Safety of Hib Vaccine (Bio Farma)

Healthy Clinical Trial

Official title:

Phase 1 Study of Hib Vaccine (Bio Farma)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977170
• Other study ID #: Hib 0110
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2013
• Last updated: November 5, 2013
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2013
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Hib/PRP-T vaccine
Hib liquid vaccine

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin Hospital	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of adverse event of Hib vaccine (Bio Farma)	Local and systemic reactions	30 minutes	Yes
Secondary	To evaluate the antibody function serum using serum bactericidal activities test	Presence of serum of bactericidal activities after immunization.	28 days	No
Secondary	Incidence rate of adverse event of Hib vaccine (Bio Farma)	Local and systemic reaction	28 hours, 48 hours, 72 hours, 28 days	Yes