A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-21

Study Completion Date

2011-02-22

Brief Summary

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This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.

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Detailed Description

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Conditions

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Human Papillomavirus Infection

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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1

Group Type EXPERIMENTAL

V503

Intervention Type BIOLOGICAL

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6

Comparator: Menactra™ (Concomitant)

Intervention Type BIOLOGICAL

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Comparator: Adacel™ (Concomitant)

Intervention Type BIOLOGICAL

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on 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 Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Group Type EXPERIMENTAL

V503

Intervention Type BIOLOGICAL

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6

Comparator: Menactra™ (Non-Concomitant)

Intervention Type BIOLOGICAL

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Comparator: Adacel™ (Non-concomitant)

Intervention Type BIOLOGICAL

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Interventions

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V503

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6

Intervention Type BIOLOGICAL

Comparator: Menactra™ (Concomitant)

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Intervention Type BIOLOGICAL

Comparator: Adacel™ (Concomitant)

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Intervention Type BIOLOGICAL

Comparator: Menactra™ (Non-Concomitant)

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Intervention Type BIOLOGICAL

Comparator: Adacel™ (Non-concomitant)

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject is in good health
* Subject's parent/legal guardian can read, understand, and complete the vaccine report card
* Subject is not sexually active and does not plan on becoming sexually active during the study
* Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)

Exclusion Criteria

* Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
* Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
* Subject has any coagulation disorder
* Female subject is pregnant
* Subject is immunocompromised or immunodeficient
* Subject has had a splenectomy
* Subject has received immunosuppressive therapies in the prior year
* Subject has received any immune globulin product or blood-derived product in the last 3 months
* Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
* Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
* Subject has received a meningococcal vaccine
* Subject has a fever \>= 100F within 24 hours of vaccination
* Subject has a history of HPV

Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes