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An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySixTM (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.) with Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants. - EasySix study

Trial Profile

An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySixTM (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.) with Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants. - EasySix study

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Hib-DTP-hepatitis B-poliovirus vaccine (Primary) ; Hib-DTP-hepatitis B vaccine; Poliovirus vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics
  • Sponsors Panacea Biotec
  • Most Recent Events

    • 23 Mar 2018 Primary endpoint (Seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-HepB-Hib-IPV vaccine in the two treatment groups) has been met, according to results published in the Vaccine Journal.
    • 23 Mar 2018 Primary endpoint (Seroresponsiveness against pertussis (Anti PT and Pertussis IgG)) has been met, according to results published in the Vaccine Journal.
    • 23 Mar 2018 Primary endpoint has been met. (Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B, Hib (PRP): Seroprotection rate (SPR; difference in the SPRs between treatment groups))
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