Clinical study to compare immune response and safety of DPT vaccine of Cadila Healthcare Ltd. with DPT vaccine of Serum Institute of India Ltd. in healthy childre

Phase 2

Completed

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

• Registration Number: CTRI/2015/05/005768
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-02-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 288

Inclusion Criteria

1. Healthy infant of either gender between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) at the time of enrollment

2. Subject born after a normal gestational period of 37-42 weeks with birth weight >= 2.5 Kg

3. Body weight >= 3.3 Kg at the time of enrollment

4. Subject in a good clinical condition as judged by the investigator based on medical history and physical examination

5. Written informed consent obtained from the subjectâ??s parents or legally acceptable representative

6. Subjectâ??s parents or legally acceptable representative literate enough to fill the diary card

Exclusion Criteria

1. Any vaccination before enrollment except vaccination with BCG vaccine, Hepatitis-B vaccine and oral polio vaccine

2. Past history of diphtheria, pertussis or tetanus

3. History of known or suspected allergy to any of the vaccine components

4. History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy

5. Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy

6. Subject with history of clinically significant systemic disorder especially neurological disorder

7. Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity

8. History of any acute illness within the past 1 week

9. Subject with febrile illness (axillary temperature >= 37.5 0C) at the time of enrollment

10. Planned or elective surgery during the course of the study

11. History of administration of blood, any blood containing product or immunoglobulins since birth

12. Participation of subject in any clinical trial since birth or participation of subjectâ??s mother in any clinical trial within the past 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified