Back to resultsImmunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
DTwP-HepB-Hib Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Infants,, Immunogenicity,, Safety
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects ≥ 42 days to ≤ 64 days of age.
- 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:
- Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
- History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
- History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
- Administration of parenteral immunoglobulin preparation and/or blood products since birth.
Sites / Locations
- Rajarajeshwari Medical College and Hospital
- Bharathi Vidyapeeth University
- Medical College Kolkata
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Seroprotection rate one month after the last dose of vaccine administration
Secondary Outcome Measures
Seroprotection rate and GMCs one month after the last vaccine administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01470287
Brief Title
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae B
Keywords
Infants,, Immunogenicity,, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DTwP-HepB-Hib Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seroprotection rate one month after the last dose of vaccine administration
Time Frame
One month after last vaccination
Secondary Outcome Measure Information:
Title
Seroprotection rate and GMCs one month after the last vaccine administration
Time Frame
One month after last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
64 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects ≥ 42 days to ≤ 64 days of age.
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:
Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
Administration of parenteral immunoglobulin preparation and/or blood products since birth.
Facility Information:
Facility Name
Rajarajeshwari Medical College and Hospital
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Bharathi Vidyapeeth University
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Medical College Kolkata
City
Kolkatta
State/Province
West Bengal
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
23783081
Citation
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.
Results Reference
derived
Learn more about this trial
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
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