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Clinical Trials/CTRI/2013/06/003722
CTRI/2013/06/003722
Completed
Phase 4

Comparative evaluation of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine (bOPV) and trivalent oral poliovirus vaccine (tOPV) in the standard EPI schedule, with or without inactivated polio vaccine (IPV) administration at DTP3 contact: A randomized controlled trial - WHO EPI Study

World health Organization0 sites900 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
World health Organization
Enrollment
900
Status
Completed
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
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Full term ( \>37 weeks) healthy newborn delivered by a normal vaginal delivery or LSCS at the study site hospital
  • •2\.Birth weight of \>2\.5 kg and Apgar score \>9 at 5 min
  • •3\.Residing within a relatively short and easily accessible distance ( \< 30 km)
  • •4\.Judged to be able to attend all scheduled study visits and comply with the study procedures
  • •5\.Parent or Legally Acceptable Representative (LAR) provides written informed consent or oral witnessed consent for the babyâ??s inclusion

Exclusion Criteria

  • •1\.Preterm (gestation age 37 weeks) baby or high risk delivery
  • •2\.Birth weight 2\.5 kg or Apgar score at 5 min 9
  • •3\.Any diagnosed/suspected medical condition or congenital defect which requires active management or hospitalization; as judged by the investigator
  • •4\.Residence 30 km from study site
  • •5\.Baby and the family expected not to be available for the study visits during the study period
  • •6\.Parent/LAR does not consent for their babyâ??s participation
  • •7\.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
  • •8\.Thrombocytopenia or a bleeding disorder

Outcomes

Primary Outcomes

Not specified

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