Safety of Hib Vaccine (Bio Farma)

Phase 1 Study of Hib Vaccine (Bio Farma)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01977170

Enrollment

Registered

2013-11-06

Start date

2010-11-30

Completion date

2010-12-31

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Adults, Hib vaccines, Immunogenicity, Safety

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.

Interventions

BIOLOGICALHib/PRP-T vaccine

Hib liquid vaccine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence rate of adverse event of Hib vaccine (Bio Farma)	30 minutes	Local and systemic reactions

Secondary

Measure	Time frame	Description
To evaluate the antibody function serum using serum bactericidal activities test	28 days	Presence of serum of bactericidal activities after immunization.
Incidence rate of adverse event of Hib vaccine (Bio Farma)	28 hours, 48 hours, 72 hours, 28 days	Local and systemic reaction

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026