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NCT02093286 Clinical Trial

Safety Profile Following Pentabio Vaccination in Indonesian Infants

Healthy Clinical Trial

Official title:
Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02093286
Other study ID # PMS Penta 0414
Secondary ID
Status Completed
Phase N/A
First received March 19, 2014
Last updated November 1, 2017
Start date May 2014
Est. completion date December 2014

Study information
Verified date December 2014
Source PT Bio Farma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

Any local and systemic reaction after Pentabio immunization

Recruitment information / eligibility
Status Completed
Enrollment 4000
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 11 Months
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia Bali Provincial Ministry of Health Bali
Indonesia West Java Provincial Ministry of Health Bandung West Java
Indonesia West Nusa Tenggara Provincial Ministry of Health Mataram West Nusa Tenggara
Indonesia Yogyakarta Provincial Ministry of Health Yogyakarta

Sponsors (1)
Lead Sponsor Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Any serious adverse event occurring from inclusion until 30 minutes after the injection local and systemic reaction 30 minutes
Secondary Percentage of local and systemic events occurring within 72 hours after each injection any local and systemics events 72 hours
Secondary Percentage of local and systemic events occurring from 72 hours up to 28 days following injection. any local and systemic events 25 days
Secondary Percentage of serious adverse events within 28 days after injection Any serious adverse events 28 days
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