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Safety Profile Following Pentabio Vaccination in Indonesian Infants

NCT ID: NCT02093286

Last Updated: 2017-11-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Detailed Description

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Any local and systemic reaction after Pentabio immunization

Conditions

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Healthy

Keywords

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Pentabio Vaccine Safety Infants Booster Dose DTwP/HepB/Hib

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pentabio Vaccine

1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Immunization with Pentabio vaccine
* Parents already understood the consequences to be involved in this study and having signed the informed consent form
* Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization

Exclusion Criteria

* Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.
Minimum Eligible Age

2 Months

Maximum Eligible Age

11 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julitasari Sundoro, MD

Role: PRINCIPAL_INVESTIGATOR

AEFI National Committee

Locations

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West Java Provincial Ministry of Health

Bandung, West Java, Indonesia

Site Status

West Nusa Tenggara Provincial Ministry of Health

Mataram, West Nusa Tenggara, Indonesia

Site Status

Bali Provincial Ministry of Health

Bali, , Indonesia

Site Status

Yogyakarta Provincial Ministry of Health

Yogyakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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PMS Penta 0414

Identifier Type: -

Identifier Source: org_study_id