An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySix (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.

Trial Profile

An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySix (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.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Mar 2018

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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