A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1054 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-22

Study Completion Date

2011-06-16

Brief Summary

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This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.

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Detailed Description

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Conditions

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Papillomavirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Concomitant Vaccination

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1

Group Type EXPERIMENTAL

V503 Vaccine

Intervention Type BIOLOGICAL

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

REPEVAX™ (Concomitant)

Intervention Type BIOLOGICAL

REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1

Non-concomitant Vaccination

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Group Type EXPERIMENTAL

V503 Vaccine

Intervention Type BIOLOGICAL

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

REPEVAX™ (Non-concomitant)

Intervention Type BIOLOGICAL

REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

Interventions

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V503 Vaccine

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Intervention Type BIOLOGICAL

REPEVAX™ (Concomitant)

REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1

Intervention Type BIOLOGICAL

REPEVAX™ (Non-concomitant)

REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participant is in good health
* Participant's parent/legal guardian can read, understand, and complete the vaccination report card
* Participant is not sexually active and does not plan on becoming sexually active during the study
* Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.

Exclusion Criteria

* Participant has a known allergy to any vaccine component of V503 or REPEVAX™
* Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine
* Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine
* Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine
* Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™
* Participant has a history of severe allergic reaction that required medical intervention
* Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections
* Participant is concurrently enrolled in clinical studies of investigational agents
* Female participant is pregnant
* Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study
* Participant is immunocompromised, immunodeficient, or has an autoimmune condition
* Participant has had a splenectomy
* Participant has received immunosuppressive therapies in the prior year
* Participant has received immune globulin product or blood-derived product in the last 3 months
* Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination
* Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial
* Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years
* Participant has a fever ≥100°F within 24 hours of vaccination
* Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate
* Participant and parent/legal guardian are unable to give assent/consent
* Participant is unlikely to adhere to the study procedures or is planning to relocate during the study
* Participant has recent history of illicit drug or alcohol abuse
* Participant has a history of HPV

Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes