Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
NCT ID: NCT03310073
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
143 participants
INTERVENTIONAL
2016-07-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
bOPV
Batch Number: 2042015
Pentabio
Batch number: 5050115 The vaccine shall be given intramuscularly.
IPV
The vaccine shall be given intramuscularly.
Interventions
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bOPV
Batch Number: 2042015
Pentabio
Batch number: 5050115 The vaccine shall be given intramuscularly.
IPV
The vaccine shall be given intramuscularly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Minute
1 Day
ALL
Yes
Sponsors
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PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Kusnandi Rusmil
Role: PRINCIPAL_INVESTIGATOR
Hasan Sadikin General Hospital
Locations
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Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Countries
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Other Identifiers
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bOPV 0416
Identifier Type: -
Identifier Source: org_study_id