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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310073
• Other study ID #: bOPV 0416
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2017
• Last updated: November 6, 2017
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2017
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• bOPV
Batch Number: 2042015
• Pentabio
Batch number: 5050115 The vaccine shall be given intramuscularly.
• IPV
The vaccine shall be given intramuscularly.

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin Hospital	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with anti polio titer = 8 for type 1, 2 and type 3	Evaluate protectivity	30 days after the last vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Number of serious adverse events (SAE) which occured during the study	Assess the safety of bOPV	30 days after the last vaccination