NCT01461993

A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17

A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,499 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.

Conditions

• Vaccines
• Meningococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	rLP2086 and Gardasil	Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
BIOLOGICAL	rLP2086	Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
BIOLOGICAL	Gardasil	Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

Timeline

• Start date: 2011-09-28
• Primary completion: 2013-07-06
• Completion: 2013-07-06
• First posted: 2011-10-28
• Last updated: 2018-12-19
• Results posted: 2014-11-26

Locations

87 sites across 1 country: United States