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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Papilloma Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1

11 year old boys enrolled in fifth grade of 40 public elementary schools of Mexico City, from the political demarcations of Azcapotzalco, Gustavo A. Madero, Iztacalco, Miguel Hidalgo, Venustiano Carranza, Iztacalco and Tlalpan, reciving a two-dose vaccination scheme (0-6). 250 subjects will be recruited.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

dose scheme (0 and 6 month)

Cohort 2

Historical cohort of young women 18-24 years old recruited by Lazcano et. al. receiving a standard vaccination schedule (0-1-6 months). 500 subjects were recruited.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

dose scheme (0 and 6 month)

Cohort 3

11 year old girls enrolled in fifth grade of 40 public elementary schools of Mexico City, from the political demarcations of Azcapotzalco, Venustiano Carranza, Iztacalco and Tlalpan, reciving a two-dose vaccination scheme (0-6). 250 subjects will be recruited.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

dose scheme (0 and 6 month)

Interventions

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

dose scheme (0 and 6 month)

Intervention Type BIOLOGICAL

Other Intervention Names

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Gardasil

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes