Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine

Study Overview
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Brief Summary
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Measure antibody persistence prior to booster administration of Pentabio vaccine.

Detailed Description
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Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01 IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.

Official Title
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Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age

Conditions
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Healthy

Intervention / Treatment
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* Biological: Pentavalen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children, 18-24 months of age Subjects who had completed the primary series of Pentabio vaccine in the previous trial Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form Subject's parents commit to comply with the instruction Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another trial Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC on Day 0) Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection Known history of allergy to any component of the vaccines (e.f. formaldehyde) Known history of acquired immunodeficiency (including HIV infection) Subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (>2 weeks) Subject receives other vaccination within 1 month prior to inclusion Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives Infant with a known history of diphtheria, tetanus, pertussis, Hepatitis B and Hib infection

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 24 Months

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentavalen<br>Pentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly | Biological: Pentavalen<br>* Batch 5010613<br>* Other names: DPT-HB-Hib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geomoteric mean titer prior to booster administration of Pentabio vaccine | The number and percentage of children with anti diphtheria titer and anti tetanus titer >=0.01 IU/ml anti HBs >=10 mIU/ml, anti Hib >=0.15 ug/ml prior to booster administration. | visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protectivity of Pentabio vaccine 1 month after the booster dose | Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer) | 1 month | 
| Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose | Geometric mean titer to diphtheria, tetanus, pertussis, Hepatitis B and Hib before immunization and 1 month after immunization | 1 month | 
| Seroconversion and seroprotection before and 1 month after the booster dose | The changes of serological response before and after booster dose | 1 month | 
| Number of participants with adverse events | Local and systemic reaction within 28 days after immunization. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTP-HB-Hib, Pentavalen, Pentabio, Booster