NCT01717118

Brief Summary

In September 2009 the National Vaccination Council approved the policy for anti-HPV vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the following justification:

  • Antibody induction due to the vaccine is greater than that produced by natural exposure to the virus
  • Immune response in girls 9 to 11 years of age is similar to the response obtained after three doses in women 16 to 26 years of age
  • The third dose will be administered at the time when maximum protection is required, near the onset of sexual activity Thus the National Institute of Public Health was commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and stratified by vaccine type. The hypothesis is that in 9-year-old girls who are administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels that are not lower than those of adult women who have been administered the traditional scheme (0-1/2-6). The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
  • Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
  • Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
  • Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
  • Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
  • Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
  • Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
  • Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
  • Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
  • Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
  • To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

5.3 years

First QC Date

October 26, 2012

Last Update Submit

August 23, 2018

Conditions

Healthy

Keywords

EvaluationImmunogenicityLevelsWomenHPVVaccineMexico

Outcome Measures

Primary Outcomes (1)

  • To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme

    Bivalent Vaccine: Five hundred females from this age group will be administered the vaccine according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age group will be administered the traditional scheme of 0, 1, 6 months. Tetravalent Vaccine: 150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and 6 months.

    6 months

Secondary Outcomes (1)

  • To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme

    60 months

Study Arms (2)

Tetravalent Vaccine

ACTIVE COMPARATOR

* Month 2 visit: May be scheduled on the appropriate month +/- 3 weeks. * Month 6, 21, 60 and 61 visit (vaccination scheme 0, 2, 6): May be programmed on the appropriate month +/- 4 weeks. * Month 7 and 61 visit (vaccination scheme 0, 6, 60): The time interval between the month 6/60 visit and the month 7/61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination

Biological: Tetravalent Vaccine

Bivalent Vaccine

ACTIVE COMPARATOR

* Month 1 visit: May be scheduled 21 to 62 days after the Day 0 visit. * Month 6 visit: May be scheduled 161 to 216 days after the Day 0 visit. * Month 6 visit: The time interval between the month 6 visit and the month 7 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination. * Month 21, 60 and 61 visit (vaccination scheme 0, 1, 6): May be scheduled on the appropriate month +/- 4 weeks. * Month 61 (vaccination scheme 0, 6, 60) The time interval between the month 60 visit and the month 61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination

Biological: Bivalent Vaccines

Interventions

Bivalent VaccinesBIOLOGICAL
Also known as: CERVARIX
Bivalent Vaccine
Tetravalent VaccineBIOLOGICAL
Also known as: Gardasil
Tetravalent Vaccine

Eligibility Criteria

Age9 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women 18 to 24 years of age who agree to participate by signing an informed consent form prior to recruitment.
  • Girls 9 and 10 years of age whose father/mother/guardian signs the informed consent form to participate in the study.

You may not qualify if:

  • Prior administration of an anti-HPV vaccine
  • Pregnant women or women planning to get pregnant in the next 8 months.
  • Auto-immune diseases
  • Women with a history of Guillain Barré syndrome.
  • Prior administration of immunoglobulins and/or any blood product in the past 6 months before the study's first vaccine dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Médico Cuauhtemoc

Cuernavaca, Morelos, 1299, Mexico

Location

Related Publications (3)

  • Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

    PMID: 41276263DERIVED

  • Lazcano-Ponce E, Torres-Ibarra L, Cruz-Valdez A, Salmeron J, Barrientos-Gutierrez T, Prado-Galbarro J, Stanley M, Munoz N, Herrero R, Hernandez-Avila M. Persistence of Immunity When Using Different Human Papillomavirus Vaccination Schedules and Booster-Dose Effects 5 Years After Primary Vaccination. J Infect Dis. 2019 Jan 1;219(1):41-49. doi: 10.1093/infdis/jiy465.

    PMID: 30085139DERIVED

  • Lazcano-Ponce E, Stanley M, Munoz N, Torres L, Cruz-Valdez A, Salmeron J, Rojas R, Herrero R, Hernandez-Avila M. Overcoming barriers to HPV vaccination: non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months. Vaccine. 2014 Feb 3;32(6):725-32. doi: 10.1016/j.vaccine.2013.11.059. Epub 2013 Dec 16.

    PMID: 24355090DERIVED

MeSH Terms

Interventions

Vaccines, Combinedhuman papillomavirus vaccine, L1 type 16, 18Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

VaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • Eduardo C Lazcano, Phd, MD

    National Institute of Public Health Mexico

    PRINCIPAL INVESTIGATOR

  • Aurelio Cruz, Valdez

    National Institute of Public Health Mexico

    STUDY DIRECTOR

  • Janet L. Pacheco

    National Institute of public Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director of the Center of Research in population health

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

November 1, 2009

Primary Completion

February 1, 2015

Study Completion

August 1, 2018

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

ME(1)