Healthy
Conditions
Keywords
Combined pentavalent DTP/HB/Hib vaccine, Infants, Primary vaccination
Brief summary
The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
Detailed description
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.
Interventions
BIOLOGICALDTP/HB/Hib Vaccine
DPT/HB/Hib vaccine (Bio Farma)
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 11 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protectivity of DTP/HB/Hib (Bio Farma) vaccine | 4 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody response to Tetanus between groups (three different batch numbers) | 4 months | 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 |
| Antibody response to Pertussis component between groups (three different batch numbers) | 4 months | 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. |
| Antibody response to diphtheria between groups (three different batch numbers) | 4 months | 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 |
| Antibody response to Hib/PRP between groups (three different batch numbers) | 4 months | 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 |
| Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups | 30 minutes, 72 hours, 28 days after immunization | Number and percentage of local reaction and systemic events following vaccination. |
| Antibody response to Hepatitis B between groups (three different batch numbers) | 4 months | 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. |
Countries
Indonesia
Outcome results
None listed