A clinical trial to assess and compare the safety of Pentavac Vaccine (DTP-HB+Hib) of SIIL with Tritanrix-HB-HIB of GSK in Indian infants.

Phase 4

Completed

• Registration Number: CTRI/2009/091/000615
• Lead Sponsor: Serum Institute of India Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

1)Normal healthy infants of age 6-8 weeks at the time of the first vaccination2)Parents/Legal Guardian of subject willing to give written informed consent 3)Parents/Legal Guardian willing to comply with study protocol.4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination.5)The participant should be the resident of study area.

Exclusion Criteria

1)Infant subject participating in other clinical trial or planned participation in another clinical trial 2) Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component 4)Infant with chronic illness. 5)Infant who receive blood or blood?derived products in the past. 6)Known history of a bleeding disorder. 7)History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of solicited adverse reaction within 3 days of each vaccine dose.Timepoint: within 3 days of each vaccine dose.

Secondary Outcome Measures

Name	Time	Method
1)Occurrence of unsolicited adverse eventsTimepoint: within 28 days following the administration of each vaccine dose.