NCT01299480

A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens 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 Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,714 (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 well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

Conditions

• Meningococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine	rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
BIOLOGICAL	Vaccine	rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
BIOLOGICAL	Vaccine	rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
BIOLOGICAL	Vaccine	rLP2086 at visits 1 and 3, saline at visits 2 and 5
BIOLOGICAL	Vaccine	rLP2086 at visits 3 and 5, saline at visits 1 and 2

Timeline

• Start date: 2011-03-03
• Primary completion: 2012-05-03
• Completion: 2012-09-18
• First posted: 2011-02-18
• Last updated: 2022-10-27
• Results posted: 2015-06-04

Locations

63 sites across 7 countries: Czechia, Denmark, Finland, Germany, Poland, Spain, Sweden