Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Diphtheria, Tetanus, Pertussis (Whole Cell),
Hepatitis B (rDNA) and Haemophilus influenzae
Type b Conjugate Vaccine (Adsorbed) I.P. of M/s
Cadila Healthcare Ltd.: The subjects will rece
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 parent 6.Subjectâ??s parent literate enough to fill the diary card
Exclusion criteria
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 11.History of administration of blood, any blood 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, anti-pertussis, anti-HBs and anti-PRP antibodies at the end of the studyTimepoint: 28 days post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibodies at the baseline and at the end of the studyTimepoint: 28 days post-vaccination;Local and systemic adverse eventsTimepoint: Throughout study duration;Overall tolerability evaluationTimepoint: 28 days post-vaccination;Serious adverse eventsTimepoint: Throughout study duration | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Cadila Healthcare Ltd., Ahmedabad
Outcome results
None listed