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

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.).

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02382900

Enrollment

500

Registered

2015-03-09

Start date

2015-02-28

Completion date

2015-12-31

Last updated

2015-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus

Keywords

quadrivalent, vaccine

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.

Interventions

BIOLOGICALquadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine

dose scheme (0 and 6 month)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 11 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026