Healthy
Conditions
Keywords
DTP-HB-Hib, Pentavalen, Pentabio, Booster
Brief summary
Measure antibody persistence prior to booster administration of Pentabio vaccine.
Detailed description
Number and percentage of children with anti diphtheria, titer and anti tetanus titer \>= 0.01 IU/ml, anti HBs \>=10mIU/ml, anti Hib \>=0.15ug/ml prior to booster administration.
Interventions
BIOLOGICALPentavalen
Batch 5010613
Sponsors
PT Bio Farma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Children, 18-24 months of age * Subjects who had completed the primary series of Pentabio vaccine in the previous trial * Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form * Subject's parents commit to comply with the instruction
Exclusion criteria
* Subjects concomitantly enrolled or scheduled to be enrolled in another trial * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5oC on Day 0) * Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection * Known history of allergy to any component of the vaccines (e.f. formaldehyde) * Known history of acquired immunodeficiency (including HIV infection) * Subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (\>2 weeks) * Subject receives other vaccination within 1 month prior to inclusion * Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives * Infant with a known history of diphtheria, tetanus, pertussis, Hepatitis B and Hib infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geomoteric mean titer prior to booster administration of Pentabio vaccine | visit 1 | The number and percentage of children with anti diphtheria titer and anti tetanus titer \>=0.01 IU/ml anti HBs \>=10 mIU/ml, anti Hib \>=0.15 ug/ml prior to booster administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protectivity of Pentabio vaccine 1 month after the booster dose | 1 month | Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer) |
| Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose | 1 month | Geometric mean titer to diphtheria, tetanus, pertussis, Hepatitis B and Hib before immunization and 1 month after immunization |
| Seroconversion and seroprotection before and 1 month after the booster dose | 1 month | The changes of serological response before and after booster dose |
| Number of participants with adverse events | 1 month | Local and systemic reaction within 28 days after immunization. |
Countries
Indonesia
Outcome results
None listed