Safety Profile Following Pentabio Vaccination in Indonesian Infants
Completed
- Conditions
- Healthy
- Registration Number
- NCT02093286
- Lead Sponsor
- PT Bio Farma
- Brief Summary
To assess any serious systemic reaction within 30 minutes after Pentabio immunization
- Detailed Description
Any local and systemic reaction after Pentabio immunization
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4000
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any serious adverse event occurring from inclusion until 30 minutes after the injection 30 minutes local and systemic reaction
- Secondary Outcome Measures
Name Time Method Percentage of local and systemic events occurring within 72 hours after each injection 72 hours any local and systemics events
Percentage of local and systemic events occurring from 72 hours up to 28 days following injection. 25 days any local and systemic events
Percentage of serious adverse events within 28 days after injection 28 days Any serious adverse events
Trial Locations
- Locations (4)
West Nusa Tenggara Provincial Ministry of Health
🇮🇩Mataram, West Nusa Tenggara, Indonesia
Bali Provincial Ministry of Health
🇮🇩Bali, Indonesia
Yogyakarta Provincial Ministry of Health
🇮🇩Yogyakarta, Indonesia
West Java Provincial Ministry of Health
🇮🇩Bandung, West Java, Indonesia