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Trial record 5 of 3186 for:    Mexico | Mexico

FASTER-Tlalpan Study (FASTER)

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ClinicalTrials.gov Identifier: NCT03105856
Recruitment Status : Active, not recruiting
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
JORGE SALMERON, Instituto Nacional de Salud Publica, Mexico

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 18,000 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.


Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia HPV-Related Cervical Carcinoma Biological: CERVARIX Biological: GARDASIL Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: HPV Vaccination Impact on Cervical Cancer Screening Program: FASTER-Tlalpan Study in Mexico
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CERVARIX
hrHPV-based screening and HPV16/18 L1 VLP AS04 vaccine (Cervarix®) group according to a two-dose schedule (0-12 months)
Biological: CERVARIX
- 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.

Biological: GARDASIL
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.

Active Comparator: GARDASIL
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: CERVARIX
- 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.

Biological: GARDASIL
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.

No Intervention: CONTROL GROUP
Control group who will receive only hrHPV-based screening.



Primary Outcome Measures :
  1. Inicidence 6-month persistent infection of HPV 16 or HPV 18 in women aged between 25-45 [ Time Frame: During the study (10 years) ]
    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


Secondary Outcome Measures :
  1. Incidence of cervical intraepitelial neoplasia of grade 2 in women aged between 25-45 years [ Time Frame: During the study (10 years) ]
    The incident of cervical intraepitelial neoplasia of grade 2 in women aged between 25-45 years, confirmed histologically by a biopsy after a positive hrHPV-based screening after completion an avarage of 10 years of study



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03105856


Locations
Mexico
Jorge Salmeron
Mexico Distrito Federal, Ciudad de Mexico, Mexico
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Investigators
Principal Investigator: JORGE SALMERON, PhD Instituto Nacional de Salud Publica, Mexico

Additional Information:
Responsible Party: JORGE SALMERON, Principal Researcher, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT03105856     History of Changes
Other Study ID Numbers: 1417
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by JORGE SALMERON, Instituto Nacional de Salud Publica, Mexico:
Mass screening
Vaccination
Mexico

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs