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Clinical trial

A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines

NCT03566940 is registered in ClinicalTrials.gov with Janssen Vaccines & Prevention B.V. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines
Lead sponsor
Janssen Vaccines & Prevention B.V.
Phase
Phase 2
Overall status
Completed
Start date
July 31, 2018
Completion date
October 17, 2019
Enrollment
302 (actual)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

healthy