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

Phase 2

Completed

• Conditions: Meningococcal Vaccines; Vaccines

• Registration Number: NCT01461993
• Lead Sponsor: Pfizer

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2013-07-06
• Study Completion: 2013-07-06
• Disposition First Submitted: 2014-07-25
• Disposition First Submitted QC: 2014-07-25
• Disposition First Posted: 2014-07-30
• Results First Submitted: 2014-11-21
• Results First Submitted QC: 2014-11-21
• Results First Posted: 2014-11-26
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2499

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens	1 month after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]	1 month after Vaccination 3
Percentage of Participants With at Least One Adverse Event (AE)	Vaccination 1 up to 1 month after Vaccination 3

Secondary Outcome Measures

Name	Time	Method
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	Before vaccination 1
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	1 month after Vaccination 3
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Before vaccination 1, 1 month after vaccination (Vac) 2, 3
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level	Before Vaccination 1, 1 month after Vaccination 2, 3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)	Before Vaccination 1, 1 month after Vaccination 2, 3

Trial Locations

Locations (78)

Coastal Clinical Research Inc.; 🇺🇸 Daphne, Alabama, United States

Radiant Research, Inc.; 🇺🇸 San Antonio, Texas, United States

The Children's Clinic of Jonesboro, PA; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Pediatric Clinic; 🇺🇸 Little Rock, Arkansas, United States

West Coast Clinical Trials, LLC; 🇺🇸 Cypress, California, United States

Pediatric Care Medical Group; 🇺🇸 Huntington Beach, California, United States

Loma Linda University Health Care - Moreno Valley Pediatrics; 🇺🇸 Moreno Valley, California, United States

Bayview Research Group, LLC; 🇺🇸 Valley Village, California, United States

Center for Clinical Trials, LLC; 🇺🇸 Paramount, California, United States

California Research Foundation; 🇺🇸 San Diego, California, United States

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