Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Primary Purpose
Diphtheria, Poliomyelitis, Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pediarix TM, Infanrix penta TM
Hiberix TM
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria
Eligibility Criteria
Inclusion Criteria:
- A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- Major congenital defects
- Serious chronic illness
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group
Arm Description
Outcomes
Primary Outcome Measures
Anti-PT, anti-FHA and anti-PRN antibody titers.
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
Anti-HBs antibody titers
Anti-polio virus types 1, 2 and 3 antibody titers
Anti-PRP antibody titers
Secondary Outcome Measures
Occurrence of solicited adverse events
Occurrence of unsolicited adverse events
Occurrence of Serious Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00879827
Brief Title
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Official Title
Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
May 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Poliomyelitis, Hepatitis B, Tetanus, Acellular Pertussis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pediarix TM, Infanrix penta TM
Intervention Description
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Intervention Type
Biological
Intervention Name(s)
Hiberix TM
Intervention Description
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Primary Outcome Measure Information:
Title
Anti-PT, anti-FHA and anti-PRN antibody titers.
Time Frame
One month after the 3rd dose of the primary vaccination course
Title
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
Time Frame
One month after the 3rd dose of the primary vaccination course
Title
Anti-HBs antibody titers
Time Frame
One month after the 3rd dose of the primary vaccination course
Title
Anti-polio virus types 1, 2 and 3 antibody titers
Time Frame
One month after the 3rd dose of the primary vaccination course
Title
Anti-PRP antibody titers
Time Frame
One month after the 3rd dose of the primary vaccination course
Secondary Outcome Measure Information:
Title
Occurrence of solicited adverse events
Time Frame
During the 4-day follow-up period after each dose
Title
Occurrence of unsolicited adverse events
Time Frame
During the 30-day follow-up period after each dose
Title
Occurrence of Serious Adverse Events
Time Frame
Over the course of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the parents or guardians of the subject.
Born after a normal gestation period (between 36 and 42 weeks).
Exclusion Criteria:
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
Major congenital defects
Serious chronic illness
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Acute disease at the time of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
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.
Citations:
PubMed Identifier
21621155
Citation
Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group; Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.
Results Reference
background
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
217744/049
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
217744/049
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
217744/049
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
217744/049
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
217744/049
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
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