Immunogenicity, Safety
Conditions
Brief summary
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
Detailed description
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
Interventions
BIOLOGICALRecombinant Hepatitis B + DTP-HB-Hib
1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib
BIOLOGICALHep B + Pentabio (registered)
1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product
Intervention model description
Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study
Eligibility
Sex/Gender
ALL
Age
0 Days to 3 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy, full term, newborns infants. * Infant born after 37-42 weeks of pregnancy. * Infant weighing 2500 gram or more at birth. * Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. * Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
Exclusion criteria
* Child concomitantly enrolled or scheduled to be enrolled in another trial. * Mother with HBsAg positive. * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>37.5C on Day 0). * Suspected of allergy to any component of the vaccines (e.g. formaldehyde). * Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * Newborn suspected of congenital or acquired immunodeficiency (including HIV infection). * Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)). * Received other vaccination 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 objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk | 28 days after immunization | Percentage of infants with anti-diphtheria titer and anti-tetanus titer \> 0.01 IU/ml, anti HbsAg titer \> 10 mIU/ml, and anti PRP-T titer \> 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria | 28 days after immunization | Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer \> 0.01 IU/ml, \> 0.1 IU/ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive |
| Serological response to the pertussis component (agglutinins) | 28 days after immunization | Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer \> 40, \> 80, \> 160 and \> 320 (1/dil.), percentage of infants with increasing antibody titer \> 4 times |
| Geometric mean of anti-HbsAg | 28 days after immunization | Geometric mean of anti-HbsAg, percentage of infants with titer \> 10mIU/ml, percentage of infants with increasing antibody titer \> 4 times and/ or percentage of infants with transition of seronegative to seropositive |
| Serological response to Hib/PRP | 28 days after immunization | Serological response to Hib/PRP: GMT, percentage of infants with titer \>1 ug /ml ; \> 0.15 ug /ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive |
| Seroconversion | 28 days after immunization | Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \> 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control. |
Countries
Indonesia
Outcome results
None listed