NCT00604058已完成2 期
Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination
研究概览
简要总结
The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 42 Days 至 50 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria to be checked at the screening visit (SC):
- •Aged 0 to 7 days on the day of screening
- •Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- •Informed consent form signed by the parent(s) or other legally acceptable representative
- •Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •Inclusion Criteria to be checked at the randomization visit (V01):
- •Aged 42 to 50 days on the day of inclusion
- •Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
排除标准
- •Exclusion Criteria to be checked at the screening visit (SC):
- •Planned participation in another clinical trial during the present trial period
- •Illness that could interfere with trial conduct or completion, in the opinion of the investigator
- •Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- •History of seizures
- •Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- •Thrombocytopenia or bleeding disorder contraindicating IM injection
- •Exclusion Criteria to be checked at the randomization visit (V01):
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- •Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
- •History of seizures
- •Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- •History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
- •Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
结局指标
主要结局
The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination
时间窗: 1 Month Post-vaccination
次要结局
- Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines(1 Month post-vaccination)
研究者
研究点 (1)
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