FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program

PHASE4CompletedINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

January 3, 2017

Primary Completion Date

December 15, 2018

Study Completion Date

December 15, 2018

Conditions
Cervical Intraepithelial NeoplasiaHPV-Related Cervical Carcinoma
Interventions
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.

Trial Locations (1)

Unknown

Jorge Salmeron, Mexico City

All Listed Sponsors
lead

Instituto Nacional de Salud Publica, Mexico

OTHER

NCT03105856 - FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program | Biotech Hunter | Biotech Hunter