At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants From India Who Previously Received a Dose of Hepatitis B Vaccine at Birth
In Brief
A Phase 3 clinical trial evaluating Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine for Diphtheria and 5 related conditions. Completed, enrolled 177 participants across 2 sites.
Detailed Summary
The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT\~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India. Primary Objective: * To evaluate the immunogenicity of the study vaccine in terms of seroprotection \[diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)\] and vaccine response for pertussis antigens \[pertussis toxoid (PT) and filamentous haemagglutinin (FHA)\] one month after the third dose. Secondary Objectives: * To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose. * To describe the safety after each and any doses of the study vaccine.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular