Healthy
Conditions
Keywords
DTP/HB/Hib vaccine, Immunogenicity, Infants, Safety
Brief summary
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
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.
Interventions
BIOLOGICALDTP/HB/Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly
BIOLOGICALDTP/HB and Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protectivity of DTP/HB/Hib (Bio Farma) vaccine | 4 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody response to Tetanus Toxoid in both group | 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 in both group | 4 months | 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. |
| Antibody response to diphteria toxoid in both group | 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 PRP-T in both group | 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/Hepatitis B/Hib vaccine (Bio Farma) | 30 minutes, 72 hours, 28 days after immunization | Local and systemic reaction |
| Antibody response to Hepatitis B in both group | 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