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.
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
- 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))