Healthy Clinical Trial
Official title:
Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Verified date | October 2013 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
Status | Completed |
Enrollment | 600 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 11 Weeks |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Indonesia | Garuda Primary Health Center | Bandung | West Java |
Indonesia | Ibrahim Adji Primary Health Center | Bandung | West Java |
Indonesia | Puter Primary Health Center | Bandung | West Java |
Indonesia | Jatinegara Primary Health Center | Jakarta | |
Indonesia | Mampang Prapatan Primary Health Center | Jakarta | |
Indonesia | Tebet Primary Health Center | Jakarta |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | Yes |
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