Healthy
Conditions
Keywords
DTB/HB/Hib vaccine, Infants, Phase I
Brief summary
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
Detailed description
This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
Interventions
BIOLOGICALDPT/HepatitisB/Hib vaccine
DPT/HepatitisB/Hib vaccine (Bio Farma)
Sponsors
PT Bio Farma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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
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 minggu) * 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 |
|---|---|---|
| Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma) | 30 minutes | Local and systemic reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma) | 28 hours, 48 hours, 72 hours, 28 days | Local and systemic reaction |
| To asses the immunogenicity | 28 days | Percentage of infants with increasing antibody |
Countries
Indonesia
Outcome results
None listed