A phase III clinical trial to study the safety and immunogenicity of BEs combined pentavalent DTwP-rHepB-HIB liquid vaccine administered to 6-8 week old healthy Infants of either gender in comparison with a marketed vaccine.

Phase 3

Completed

• Conditions: Health Condition 1: Z23- Encounter for immunization

• Registration Number: CTRI/2009/091/000456
• Lead Sponsor: Biological E Limited Azamabad Hyderabad AP India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-10-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1.Intended subjects will be healthy infants between 6 to8 weeks of age that is 42 to 56 days of age,both days inclusive of either gender at the time of 1st vaccination.

2.Written informed consent obtained from the subjectâ??s parents or legal representative or guardian.

3.Healthy infants with weight greater than or equal to 3300 gms at the time of screening.

4.Good clinical condition established by medical history and physical examination with no acute disease, infection or high temperature that is greater then 38.5 degrees C axillary temperature.

5.Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.

6.Subjects or their mothers not participating in any other trials.

7.Infants without contraindications or precautionary circumstances for participating in the trial

8.Ability of the subjectâ??s parent or legal representative or guardian to understand and comply with the requirements of the protocol.

Exclusion Criteria

Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral polio vaccine; Current illness (especially fever) or any acute or congenital illness or disability; Known or suspected allergy to any of the vaccine components; Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS); Known family history of SIDS (Sudden Infant Death Syndrome); Inability or unwillingness to abide by the requirements of the protocol; Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified