A Clinical study of Pentavalent vaccine

Phase 4

Completed

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

• Registration Number: CTRI/2009/091/000665
• Lead Sponsor: Serum Institute Of India Ltd Pune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

ï?·Children who received DTwP-HB-Hib vaccine (adsorbed) manufactured by Serum Institute of India Ltd. or Panacea Biotec Ltd. during primary vaccination series during Phase III clinical trial (Protocol ID:DTPw-HB-Hib/SIIL/07/2007).

ï?·Age 15 ? 24 months.

ï?·Parents willing for participation of their child in the study and sign written informed consent.

Exclusion Criteria

History of receipt of booster dose of any of the components of vaccine.

History of significant and/or persistent neurological/ developmental disorder or hematological, hepatic, renal, cardiac, respiratory disease.

 Child under immunosuppressive therapy

 History of allergic reaction to any vaccine.

 Receipt of any other vaccine during the study period with exception of

Oral Polio Vaccine (OPV) & Measles Mumps and Rubella (MMR) vaccine.

Administration of immunoglobulins or any blood products since birth.

Axillary temperature  38C.

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

Major congenital or hereditary immunodeficiency.

Simultaneous participation in any other clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified