Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) of M/s Cadila Healthcare Ltd.: Subject will receive three doses (0.5 ml each) of Diphtheria, Tetanus and Pertussis (Who
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion 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 parents or legally acceptable representative 6. Subjectâ??s parents or legally acceptable representative literate enough to fill the diary card
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at day 84Timepoint: 28 days following last vaccination (day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at baseline and at day 84Timepoint: 28 days following last vaccination (day 84) | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Cadila Healthcare Ltd.
Outcome results
None listed