Hepatitis B Clinical Trial
Official title:
A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age
Verified date | May 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
Status | Completed |
Enrollment | 175 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 42 Days to 64 Days |
Eligibility |
Inclusion Criteria: 1. Male and female subjects = 42 days to = 64 days of age. 2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements Exclusion Criteria: 1. Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study. 2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine. 3. History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component. 4. Administration of parenteral immunoglobulin preparation and/or blood products since birth. |
Country | Name | City | State |
---|---|---|---|
India | Rajarajeshwari Medical College and Hospital | Bangalore | Karnataka |
India | Medical College Kolkata | Kolkatta | West Bengal |
India | Bharathi Vidyapeeth University | Pune | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroprotection rate one month after the last dose of vaccine administration | One month after last vaccination | ||
Secondary | Seroprotection rate and GMCs one month after the last vaccine administration | One month after last vaccination |
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