Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine

Study Overview
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Brief Summary
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The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.

Detailed Description
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This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.

Official Title
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Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants

Conditions
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Healthy

Intervention / Treatment
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* Biological: DTP/HB/Hib vaccine
* Biological: DTP/HB and 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 weighing 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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTP/HB/Hib vaccine<br>Group A will receive DTP/HB/Hib combination vaccine at 6-11, 10-15 and 14-19 weeks of age. DTP/HB/Hib component: Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal | Biological: DTP/HB/Hib vaccine<br>* Dosage equal to 0.5 mL administered intramuscularly<br>* Other names: Pentavalent;|
| Active Comparator: DTP/HB and Hib vaccine<br>Group B will receive DTP/HB and Hib Vaccines separately at 6-11,10-15, 14-19 weeks of age DTP/HB component: Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis rHbsAg Aluminum phosphate Natrium Chloride Thimerosal Hib component: Purified Haemophilus influenzae type b polysaccharide 10 mcg | Biological: DTP/HB and Hib vaccine<br>* Dosage equal to 0.5 mL administered intramuscularly<br>|

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 | Percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHbs titer >=10mlIU/ml, and antiPRP-TT titer >= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to diphteria toxoid in both group | 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 Toxoid in both group | 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 in both group | Serological response to the 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 in both group | 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 PRP-T in both group | 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/Hepatitis B/Hib vaccine (Bio Farma) | Local and systemic reaction | 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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DTP/HB/Hib vaccine, Immunogenicity, Infants, Safety