HealthyPhase 2/3NCT02093260
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
A Phase 2/3 study testing Vaccine in people with Healthy, run by PT Bio Farma at 2 sites in Indonesia.
Trial summary
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study) Read more about this study
- Who is it for?
- Ages 6 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 2 sitesIndonesia
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 2/3
- 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 6 months to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Parents have been informed properly regarding the study and signed the informed consent form
- Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature >=37oC)
- Known history of allergy to egg and/or chicken protein or any other component of the vaccines
- Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (>2 weeks)).
- Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.
- Subjects has been immunized with influenza vaccine within 1 year
- Subjects receives any vaccination within 1 months before and after immunization of Flubio.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Jatinegara Primary Health Center
Jakarta, Jakarta Special Capital Region
Primary School of SDN 01 Kampung Melayu
Jakarta, Jakarta Special Capital Region
About this study
Official title: Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Read the detailed description
Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
- Conditions
- Healthy
- Being tested
- Vaccine
- Keywords
- Flubio Vaccine (Influenza HA), Infants, Children, Safety, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineBiological
Also called Flubio
Flubio (Influenza HA) Vaccine
The vaccine will be given intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Vaccine
Flubio (Influenza HA) vaccine
2 doses for infants and children (6 months - 8 years old)
1 doses for children (9-11 years old)
The vaccine will be given intramuscularly Receives: Biological: Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)
Percentage of subjects with anti HI titer >=1:40
Measured: 2 months
Secondary outcomes (3)
To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)
Percentage subjects with increasing antibody titer >=4 times
Measured: 2 months
To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)
Percentage of subjects with transition of seronegative to seropositive
Measured: 1 months
To asses the safety of Flubio vaccine
Local and Systemic Reaction following immunization
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernie Endyarni, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093260
- Sponsor's protocol ID
- Influenza 0213
- Status last verified
- Apr 2015
- First submitted
- 19 Mar 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Soedjatmiko S, Medise BE, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Bachtiar NS, Sari RM. Immunogenicity and safety of a Trivalent Influenza HA vaccine in Indonesian infants and children. Vaccine. 2018 Apr 12;36(16):2126-2132. doi: 10.1016/j.vaccine.2018.02.114. Epub 2018 Mar 16.
PubMed 29551225
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
- ClinicalTrials.gov ID
- NCT02093260
- Acronym / sponsor ID
- Influenza 0213
- Conditions
- Healthy
- Keywords
- Flubio Vaccine (Influenza HA), Infants, Children, Safety, Immunogenicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Mar 2014 (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.
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Detailed description
Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: VaccineVaccine Flubio (Influenza HA) vaccine 2 doses for infants and children (6 months - 8 years old) 1 doses for children (9-11 years old) The vaccine will be given intramuscularly |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy
- Parents have been informed properly regarding the study and signed the informed consent form
- Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial
Key exclusion criteria (8 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature >=37oC)
- Known history of allergy to egg and/or chicken protein or any other component of the vaccines
- Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (>2 weeks)).
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 |
|---|---|---|
| VaccineAlso: FlubioFlubio (Influenza HA) Vaccine The vaccine will be given intramuscularly. | Biological | Vaccine |
Primary outcome
To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)
Time frame: 2 months
Percentage of subjects with anti HI titer >=1:40
3 secondary outcomes
To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)
Time frame: 2 months
To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)
Time frame: 1 months
To asses the safety of Flubio vaccine
Time frame: 1-2 months
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 29 Apr 2015.
- Derived from this study: PubMed 29551225Soedjatmiko S, Medise BE, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Bachtiar NS, Sari RM. Immunogenicity and safety of a Trivalent Influenza HA vaccine in Indonesian infants and children. Vaccine. 2018 Apr 12;36(16):2126-2132. doi: 10.1016/j.vaccine.2018.02.114. Epub 2018 Mar 16.
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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.
Bernie Endyarni, MD principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vaccine in people with Healthy, run by PT Bio Farma at 2 sites 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 3 inclusion and 8 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02093260, which also lists 1 linked publication.
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 29 Apr 2015.