Two-dose Schedule of Quadrivalent HPV Recombinant Vaccine in 11-year-old Boys in Mexico City

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2015
• Main ID: NCT02382900
• Date of registration: 03/03/2015
• Prospective Registration: No
• Primary sponsor: Universidad Nacional Autonoma de Mexico
• Public title: Two-dose Schedule of Quadrivalent HPV Recombinant Vaccine in 11-year-old Boys in Mexico City
• Scientific title: Evaluation of a Two-dose Schedule of Quadrivalent Human Papilloma Virus (Types 6, 11, 16, 18) Recombinant Vaccine in 11-year-old Boys in Mexico City (Gardasil® Merck and Co.).
• Date of first enrolment: February 2015
• Target sample size: 500
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02382900
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Mexico

Contacts

• Name: Malaquias Lopez, Ph. D.

Key inclusion & exclusion criteria

Inclusion Criteria:

- All those children whose parents accept their participation in the study.

Exclusion Criteria:

- Fever,

- previous vaccination against HPV,

- allergy to vaccine components,

- thrombocytopenia,

- immunosuppression,

- diarrhea,

- vomiting,

- dyscrasia,

- administration of another anti-viral vaccine in the previous 15 days.



Age minimum: 10 Years
Age maximum: 11 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Human Papilloma Virus

Intervention(s)

Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine

Primary Outcome(s)

Immunogenicity (Geometric mean antibody concentration will be compared between the two groups) [Time Frame: 7 months (1 month after the last dose)]

Secondary ID(s)

091-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Secretaria de Salud, Mexico

Merck Sharp & Dohme Corp.