Safety of Hib Vaccine (Bio Farma)

Phase 1 Study of Hib Vaccine (Bio Farma)

The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Inclusion Criteria:

• Adult (age 18 - 40 years old)
• Provision of written informed consent
• Good health according to the clinical investigator
• Willingness and ability to adhere to the regimen of the study

Exclusion Criteria:

• Known not enrolled in other study
• Pregnancy or lactation
• Known or suspected allergy to any of the vaccine component (by medical history)
• History of unusual reaction to any previous vaccination
• Known or suspected immune deficiency, or use of medication that may influence the immune system
• Prior respiratory infection
• Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study
• Acute febrile illness (temperature > 37.5 Celsius)
• Present evidence of serious diseases demanding medical treatment
• Any significant congenital or chronic disorder