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Clinical Trials/CTRI/2017/02/007793
CTRI/2017/02/007793
Not yet recruiting
Phase 4

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) - WHO fIPV study

Panacea Biotec Ltd0 sites800 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Panacea Biotec Ltd
Enrollment
800
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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 babyâ??s inclusion in the study

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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