NCT03105856

Brief Summary

Objective. To evaluate the impact of HPV vaccination as part of a hrHPV-based primary screening program to extend screening intervals. Materials and methods. A total of 3,000 women aged 25-45 years, attending the regular cervical cancer-screening program in primary health care services in Tlalpan, Mexico City, will be invited to the study. Eligible participants will be assigned to one of three comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening. Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will be conducted to estimate safety profiles at different screening intervals; participants will undergo diagnosis confirmation and treatment as necessary. Discussion: The FASTER-Tlalpan Study will provide insights into new approaches of cervical cancer prevention programs. It will offer valuable information on potential benefits of combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

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

January 3, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

January 24, 2017

Last Update Submit

August 6, 2020

Conditions

Cervical Intraepithelial NeoplasiaHPV-Related Cervical Carcinoma

Keywords

Mass screeningVaccinationMexico

Outcome Measures

Primary Outcomes (1)

  • Inicidence 6-month persistent infection of HPV 16 or HPV 18 in women aged between 25-45

    The inicident 6-month persistent infection of HPV 16 or HPV 18 in women aged between 25-45 years, determining the positivity hrHPV with molecular techniques in orine samples after 30 and 36 months after a hrHPV-based screening after completion an average of 10 years of study

    During the study (10 years)

Secondary Outcomes (1)

  • Incidence of cervical intraepitelial neoplasia of grade 2 in women aged between 25-45 years

    During the study (10 years)

Study Arms (3)

CERVARIX

ACTIVE COMPARATOR

hrHPV-based screening and HPV16/18 L1 VLP AS04 vaccine (Cervarix®) group according to a two-dose schedule (0-12 months)

Biological: CERVARIXBiological: GARDASIL

GARDASIL

ACTIVE COMPARATOR

hrHPV-based screening and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) (Gardasil®) vaccine group according to a two-dose schedule (0-12 months)

Biological: CERVARIXBiological: GARDASIL

CONTROL GROUP

NO INTERVENTION

Control group who will receive only hrHPV-based screening.

Interventions

CERVARIXBIOLOGICAL

\- HPV16/18 L1 VLP AS04 vaccine (Cervarix®) group according to a two-dose schedule (0-12 month). This group will receive the HPV16/18 vaccine containing HPV16 and HPV18 L1 virus-like-particles (20 μg of each) adjuvanted with 50 μg 3-O-desacyl-4'-monophosphoryl lipid A and 0.5 mg aluminum hydroxide (GlaxoSmithKline Biologicals, Rixensart, Belgium). A 0.5-mL dose of the vaccine will be administered in the non-dominant arm.

CERVARIXGARDASIL
GARDASILBIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) (Gardasil®) recombinant vaccine according to a two dose schedule (0-12 month). This group will receive amorphous aluminum hydroxyphosphate sulfate adjuvanted quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine (Merck Sharp \& Dohme Corp. Whitehouse Station, NJ, USA). A 0.5-mL dose of the vaccine will be administered in the non-dominant arm.

CERVARIXGARDASIL

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female aged 25 to 45 years at the time of the first vaccine dose.
  • Willing to comply with the requirements of the protocol (e.g., return for follow-up visits).
  • Written informed consent prior to enrollment.

You may not qualify if:

  • Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
  • Planning to become pregnant or planning to discontinue contraceptive precautions during the first twelve months of the study (months 0-12).
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.
  • Any other medical condition or disease that could compromise the life of the participant during enrollment in the study.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first dose of the study vaccine.
  • Previous vaccination against human papillomavirus.
  • History of cervical cancer or hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jorge Salmeron

Mexico City, Mexico City, Mexico

Location

Related Publications (1)

  • 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

Related Links

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

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

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • JORGE SALMERON, PhD

    Instituto Nacional de Salud Publica, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Researcher

Study Record Dates

First Submitted

January 24, 2017

First Posted

April 10, 2017

Study Start

January 3, 2017

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

ME(1)