Clinical trial NCT03310073: Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 143
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3
timeFrame: 30 days after the last vaccination
Secondary outcomes:
measure: Percentage of infants with increasing antibody titer >= 4 times
timeFrame: 30 days after the last vaccination
measure: Percentage of infants with transition of seronegative to seropositive
timeFrame: 30 days after the last vaccination
measure: Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV
timeFrame: 30 days after the last vaccination
measure: Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV
timeFrame: first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination.
measure: Number of serious adverse events (SAE) which occured during the study
timeFrame: 30 days after the last vaccination
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
Study officials:
affiliation: Hasan Sadikin General Hospital
name: Kusnandi Rusmil
role: PRINCIPAL_INVESTIGATOR
References: