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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02382900
Other study ID # 091-2014
Secondary ID
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


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
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