FUTURE IIA Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
+ Matching Placebo
Neoplasias del Cuello Uterino+22
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Prevención
Resumen
Fecha de inicio: 14 de junio de 2002
Fecha en la que se inscribió al primer participante.In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASIL™ or matching placebo at Day 1, Month 2, and Month 6 and were assessed for efficacy, immunogenicity, and safety. In the Base Study Extension (EXT) \[V501-015-10\], participants who received placebo or only 1 dose of GARDASIL™ in the Base Study, were given 3 doses of open-label GARDASIL™ at EXT Day 1, EXT Month 2, and EXT Month 6, and were followed to EXT Month 7. Participants who who received 2 doses of GARDASIL™ in the Base Study were given 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days). In the 10-year Base Study Long-Term Follow-Up (LTFU) \[V501-015-21\] the effectiveness, immunogenicity and safety of GARDASIL™ was assessed during a period of 10 years following completion of the Base Study (V501-015) \[14 years after the first dose of GARDASIL™\] and, for some measures, the Base Study EXT (V501-015-10) \[10 years after the first dose of GARDASIL™\]. Participants from Denmark, Iceland, Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU. Effectiveness and safety was assessed by registry-based follow-up, and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU. An 8-year extension was added to the LTFU (V501-015-22\] to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASIL™. Effectiveness and safety will be assessed by registry-based follow-up, and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 12.167 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 16 a 23 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria for the Base Study: * Healthy women with an intact uterus with lifetime history of 0-4 sexual partners --For Extension Phase: * Participant received placebo or an incomplete vaccination series in the original study --For LTFU: * Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden. * Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection Exclusion Criteria for the Base Study: * Prior Human Papilloma Virus (HPV) vaccination * Prior abnormal Paps * Prior history of genital warts --For Extension Phase: * Prior complete HPV vaccination series * Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil --For LTFU Study: * There were no exclusion criteria that did not overlap the inclusion criteria for this study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios