Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
Primary Purpose
Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DTPa-HBV-IPV/Hib (Infanrix hexa™)
OPV
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.
- Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion Criteria:
The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination).
- Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of seizures or of any neurological disease at study entry.
- Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
- Acute disease at the time of enrolment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group A
Arm Description
Outcomes
Primary Outcome Measures
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Secondary Outcome Measures
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Number of subjects with solicited and unsolicited adverse events
Number of subjects with serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01457560
Brief Title
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
Official Title
Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
April 2001 (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 and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis
Keywords
Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DTPa-HBV-IPV/Hib (Infanrix hexa™)
Intervention Description
Three doses administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
OPV
Intervention Description
One dose administered orally
Primary Outcome Measure Information:
Title
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Time Frame
One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
Secondary Outcome Measure Information:
Title
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
Time Frame
Before the first dose ( Month 0 )
Title
Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
Time Frame
Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
Title
Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
Time Frame
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Title
Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
Time Frame
One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
Title
Number of subjects with solicited and unsolicited adverse events
Time Frame
After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
Title
Number of subjects with serious adverse events
Time Frame
During the study period (Month 0 to Month 9)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.
Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion Criteria:
The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination).
Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of seizures or of any neurological disease at study entry.
Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
Acute disease at the time of enrolment.
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
22349525
Citation
Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.
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
217744/060
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
217744/060
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
217744/060
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
217744/060
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
217744/060
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 DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
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