Clinical trial NCT01073293: A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 1054
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503
timeFrame: 4 weeks following Month 6 vaccination
measure: Percentage of Participants With a V503 Injection-site Adverse Experience
timeFrame: Day 1 through Day 5 following Day 1 vaccination
measure: Percentage of Participants With a Repevax™ Injection-site Adverse Experience
timeFrame: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
measure: Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)
timeFrame: Up to 5 days following the Day 1 and Month 1 vaccination / visit
measure: Percentage of Participants With a Systemic Adverse Experience
timeFrame: Up to 15 days following the Day 1 and Month 1 vaccination / visit
measure: Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
timeFrame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
measure: Geometric Mean Titers of Pertussis Antibody Responses
timeFrame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
measure: Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody
timeFrame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
Secondary outcomes:
measure: Percentage of Participants Who Seroconvert for Each of the HPV Types
timeFrame: Month 7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kosalaraksa P, Mehlsen J, Vesikari T, Forsten A, Helm K, Van Damme P, Joura EA, Ciprero K, Maansson R, Luxembourg A, Sobanjo-ter Meulen A. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Pediatr Infect Dis J. 2015 Jun;34(6):627-34. doi: 10.1097/INF.0000000000000694.
citation: Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.