- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310073
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
Intervention / Treatment
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:
Batch number: 5050115 The vaccine shall be given intramuscularly.
Other Names:
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
Additional Relevant MeSH Terms
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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