Safety of Hib Vaccine (Bio Farma)
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: Hib/PRP-T vaccine
- Registration Number
- NCT01977170
- Lead Sponsor
- PT Bio Farma
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hib/PRP-T vaccine Hib/PRP-T vaccine One dose, correspond to 0.5 ml, composed of: PRP-T 10ug NaCl 0.85% Frequency: 1 injection
- Primary Outcome Measures
Name Time Method Incidence rate of adverse event of Hib vaccine (Bio Farma) 30 minutes Local and systemic reactions
- Secondary Outcome Measures
Name Time Method Incidence rate of adverse event of Hib vaccine (Bio Farma) 28 hours, 48 hours, 72 hours, 28 days Local and systemic reaction
To evaluate the antibody function serum using serum bactericidal activities test 28 days Presence of serum of bactericidal activities after immunization.
Trial Locations
- Locations (1)
Hasan Sadikin Hospital
🇮🇩Bandung, West Java, Indonesia