Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Vaccines
Meningococcal Vaccines
Eligibility:
All Genders
11-17 years
Phase:
PHASE2
Brief 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 int...
Eligibility Criteria
Inclusion
- 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
- Previous vaccination with any meningococcal serogroup B vaccine.
- Previous vaccination with any HPV vaccine.
- Contraindication to vaccination with Gardasil or any HPV vaccine.
Key Trial Info
Start Date :
September 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2013
Estimated Enrollment :
2499 Patients enrolled
Trial Details
Trial ID
NCT01461993
Start Date
September 28 2011
End Date
July 6 2013
Last Update
December 19 2018
Active Locations (87)
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1
Coastal Clinical Research Inc.
Daphne, Alabama, United States, 36526
2
Radiant Research, Inc.
Chandler, Arizona, United States, 85224
3
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States, 72401
4
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205