Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunization in the post tOPV-bOPV period: A multi-centric open label randomized controlled trialâ€(India fractional dose IPV study)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- 1.The primary endpoint is the seroconversion against type 2 poliovirus, four weeks after completion of doses given in the routine immunization schedule in all the study arms.
研究概览
简要总结
Allbabies who visit study institution for routine vaccination at 6 weeks of ageand immunized with birth dose of bOPV will be considered for theenrolment. If a baby fulfils the eligibility criteria, a complete informedconsent process will be followed as per the applicable regulatory requirements.As IPV for the study is already licenced and being given to millions of infantsin India as per the present routine immunization schedule, it is not proposedto audio-video record the informed consent process
Babies fulfilling eligibility criteria and whose parents have providedinformed consent will be randomized into one of the four study arms (A, B1, B2& C). On enrolment at week six, one millilitre (ml) of blood sample will becollected from each study participant by venepuncture followed byadministration of vaccine/s as per the allocated study arm. Parents will beadvised to avoid any other vaccine from centres other than the study site. Forevery study infant, a study specific immunization card will be issued indicatingthe baby to be a study subject and that all routine vaccinations will beadvised and taken care of by the study site investigator during this period. Parentswill be informed about the date of next follow visit during the previous visit.Reminder telephonecontacts/household visits will be arranged through studystaff.
At 10 and 14 week visits, the study vaccine/s will be administered asper the allocated study arm. At 14 week visit one ml blood will be collectedfrom each study participant by venepuncture followed by administration ofvaccine/s as per the study arm. At 18 weeks, one ml blood will be collected byvenepuncture in all the study arms.
In study arm A, IPV full dose will be given intramuscularly in theanterolateral side of the right thigh using AD syringe. In arm B1 and C,fractional dose IPV will be administered intradermally in right upper arm usingBCG needle syringe. In Arm B2, fractional dose IPV will be administeredintradermally in right upper arm using West/Helm adapter intradermal device.
The study subjects will continue getting other EPI vaccinesconcurrently, except polio vaccines which they shall receive as per the studyarm. After having fulfilled the study requirements at 18 weeks, infants willexit the study. The infants will be referred to the routine vaccination programfor the subsequent vaccination according to the national immunization schedule.
All trial related interventions will be conducted bystudy personnel; the only subject compliance required is to abide by scheduledvisits and fill subject diary cards.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 42.00 Day(s) 至 48.00 Day(s)（—）
- 性别
- All
入选标准
- •1.All infants visiting study site immunization clinic for OPV1/Penta1 immunization 2.The infant should be 6-7 completed weeks of age at OPV1/Penta1 contact 3.Infants with documentary evidence having taken birth dose of bOPV 4.Weight at enrolment visit of ≥ 3.2 Kgs 5.Judged to be healthy by the investigator for study participation 6.Parents judged to be able to attend all scheduled study visits and comply with the study procedures 7.Parent or Legally Acceptable Representative (LAR) provides written informed consent for the baby’s inclusion in the study.
排除标准
- •1.Not fulfilling any of the inclusion criteria 2.Taken any polio vaccine/s other than birth dose of bOPV 3.Any diagnosed/suspected medical condition which requires active management or hospitalization; as judged by the investigator 4.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) 5.Thrombocytopenia or a bleeding disorder.
结局指标
主要结局
1.The primary endpoint is the seroconversion against type 2 poliovirus, four weeks after completion of doses given in the routine immunization schedule in all the study arms.
时间窗: 6, 10 and 14 week
次要结局
- 4.Number of adverse events (AEs) occurred during the study(through out the study)