A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007 AM1) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Papillomavirus Infections	Biological: V503 Vaccine Biological: REPEVAX™ (Concomitant) Biological: REPEVAX™ (Non-concomitant)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

Further study details as provided by Merck:

Primary Outcome Measures:

Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 [ Time Frame: 4 weeks post-dose 3 of V503 ] [ Designated as safety issue: No ]
Number of participants reporting injection site adverse experiences [ Time Frame: Day 1 to Day 5 following Day 1 V503 administration ] [ Designated as safety issue: Yes ]
Number of participants reporting injection site adverse experiences [ Time Frame: Day 1 to Day 5 following Day 1/Month 1 REPEVAX™ administration ] [ Designated as safety issue: Yes ]
Number of participants reporting elevated temperatures [ Time Frame: Day 1 to Day 5 post Day 1/Month 1 vaccinations/visits ] [ Designated as safety issue: Yes ]
Number of participants reporting systemic adverse experiences [ Time Frame: Day 1 to Day 15 following Day 1/Month 1 vaccinations/visits ] [ Designated as safety issue: Yes ]
The percentage of participants who achieve acceptable levels of anti-diphtheria and anti-tetanus titers [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]
The anti-pertussis (anti-pertussis toxin [anti-PT], anti-filamentous hemagglutinin [anti-FHA] anti-fimbrial agglutinogens [anti-FIM], and anti-pertactin [anti-PRN]) geometric mean titers (GMTs) [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]
The percentages of participants with acceptable levels of titers for polio antigens [ Time Frame: One month after REPEVAX™ vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of participants who seroconvert for each of the human papillomavirus (HPV) types contained in V503 [ Time Frame: 4 weeks post-dose 3 of V503 ] [ Designated as safety issue: No ]

Enrollment:	1054
Study Start Date:	April 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Concomitant	Biological: V503 Vaccine V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 Biological: REPEVAX™ (Concomitant) REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1
Experimental: Non-concomitant	Biological: V503 Vaccine V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 Biological: REPEVAX™ (Non-concomitant) REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

Detailed Description:

This amendment is to update the definitions of adverse event relationship to study vaccine.

Eligibility

Ages Eligible for Study:	11 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01073293 History of Changes
Other Study ID Numbers:	V503-007, 2010_512
Study First Received:	February 19, 2010
Last Updated:	June 22, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on May 23, 2013