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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Meningococcal Vaccines; Vaccines

Treatments: Biological: Gardasil; Biological: rLP2086 and Gardasil; Biological: rLP2086

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461993

6108A1-2007 (Other Identifier)

B1971011

Details and patient eligibility

About

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.

Enrollment: 2,499 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects from 11 to 17 years old at the time of they start the study.
• Subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator.

Exclusion criteria

• Previous vaccination with any meningococcal serogroup B vaccine.
• Previous vaccination with any HPV vaccine.
• Contraindication to vaccination with Gardasil or any HPV vaccine.

Trial design

2,499 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

rLP2086 + Gardasil

Treatment:

Biological: rLP2086 and Gardasil

Group 2

Placebo Comparator group

Description:

rLP2086 and saline

Treatment:

Biological: rLP2086

Group 3

Active Comparator group

Description:

Saline + Gardasil

Treatment:

Biological: Gardasil