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Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

Primary Purpose

Diphtheria, Acellular Pertussis, Tetanus

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
DTPa-HBV-IPV/Hib vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, Prophylaxis, Haemophilus influenza type b diseases

Eligibility Criteria

6 Weeks - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject. Born after a normal gestation period (between 36 and 42 weeks). Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate. Exclusion Criteria: Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose. Any chronic drug therapy to be continued during the study period. Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements). Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases. Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers

Secondary Outcome Measures

1M post-dose 3, antibody levels against all antigens
After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Serious adverse events (SAEs) for entire study

Full Information

First Posted
February 21, 2006
Last Updated
September 27, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00316147
Brief Title
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Official Title
Phase IIIb, Open, Randomized, Multicenter Study to Assess the Immunogenicity & Safety of GSK Biologicals' Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age
Detailed Description
DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 & Haemophilus influenzae type b vaccine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis
Keywords
diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, Prophylaxis, Haemophilus influenza type b diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
DTPa-HBV-IPV/Hib vaccine
Primary Outcome Measure Information:
Title
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
Secondary Outcome Measure Information:
Title
1M post-dose 3, antibody levels against all antigens
Title
After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Title
Serious adverse events (SAEs) for entire study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject. Born after a normal gestation period (between 36 and 42 weeks). Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate. Exclusion Criteria: Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose. Any chronic drug therapy to be continued during the study period. Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements). Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases. Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
GSK Investigational Site
City
Baroda
ZIP/Postal Code
390 001
Country
India
Facility Name
GSK Investigational Site
City
Goa
ZIP/Postal Code
403202
Country
India
Facility Name
GSK Investigational Site
City
New Delhi
ZIP/Postal Code
110002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104005
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104005
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104005
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104005
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104005
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104005
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

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