Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: DTPa-HBV-IPV/Hib vaccine
* Biological: DTPa-IPV/Hib vaccine
* Biological: EngerixTM-B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: DTPa-HBV-IPV/Hib vaccine<br>* 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.<br>|
| Experimental: Group B<br> | Biological: DTPa-IPV/Hib vaccine<br>* 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.<br>Biological: EngerixTM-B<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotective anti-HBs antibody titres above protocol specified cut-off value |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titres against all investigational vaccine antigen components |  | 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. | 
| Occurrence of solicited symptoms |  | During the 4-day follow-up period after each dose | 
| Occurrence of unsolicited symptoms |  | During the 30-day follow-up period after each dose of study vaccine | 
| Occurrence of Serious Adverse Events |  | 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 |