Phase III, randomized, blind-observer, multi-center, four-arm, parallel-group trial in 2133 infants

Sanofi Pasteur SA0 个研究点目标入组 2,133 人开始时间: 2012年4月10日最近更新: 2012年4月18日

试验速览

暂无简介。

•1) Two-month-old infants (50 to 71 days old inclusive) on the day of inclusion
•2) Born at full term of pregnancy (=37 weeks) with a birth weight =2.5 kg
•3) Informed Consent Form signed by one or both parents, or by a legally acceptable representative, and one or two independent witnesses. (In Peru, parents/legally acceptable representatives' finger print and an independent witness' signature were required if the parents/legally acceptable representative was illiterate)
•4) Able to attend all scheduled visits and to comply with all trial procedures
•5) Had complied with the national immunization calendar (Bacille Calmette-Guérin [BCG] for both countries) for the first 2 months of life (e.g. Mexico: no dose of Hep B vaccine since birth; Peru: one dose of Hep B vaccine at birth)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2133
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
•2) Planned participation in another clinical trial during the present trial period
•3) Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroids therapy
•4) Subjects with congenital or acquired immunodeficiency in the child's surroundings
•5) Systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
•6) Chronic illness at a stage that could have interfered with trial conduct or completion
•7) Blood or blood-derived products received since birth
•8) Any vaccination in the 4 weeks preceding the first trial vaccination
•9) Vaccination planned in the 4 weeks following the trial vaccination
•10) Documented history of pertussis, T, D, poliomyelitis (polio), Hib, or Hep B infection(s) (confirmed either clinically, serologically, or microbiologically)
•11) Mother known as seropositive for human immunodeficiency virus or hepatitis C, or known carrier of HBs Ag
•12) Previous vaccination against pertussis, T, D, polio, or Hib infection(s)
•13) Coagulopathy, thrombocytopenia, or a bleeding disorder contraindicating IM vaccination
•14) History of seizures
•15) Febrile (rectal equivalent temperature =38.0°C) or acute illness on the day of inclusion

发起方

Sanofi Pasteur SA