Healthy
Conditions
Keywords
Pentabio Vaccine, Safety, Infants, Booster Dose, DTwP/HepB/Hib
Brief summary
To assess any serious systemic reaction within 30 minutes after Pentabio immunization
Detailed description
Any local and systemic reaction after Pentabio immunization
Interventions
None listed
Sponsors
PT Bio Farma
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 11 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any serious adverse event occurring from inclusion until 30 minutes after the injection | 30 minutes | local and systemic reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed