Clinical trial NCT00988884: A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
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 Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Papillomavirus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 1241
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 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™.


Eligibility criteria: 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

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 >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups
timeFrame: Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
measure: Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
timeFrame: 4 weeks following Day 1 or Month 1 vaccination
measure: Geometric Mean Titers of Pertussis Antibody Responses
timeFrame: 4 weeks following Day 1 or Month 1 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 Menactra™ or Adacel™ Injection-site Adverse Experience
timeFrame: Day 1 through Day 5 following Day 1 or Month 1 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
Secondary outcomes:
measure: Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503
timeFrame: Month 7
measure: Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™
timeFrame: 4 weeks following Day 1 or Month 1 vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Rodrigues S, Grenha A. Activation of Macrophages: Establishing a Role for Polysaccharides in Drug Delivery Strategies Envisaging Antibacterial Therapy. Curr Pharm Des. 2015;21(33):4869-87. doi: 10.2174/1381612821666150820103910.
citation: Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, Engel E, Huicho L, Shew M, Maansson R, Caldwell N, Luxembourg A, Ter Meulen AS. Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines. Pediatrics. 2015 Sep;136(3):e563-72. doi: 10.1542/peds.2014-4199. Epub 2015 Aug 3.
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.