Trial | NCT01977170  Report issue

Title

Safety of Hib Vaccine (Bio Farma)
Phase 1 Study of Hib Vaccine (Bio Farma)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    25
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.
Study Started
Nov 30
2010
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Nov 06
2013
Estimate

Biological Hib/PRP-T vaccine

Hib liquid vaccine

Hib/PRP-T vaccine Experimental

One dose, correspond to 0.5 ml, composed of: PRP-T 10ug NaCl 0.85% Frequency: 1 injection

Criteria 

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
No Results Posted