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

March 6, 2015 updated by: Malaquías López Cervantes, Universidad Nacional Autonoma de Mexico

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.).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico city
      • Mexico, Mexico city, Mexico, 04510
        • Recruiting
        • Malaquias Lopez Cervantes
        • Contact:
        • Contact:
          • Reyna Lizette Pacheco, Dr. Sc.
          • Phone Number: +525556232373
          • Email: lirey@unam.mx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine
dose scheme (0 and 6 month)
Other Names:
  • Gardasil
Active Comparator: 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.
Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine
dose scheme (0 and 6 month)
Other Names:
  • Gardasil
Active Comparator: 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.
Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine
dose scheme (0 and 6 month)
Other Names:
  • Gardasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 months (1 month after the last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Collaborators

Merck Sharp & Dohme LLC
Secretaria de Salud, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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