Safety of Hib Vaccine (Bio Farma)

PT Bio Farma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Hib/PRP-T vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01977170

Hib 0110

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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