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

November 6, 2017 updated by: PT Bio Farma

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

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

Study Overview

Status

Completed

Conditions

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

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Hasan Sadikin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: bOPV (bivalent OPV Bio Farma)

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.

Batch Number: 2042015
Other Names:
  • bivalent Oral Polio Vaccine
Batch number: 5050115 The vaccine shall be given intramuscularly.
Other Names:
  • DTP-HB-Hib Vaccine
The vaccine shall be given intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3
Time Frame: 30 days after the last vaccination
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
Time Frame: 30 days after the last vaccination
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
Time Frame: 30 days after the last vaccination
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
Time Frame: 30 days after the last vaccination
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
Time Frame: first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination.
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
Time Frame: 30 days after the last vaccination
Assess the safety of bOPV
30 days after the last vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Kusnandi Rusmil, Hasan Sadikin General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (ACTUAL)

October 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • bOPV 0416

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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