Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV

Study Overview
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Brief Summary
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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
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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

Official Title
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Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants

Conditions
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Healthy

Intervention / Treatment
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* Biological: bOPV
* Biological: Pentabio
* Biological: IPV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bOPV (bivalent OPV Bio Farma)<br>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. | Biological: bOPV<br>* Batch Number: 2042015<br>* Other names: bivalent Oral Polio Vaccine;Biological: Pentabio<br>* Batch number: 5050115 The vaccine shall be given intramuscularly.<br>* Other names: DTP-HB-Hib Vaccine;Biological: IPV<br>* The vaccine shall be given intramuscularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3 | Evaluate protectivity | 30 days after the last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of infants with increasing antibody titer >= 4 times | Serological response after four doses of bOPV with 1 dose of IPV | 30 days after the last vaccination | 
| Percentage of infants with transition of seronegative to seropositive | Serological response after four doses of bOPV with 1 dose of IPV | 30 days after the last vaccination | 
| Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV | Geometric Mean Titer (GMT) 30 days after the last vaccination | 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 | Assess the safety of bOPV | first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination. | 
| Number of serious adverse events (SAE) which occured during the study | Assess the safety of bOPV | 30 days after the last vaccination |