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OpenTrials
Completed

NCT Number: NCT01977170

Safety of Hib Vaccine (Bio Farma)

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hib/PRP-T vaccine

Biological

Hib liquid vaccine

Primary outcomes

  1. Incidence rate of adverse event of Hib vaccine (Bio Farma)

    Time frame: 30 minutes

    Local and systemic reactions

Secondary outcomes

  1. To evaluate the antibody function serum using serum bactericidal activities test

    Time frame: 28 days

    Presence of serum of bactericidal activities after immunization.

  2. Incidence rate of adverse event of Hib vaccine (Bio Farma)

    Time frame: 28 hours, 48 hours, 72 hours, 28 days

    Local and systemic reaction

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

Phase 1 Study of Hib Vaccine (Bio Farma)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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