Clinical trial NCT01304498: Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)
Official title: A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Papillomavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 600
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective:

• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

Secondary objectives:

* To evaluate the tolerability of V503 in 9-15 year-old girls.
* To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.


Eligibility criteria: Inclusion Criteria:

* Female from 9 to 15 years old.
* Good physical health.

Exclusion Criteria:

* Known allergy to any vaccine component.
* History of severe allergic reaction.
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Pregnant subject.
* Immunocompromised or immunodeficient subject.
* Splenectomy.
* Receipt of medication / vaccine that may interfere with study assessment.
* Fever
* History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
* Any condition that might interfere with study assessment.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) to HPV Types 16 and 18
timeFrame: 4 weeks postdose 3 (Month 7)
Secondary outcomes:
measure: GMTs to HPV Types 6 and 11
timeFrame: 4 weeks postdose 3 (Month 7)
measure: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18
timeFrame: 4 weeks postdose 3 (Month 7)
measure: Percentage of Participants With One or More Adverse Events
timeFrame: Up to Month 7
measure: Percentage of Participants With One or More Injection-site Adverse Reactions
timeFrame: Up to 5 days after any vaccination
measure: Percentage of Participants With One or More Systemic Adverse Events
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants With Maximum Oral Temperature ≥37.8°C
timeFrame: Up to 15 days after any vaccination
measure: Percentage of Participants With One or More Serious Adverse Events
timeFrame: Up to Month 7
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Brodszki N, van Damme P, Diez-Domingo J, Icardi G, Petersen LK, Tran C, Thomas S, Luxembourg A, Baudin M. A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil(R) in 9-15-Year-Old Girls. Pediatr Infect Dis J. 2015 Sep;34(9):992-8. doi: 10.1097/INF.0000000000000773.
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.