Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
NCT01470287 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175
Last updated 2017-05-19
Summary
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
Conditions
- Diphtheria
- Tetanus
- Pertussis
- Hepatitis B
- Hemophilus Influenzae B
Interventions
- BIOLOGICAL
-
DTwP-HepB-Hib Vaccine
Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.
Sponsors & Collaborators
-
Novartis Vaccines
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 42 Days
- Max Age
- 64 Days
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-12-31
- Primary Completion
- 2012-04-30
- Completion
- 2012-04-30
Countries
- India
Study Locations
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