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Trial record 2 of 3186 for:    Mexico | Mexico

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

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ClinicalTrials.gov Identifier: NCT02382900
Recruitment Status : Unknown
Verified March 2015 by Malaquías López Cervantes, Universidad Nacional Autonoma de Mexico.
Recruitment status was:  Recruiting
First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Secretaria de Salud, Mexico
Information provided by (Responsible Party):
Malaquías López Cervantes, Universidad Nacional Autonoma de Mexico

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.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.).
Study Start Date : February 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Gardasil




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   10 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382900


Locations
Mexico
Malaquias Lopez Cervantes Recruiting
Mexico, Mexico city, Mexico, 04510
Contact: Malaquias Lopez, Ph. D.    +525556232427    mlopez14@unam.mx   
Contact: Reyna Lizette Pacheco, Dr. Sc.    +525556232373    lirey@unam.mx   
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
Merck Sharp & Dohme Corp.
Secretaria de Salud, Mexico

Responsible Party: Malaquías López Cervantes, Ph D, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT02382900     History of Changes
Other Study ID Numbers: 091-2014
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by Malaquías López Cervantes, Universidad Nacional Autonoma de Mexico:
quadrivalent
vaccine

Additional relevant MeSH terms:
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs