Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DTPa-HBV-IPV/Hib vaccine
DTPa-IPV/Hib vaccine
EngerixTM-B
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for enrolment at birth
- Written informed consent obtained from the parents or guardians of the subject.
- A male or female infant born after a normal gestation period (between 36 and 42 weeks).
- Born to a mother seronegative for HBsAg.
- Free of obvious health problems as established by clinical examination before entering into the study.
Inclusion criteria for administration of the combined vaccine regimen
- Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.
Inclusion criteria for administration of the booster dose
- Between, and including, 15 and 18 months of age at the time of the booster vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Completion of the three-dose primary vaccination course.
Exclusion Criteria:
Exclusion criteria for enrolment at birth
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- Major congenital defect(s).
Exclusion criteria for administration of the combined vaccine regimen
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Exclusion criteria for administration of the booster dose
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination.
- Previous booster vaccination against 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.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period.
- Hypersensitivity reaction due to vaccine in primary course
- Encephalopathy within 7 days of previous vaccination with DTP vaccine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Seroprotective anti-HBs antibody titres above protocol specified cut-off value
Secondary Outcome Measures
Antibody titres against all investigational vaccine antigen components
Occurrence of solicited symptoms
Occurrence of unsolicited symptoms
Occurrence of Serious Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00880477
Brief Title
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
Official Title
Immunogenicity and Safety of GSK Biological's DTPa-HBV-IPV/Hib Vaccine or DTPa-IPV/Hib Co-administered With HBV Vaccine as Primary and Booster Vaccination in Healthy Infants Born to Hepatitis B Surface Antigen Negative Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DTPa-HBV-IPV/Hib vaccine
Intervention Description
Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
Intervention Type
Biological
Intervention Name(s)
DTPa-IPV/Hib vaccine
Intervention Description
Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
Intervention Type
Biological
Intervention Name(s)
EngerixTM-B
Intervention Description
The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.
Primary Outcome Measure Information:
Title
Seroprotective anti-HBs antibody titres above protocol specified cut-off value
Time Frame
At the time of the second dose of combined vaccination, one month after the 3rd dose of combined vaccination and one month after the booster dose.
Secondary Outcome Measure Information:
Title
Antibody titres against all investigational vaccine antigen components
Time Frame
One month after first combined vaccine dose, two months after Dose 1, one month after third combined vaccine dose prior to booster vaccination and one month post-booster vaccination.
Title
Occurrence of solicited symptoms
Time Frame
During the 4-day follow-up period after each dose
Title
Occurrence of unsolicited symptoms
Time Frame
During the 30-day follow-up period after each dose of study vaccine
Title
Occurrence of Serious Adverse Events
Time Frame
From the birth dose of hepatitis B vaccine and ending with the last study visit or performance of the last study procedure or a minimum of 30 days following the third dose of the mixed vaccines and from the start of booster dose and ending a minimum of 3
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:
Inclusion criteria for enrolment at birth
Written informed consent obtained from the parents or guardians of the subject.
A male or female infant born after a normal gestation period (between 36 and 42 weeks).
Born to a mother seronegative for HBsAg.
Free of obvious health problems as established by clinical examination before entering into the study.
Inclusion criteria for administration of the combined vaccine regimen
Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.
Inclusion criteria for administration of the booster dose
Between, and including, 15 and 18 months of age at the time of the booster vaccination.
Written informed consent obtained from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Completion of the three-dose primary vaccination course.
Exclusion Criteria:
Exclusion criteria for enrolment at birth
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
Major congenital defect(s).
Exclusion criteria for administration of the combined vaccine regimen
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
Any chronic drug therapy to be continued during the study period.
Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Exclusion criteria for administration of the booster dose
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination.
Previous booster vaccination against 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.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
History of any neurologic disorders or seizures.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period.
Hypersensitivity reaction due to vaccine in primary course
Encephalopathy within 7 days of previous vaccination with DTP vaccine
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
21741011
Citation
Shao PL, Lu CY, Hsieh YC, Bock HL, Huang LM; Taiwan Infanrix-069 Study Group. Immunogenicity and reactogenicity of DTPa-IPV/Hib vaccine co-administered with hepatitis B vaccine for primary and booster vaccination of Taiwanese infants. J Formos Med Assoc. 2011 Jun;110(6):415-22. doi: 10.1016/S0929-6646(11)60061-2.
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/069
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
217744/069
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
217744/069
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
217744/069
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
217744/069
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 Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
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