Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine
- Conditions
- Healthy
- Interventions
- Biological: Pentavalen
- Registration Number
- NCT02095314
- Lead Sponsor
- PT Bio Farma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pentavalen Pentavalen Pentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (6)
Tebet Primary Health Center
🇮🇩Jakarta, Indonesia
Puter Primary Health Centre
🇮🇩Bandung, West Java, Indonesia
Garuda Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Mampang Prapatan Primary Health Center
🇮🇩Jakarta, Indonesia
Ibrahim Adjie Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Jatinegara Primary Health Center
🇮🇩Jakarta, Indonesia