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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Papillomavirus Infections

Treatments: Biological: REPEVAX™ (Non-concomitant); Biological: V503 Vaccine; Biological: REPEVAX™ (Concomitant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01073293

2010_512 (Other Grant/Funding Number)

V503-007

Details and patient eligibility

About

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.

Enrollment: 1,054 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,054 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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1

Treatment:

Biological: V503 Vaccine

Biological: REPEVAX™ (Concomitant)

Non-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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Treatment:

Biological: REPEVAX™ (Non-concomitant)

Biological: V503 Vaccine