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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2019

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At a glance

  • Drugs JNJ 64152348 (Primary) ; Diphtheria tetanus and pertussis vaccine; Haemophilus vaccines; Hepatitis B vaccine; Pneumococcal vaccine conjugate; Rotavirus vaccines
  • Indications Poliomyelitis
  • Focus Adverse reactions
  • Sponsors Janssen Vaccines and Prevention B.V
  • Most Recent Events

    • 31 Oct 2019 Status changed from active, no longer recruiting to completed.
    • 09 Sep 2019 Planned End Date changed from 16 Jan 2020 to 30 Sep 2019.
    • 22 Jan 2019 Status changed from recruiting to active, no longer recruiting.
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