CTRI/2017/11/010427
Active, not recruiting
Phase 2
A prospective, randomized, two-arm, single-blind, parallel, active-controlled, multicenter, non-inferiority clinical study to evaluate the immunogenicity and safety of Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) of M/s Cadila Healthcare Limited compared to Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) of M/s Panacea Biotec Limited in healthy infants - None
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Sponsor
- Cadila Healthcare Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 parent
- •6\.Subjectâ??s parent literate enough to fill the diary card
Exclusion Criteria
- •1\.Any vaccination before enrollment except vaccination given at birth such as BCG vaccine, Hepatitis\-B vaccine and oral polio vaccine
- •2\.Past history of diphtheria, tetanus, pertussis, hepatitis B or Haemophilus influenzae type b
- •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\.5oC) at the time of Enrollment
- •10\.Planned or elective surgery during the course of the study
Outcomes
Primary Outcomes
Not specified
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