Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN80143849
ISRCTN80143849
Completed
Not Applicable

Comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in India (Panacea Biotec Ltd mOPV1 study)

Panacea Biotec Ltd (India)0 sites600 target enrollmentFebruary 1, 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPolioInfections and Infestations

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polio
Sponsor
Panacea Biotec Ltd (India)
Enrollment
600
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 1, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Panacea Biotec Ltd (India)

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy newborns (greater than or equal to 2\.75 kg birth weight, apgar score at 5 minutes, greater than or equal to 9\) at the study site(s) (large maternity hospitals)
  • •2\. Residing within a relatively short and easily accessible distance (less than 30 km)
  • •3\. Not planning to travel away during entire the study period (birth \- 2 months)

Exclusion Criteria

  • •1\. Newborns requiring hospitalisation
  • •2\. Birth weight below 2\.75 kg
  • •3\. Apgar score at 5 minutes less than 9
  • •4\. Residence greater than 30 km from study site
  • •5\. Families expecting to be absent during the 60\-day study period
  • •6\. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
Comparative evaluation of immunogenicity of monovalent type 1 oral poliovirus vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in EgyptPolioInfections and Infestations
ISRCTN76316509World Health Organization (WHO) (Switzerland)600
Completed
Not Applicable
Comparative evaluation of Immunogenicity of monovalent type 1 Oral Poliovirus Vaccine (mOPV1) and monovalent type 3 Oral Poliovirus Vaccine (mOPV3) versus trivalent Oral Poliovirus Vaccine (tOPV): a randomised double-blind controlled trial in South AfricaPoliomyelitisInfections and Infestations
ISRCTN18107202World Health Organization (WHO) (Switzerland)800
Withdrawn
Phase 4
A comparison of the immune response to two different oral polio vaccine regimes in PakistaPoliomyelitisPublic Health - EpidemiologyInfection - Other infectious diseasesOral and Gastrointestinal - Normal oral and gastrointestinal development and function
ACTRN12611000824965Department of Paediatrics and Child Health, Aga Khan University800
Not yet recruiting
Phase 4
Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunizatio
CTRI/2017/02/007793Panacea Biotec Ltd800
Not yet recruiting
Phase 1
imotuzumab in COVID-19COVID-19SARS-CoV2Coronavirus InfectionsSARS VirusCoronaviridae InfectionsBetacoronavirusAcute DiseaseCritical Care
RPCEC00000369Center of Molecular Immunology (CIM)40