Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

Study Overview
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Brief Summary
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The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.

Detailed Description
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This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.

Official Title
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Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

Conditions
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Healthy

Intervention / Treatment
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* Biological: DTP/HB/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 Mother at least graduate from elementary school Received Hepatitis B vaccine (Bio Farma) at birth 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 weeks) Other vaccination within the 1 month 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTP/HB/Hib Vaccine (Batch: A)<br>Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal | Biological: DTP/HB/Hib Vaccine<br>* DPT/HB/Hib vaccine (Bio Farma)<br>* Other names: Pentavalent;|
| Experimental: DTP/HB/Hib vaccine (Batch: B)<br>Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal | Biological: DTP/HB/Hib Vaccine<br>* DPT/HB/Hib vaccine (Bio Farma)<br>* Other names: Pentavalent;|
| Experimental: DTP/HB/Hib vaccine (Batch: C)<br>Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal | Biological: DTP/HB/Hib Vaccine<br>* DPT/HB/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 |
| --- | --- | --- |
| Protectivity of DTP/HB/Hib (Bio Farma) vaccine | Number and percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHBs titer >=10mlIU/ml, and antiHib titer >= 0,15ug/ml 28 days after the last injection | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to diphtheria between groups (three different batch numbers) | Serological response to Diphteria toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=0.1 IU/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive | 4 months | 
| Antibody response to Tetanus between groups (three different batch numbers) | Serological response to Tetanus toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=0.1 IU/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive | 4 months | 
| Antibody response to Pertussis component between groups (three different batch numbers) | Serological response to Pertussis component (agglutinins): GMT,percentage of infants with titre >=40, >=80,>=160 and >=320 (1/dil.), percentage of infants with increasing antibody titer >=4 times. | 4 months | 
| Antibody response to Hepatitis B between groups (three different batch numbers) | Serological response to Hepatitis B: Geometric mean of anti-HBs,percentage of infants with titer >=10mlIU/ml, percentage of infants with increasing antibody titer >=4 times and/ or percentage of infants with transition of seronegative to seropositive. | 4 months | 
| Antibody response to Hib/PRP between groups (three different batch numbers) | Serological response to Hib/PRP: GMT, percentage of infants with titre >=1ug/ml and >=0.15ug/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive | 4 months | 
| Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups | Number and percentage of local reaction and systemic events following vaccination. | 30 minutes, 72 hours, 28 days after immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined pentavalent DTP/HB/Hib vaccine, Infants, Primary vaccination