-10 study visits with 1 visit for booster dose vaccination and 8-9 visits for collection of a 20-mL blood sample at each visit.

Conditions

• Meningococcal Infection

Interventions

Type	Name	Description
PROCEDURE	blood sampling	Blood sample collection at different time points
DRUG	bivalent rLP2086	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.

Timeline

• Start date: 2012-09-07
• Primary completion: 2018-01-05
• Completion: 2018-01-05
• First posted: 2012-03-02
• Last updated: 2020-03-27
• Results posted: 2020-03-27

Locations

56 sites across 6 countries: United States, Czechia, Denmark, Finland, Germany, Sweden

Regulatory

• FDA-regulated drug study