Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
Phase 4
Completed
- Conditions
- Healthy
- Interventions
- Biological: bOPVBiological: PentabioBiological: IPV
- Registration Number
- NCT03310073
- Lead Sponsor
- PT Bio Farma
- Brief Summary
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit
- Detailed Description
To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
Inclusion Criteria
- Healthy, full term, newborns infants.
- Newborns residing within a relatively short and easily accessible distance (<30 km) from the study clinic(s) and not planning to travel away during the entire study period.
- Infant born after 37 weeks of pregnancy
- Infant weighing 2.5 kg or more at birth (Birth weight > 2.5 kg)
- Healthy newborns, with no history of asphyxia or meconium aspiration.
- 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.
- Mother at least elementary school graduate
Exclusion Criteria
- Child concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of congenital or acquired immunodeficiency (including HIV infection)
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C )
- Newborns requiring hospitalization at birth.
- Infant immunized with non-scheduled bOPV or IPV during trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description bOPV (bivalent OPV Bio Farma) bOPV bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally. The subject received bOPV, Pentabio and IPV according to the study schedule. bOPV (bivalent OPV Bio Farma) Pentabio bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally. The subject received bOPV, Pentabio and IPV according to the study schedule. bOPV (bivalent OPV Bio Farma) IPV bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally. The subject received bOPV, Pentabio and IPV according to the study schedule.
- Primary Outcome Measures
Name Time Method Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3 30 days after the last vaccination Evaluate protectivity
- Secondary Outcome Measures
Name Time Method Percentage of infants with transition of seronegative to seropositive 30 days after the last vaccination Serological response after four doses of bOPV with 1 dose of IPV
Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV 30 days after the last vaccination Geometric Mean Titer (GMT) 30 days after the last vaccination
Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination. Assess the safety of bOPV
Number of serious adverse events (SAE) which occured during the study 30 days after the last vaccination Assess the safety of bOPV
Percentage of infants with increasing antibody titer >= 4 times 30 days after the last vaccination Serological response after four doses of bOPV with 1 dose of IPV
Trial Locations
- Locations (1)
Hasan Sadikin Hospital
🇮🇩Bandung, West Java, Indonesia