HealthyPhase 1NCT01977170
Safety of Hib Vaccine (Bio Farma)
A Phase 1 study testing Hib/PRP-T vaccine in people with Healthy, run by PT Bio Farma at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hib/PRP-T vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Hib/PRP-T vaccine
- Keywords
- Adults, Hib vaccines, Immunogenicity, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hib/PRP-T vaccineBiological
Hib liquid vaccine
| Study group | Role | What they receive |
|---|---|---|
| Hib/PRP-T vaccine | Experimental | One dose, correspond to 0.5 ml, composed of:
PRP-T 10ug NaCl 0.85%
Frequency: 1 injection Receives: Biological: Hib/PRP-T vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse event of Hib vaccine (Bio Farma)
Local and systemic reactions
Measured: 30 minutes
Secondary outcomes (2)
To evaluate the antibody function serum using serum bactericidal activities test
Presence of serum of bactericidal activities after immunization.
Measured: 28 days
Incidence rate of adverse event of Hib vaccine (Bio Farma)
Local and systemic reaction
Measured: 28 hours, 48 hours, 72 hours, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kusnandi Rusmil, PhD, Principal investigator, Faculty of Medicine UNPAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977170
- Sponsor's protocol ID
- Hib 0110
- Status last verified
- Oct 2013
- First submitted
- 29 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Hib Vaccine (Bio Farma)
- ClinicalTrials.gov ID
- NCT01977170
- Acronym / sponsor ID
- Hib 0110
- Conditions
- Healthy
- Keywords
- Adults, Hib vaccines, Immunogenicity, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hib/PRP-T vaccine | Experimental | Biological: Hib/PRP-T vaccineOne dose, correspond to 0.5 ml, composed of: PRP-T 10ug NaCl 0.85% Frequency: 1 injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hib/PRP-T vaccineHib liquid vaccine | Biological | Hib/PRP-T vaccine |
Primary outcome
Incidence rate of adverse event of Hib vaccine (Bio Farma)
Time frame: 30 minutes
Local and systemic reactions
2 secondary outcomes
To evaluate the antibody function serum using serum bactericidal activities test
Time frame: 28 days
Incidence rate of adverse event of Hib vaccine (Bio Farma)
Time frame: 28 hours, 48 hours, 72 hours, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kusnandi Rusmil, PhD principal investigator
Faculty of Medicine UNPAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hib/PRP-T vaccine in people with Healthy, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of adverse event of Hib vaccine (Bio Farma) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.