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
Price :
$35
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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
- 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))