Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
NCT ID: NCT01470287
Last Updated: 2017-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
175 participants
INTERVENTIONAL
2011-12-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Arm 1
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
42 Days
64 Days
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Locations
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Rajarajeshwari Medical College and Hospital
Bangalore, Karnataka, India
Bharathi Vidyapeeth University
Pune, Maharashtra, India
Medical College Kolkata
Kolkata, West Bengal, India
Countries
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References
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Eregowda A, Lalwani S, Chatterjee S, Vakil H, Ahmed K, Costantini M, Lattanzi M. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants. Hum Vaccin Immunother. 2013 Sep;9(9):1903-9. doi: 10.4161/hv.25166. Epub 2013 Jun 19.
Other Identifiers
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V66_05
Identifier Type: -
Identifier Source: org_study_id
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