NCT01323270

A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Repevax(Registered) And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 753 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Conditions

• Meningococcal Vaccine
• rLP2086
• Repevax
• N Meningitidis Serogroup B
• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	rLP2086	0.5 mL dose, given at 0, 2 and 6 months.
BIOLOGICAL	Repevax	0.5 mL dose, given at 0 months.
BIOLOGICAL	Saline	0.5 mL dose, given at 0, 2 and 6 months.
BIOLOGICAL	Repevax	0.5 mL dose, given at 0 months.

Timeline

• Start date: 2011-03-18
• Primary completion: 2012-10-08
• Completion: 2013-02-19
• First posted: 2011-03-25
• Last updated: 2022-10-27
• Results posted: 2014-11-26

Locations

36 sites across 3 countries: Finland, Germany, Poland