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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official 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

Brief Summary: In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most common oncogenic "high-risk" genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are HPV associated. A large number of studies, including both adult and young females, have demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection against infection. Immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. Recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.

Detailed Summary:
Sponsor: Universidad Nacional Autonoma de Mexico

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

Geometric means will be compared between the two groups of interest (boys and young women)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidad Nacional Autonoma de Mexico

Dates:
Date Received: March 3, 2015
Date Started: February 2015
Date Completion: December 2015
Last Updated: March 6, 2015
Last Verified: March 2015