A Post licensure clinical study to compare and evaluate safety, reactogenicity and Lot-to-Lot consistency of three production batches of liquid pentavalent DTwP-rHepB-HIB vaccine manufactured by BE LTD in healthy 6 to 8 week old infants.

Phase 4

Completed

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

• Registration Number: CTRI/2011/04/001675
• Lead Sponsor: Biological E Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-09-14
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 660

Inclusion Criteria

Intended subjects will be healthy infants between 6-8 weeks of age, of either gender at the time of 1st vaccination.

Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian.

Healthy infants with weight equal to or more than 3300 gms at the time of 1st vaccination.

Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature).

Healthy infants born to mothers sero-negative to HIV, HBV and HCV as confirmed by blood tests on the mother or based on maternity discharge summary.

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

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

Ability of the subjects parent or legally acceptable representative/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/injectable polio vaccine.

Current illness (especially fever) or any acute or congenital illness or disability.

Subjects receiving immunosuppressive therapy.

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).

Planned or elective surgery during the course of the study.

Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.

Subjects and their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.

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