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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

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Coastal Clinical Research Inc.
Daphne, Alabama, 36526 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Meningococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous vaccination with any meningococcal serogroup B vaccine.

- Previous vaccination with any HPV vaccine.

- Contraindication to vaccination with Gardasil or any HPV vaccine.

NCT01461993
Pfizer
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

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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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Vaccines
  • Meningococcal Vaccines
  • 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.
  • Active Comparator: Group 1
    rLP2086 + Gardasil
    Intervention: Biological: rLP2086 and Gardasil
  • Placebo Comparator: Group 2
    rLP2086 and saline
    Intervention: Biological: rLP2086
  • Active Comparator: Group 3
    Saline + Gardasil
    Intervention: Biological: Gardasil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2499
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
11 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01461993
B1971011
6108A1-2007 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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