Comparative evaluation of immunogenicity of variable dose schedules of Inactivated Poliovirus Vaccine in routine immunization: A multi-centric open label randomized controlled trial (India f-IPV study-2025)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- 1. Compare the gains in seroconversion and antibody titres against poliovirus serotype 2 after third fractional or full IPV dose given at 9-12 months age at MR vaccination visit in the routine immunization schedule.
研究概览
简要总结
This is a two arm, multicentric, open label, randomized clinical trial. A total of 3 scheduled physical visits are planned for the study. Visit 1 (Day 0) Screening Visit / baseline blood sample collection /Vaccination. Telephonic Call (Day 3) Study personnel will contact parents/LAR on third day of the vaccine injection to see any local reactions and ask the parents about any ill health. Visit 2 (Day 7) (+4 days window period), Follow-up Visit for blood sample collection. Visit 3 (Day 30 End of study visit) (+7 days window period), Follow-up Visit for blood sample collection. Infants in Arm A will only be given a dose of fractional IPV (0.1 ml, intradermal) while infants in Arm B will be vaccinated with full dose of IPV (0.5 ml, Intramuscular). Both arms will receive the scheduled first MR vaccine along with any other vaccine recommended in the Expanded Programme of Immunization of that state. Baseline 1 ml blood samples will be collected at the first visit. The participants will be followed up next week for another 1 ml blood sample collection (priming effect of IPV). Finally, a second follow up visit will be done one month after the first study visit when another 1 ml blood sample (for seroconversions from additional IPVs given at enrolment) will be collected. No additional follow-up is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 9.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •1.All infants visiting study site immunization clinic for first MR vaccine at 9 to 12 months of age.
- •Infants with documentary evidence having taken 4 bOPV doses and two f-IPV doses per the routine schedule.
- •Judged to be healthy by the investigator for study participation.
- •Parents judged to be able to attend all scheduled study visits and comply with the study procedures.
- •Parent or Legally Acceptable Representative (LAR) provides written informed consent for the baby’s inclusion in the study.
排除标准
- •Not fulfilling any of the inclusion criteria
- •Taken any polio vaccine/s other than the national EPI schedule or Polio Immunization Campaigns.
- •Any diagnosed/suspected medical condition which requires active management or hospitalization as judged by the investigator.
- •A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family).
- •Thrombocytopenia or a bleeding disorder.
结局指标
主要结局
1. Compare the gains in seroconversion and antibody titres against poliovirus serotype 2 after third fractional or full IPV dose given at 9-12 months age at MR vaccination visit in the routine immunization schedule.
时间窗: The primary endpoint is the seroconversion against serotype 2 poliovirus, 1 month (30 days) after IPV vaccination in the study.
次要结局
- 1. Assess persistence of serotype 2 antibodies at enrollment after two primary fIPV doses.(2. Assessment of priming response following two primary fIPV doses.)
研究者
Dr Shailesh D Pawar
Indian Council of Medical Research (ICMR)-National Institute of Virology, Mumbai Unit