Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2010-11-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hib/PRP-T vaccine
One dose, correspond to 0.5 ml, composed of:
PRP-T 10ug NaCl 0.85%
Frequency: 1 injection
Hib/PRP-T vaccine
Hib liquid vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hib/PRP-T vaccine
Hib liquid vaccine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PT Bio Farma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kusnandi Rusmil, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine UNPAD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Hib 0110
Identifier Type: -
Identifier Source: org_study_id