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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01461993
First received: September 28, 2011
Last updated: November 21, 2014
Last verified: November 2014
  Purpose
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.

Condition Intervention Phase
Vaccines Meningococcal Vaccines Biological: rLP2086 and Gardasil Biological: rLP2086 Biological: Gardasil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Pfizer:

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

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

Enrollment: 2499
Study Start Date: September 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
rLP2086 + Gardasil
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.
Placebo Comparator: Group 2
rLP2086 and saline
Biological: rLP2086
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
Active Comparator: Group 3
Saline + Gardasil
Biological: Gardasil
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461993

  Show 90 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01461993     History of Changes
Other Study ID Numbers: B1971011
6108A1-2007 ( Other Identifier: Alias Study Number )
Study First Received: September 28, 2011
Results First Received: November 21, 2014
Last Updated: November 21, 2014

Keywords provided by Pfizer:
vaccine
rLP2086
Gardasil
HPV
meningitis B
N. meningitidis serogroup B
adolescents
single-blind
Meningococcal Vaccines

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017