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

Human Papilloma Virus Clinical Trial

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 and Co.).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02382900
• Other study ID #: 091-2014
• Status: Recruiting
• Phase: Phase 3
• First received: March 3, 2015
• Last updated: March 6, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Universidad Nacional Autonoma de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma

Intervention

Biological:
• quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine
dose scheme (0 and 6 month)

Locations

Country	Name	City	State
Mexico	Malaquias Lopez Cervantes	Mexico	Mexico city

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Mexico	Merck Sharp & Dohme Corp., Secretaria de Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity (Geometric mean antibody concentration will be compared between the two groups)	Geometric means will be compared between the two groups of interest (boys and young women)	7 months (1 month after the last dose)	Yes