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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 10 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

| Intervention/Treatment |
| --- |
|Biological: DTPa-HBV-IPV/Hib vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, Prophylaxis, Haemophilus influenza type b diseases