Healthy
Conditions
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
Interventions
Sponsors
PT Bio Farma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 1 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3 | 30 days after the last vaccination | Evaluate protectivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Indonesia
Outcome results
None listed