NCT02382900

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

March 3, 2015

Last Update Submit

March 6, 2015

Conditions

Human Papilloma Virus

Keywords

quadrivalentvaccine

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Cohort 2

ACTIVE COMPARATOR

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

Cohort 3

ACTIVE COMPARATOR

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

Interventions

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

dose scheme (0 and 6 month)

Also known as: Gardasil
Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age10 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All those children whose parents accept their participation in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaquias Lopez Cervantes

Mexico City, Mexico City, 04510, Mexico

RECRUITING

MeSH Terms

Interventions

Vaccines, SyntheticHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Recombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccinesBiological ProductsComplex MixturesAntigensBiological FactorsVaccines, CombinedPapillomavirus VaccinesViral Vaccines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph D

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

ME(1)