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

PT Bio Farma

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Biological: bOPV; Biological: IPV; Biological: Pentabio

Study type: Interventional

Funder types: Industry

Identifiers

NCT03310073

bOPV 0416

Details and patient eligibility

About

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

Full 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

Enrollment: 143 patients

Sex: All

Ages: 1 minute to 1 day old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 1 patient group

bOPV (bivalent OPV Bio Farma)

Experimental group

Description:

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.

Treatment:

Biological: Pentabio

Biological: bOPV

Biological: IPV