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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Human Papillomavirus Infection

Treatments

Biological: Comparator: Menactra™ (Concomitant)

Biological: Comparator: Menactra™ (Non-Concomitant)

Biological: V503

Biological: Comparator: Adacel™ (Non-concomitant)

Biological: Comparator: Adacel™ (Concomitant)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00988884

V503-005

Details and patient eligibility

About

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™.

Enrollment

1,241 patients

Sex

All

Ages

11 to 15 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,241 participants in 2 patient groups

Concomitant Vaccination

Experimental group

Description:

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

Treatment:

Biological: Comparator: Adacel™ (Concomitant)

Biological: Comparator: Menactra™ (Concomitant)

Biological: V503

Non-concomitant Vaccination

Experimental group

Description:

Treatment:

Biological: Comparator: Menactra™ (Non-Concomitant)

Biological: Comparator: Adacel™ (Non-concomitant)

Biological: V503