The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

Study Overview
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Brief Summary
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The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed Description
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This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Official Title
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Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine

Conditions
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Healthy

Intervention / Treatment
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* Biological: DPT/HepatitisB/Hib vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant 6-11 week of age Infant born after 37-42 week of pregnancy Infant weighting more than 2.5 kg at birth Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial Exclusion Criteria: Child concomitantly enroll or schedule to be enroll in another trial Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0) Known history of allergy to any component of the vaccine component (e.g.formaldehyde) History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection Known history of congenital or acquired immunodeficiency (including HIV infection) Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu) Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 11 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTP/HepatitisB/Hib vaccine<br>Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal | Biological: DPT/HepatitisB/Hib vaccine<br>* DPT/HepatitisB/Hib vaccine (Bio Farma)<br>* Other names: Pentavalent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma) | Local and systemic reactions | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma) | Local and systemic reaction | 28 hours, 48 hours, 72 hours, 28 days | 
| To asses the immunogenicity | Percentage of infants with increasing antibody | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTB/HB/Hib vaccine, Infants, Phase I