HealthyPhase 1/2NCT01666262
Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
A Phase 1/2 study testing Vaccine A/17/CA/2009/38 (H1N1) in people with Healthy, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays. Read more about this study
- Who is it for?
- Ages 9 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vaccine A/17/CA/2009/38 (H1N1)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2009to Jan 2012
- Phase
- Phase 1/2
- 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 9 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy
- Age 9 - >49 years old
- Having Thai ID card or equivalent
- Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
- Anti HIV - Negative
- All hematology \& biochemistry within normal range
- Able to read and write and sign written informed consent
Who cannot join
- Known history of egg allergy
- Having had recently influenza infection confirmed as H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
- History of bronchial asthma
- History of chronic lung diseases
- History of chronic rhinitis
- History of immunodeficiency state
Show all 14Show fewer
- History of immunosuppression
- Acute infectious and noninfectious diseases (within 2 weeks)
- Exacerbation of chronic diseases or cancer or HIV positives
- Anamnestic leukocytosis, hepatitis B and C positives
- The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
- Participation in other research study
- Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
- Any concomitant medication with Aspirin
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.
Read the detailed description
Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.
Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
- Conditions
- Healthy
- Being tested
- Vaccine A/17/CA/2009/38 (H1N1), Placebo:Stabilizer
- Keywords
- FLU, H1N1, GPO, PLAIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine A/17/CA/2009/38 (H1N1)Biological
Also called GPO Flu Vaccine-01
Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
Placebo:StabilizerOther
5% sucrose
| Study group | Role | What they receive |
|---|---|---|
| A/17/CA/2009/38 (H1N1) | Experimental | Not described Receives: Biological: Vaccine A/17/CA/2009/38 (H1N1) |
| Stabilizer | Placebo comparator | Not described Receives: Other: Placebo:Stabilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic reaction and local reaction (vital sign, temperature)
Measured: 11/2 year
Secondary outcomes (1)
Humoral immune response
Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA.
Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine.
Measured: 11/2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startSep 2009
- Study completionJan 2012
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punnee Pitisuttithum, Mahidol University
- Investigators
- Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666262
- Sponsor's protocol ID
- GPO FLU VACCINE-01
- Status last verified
- Aug 2012
- First submitted
- 11 Jan 2010
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
- ClinicalTrials.gov ID
- NCT01666262
- Acronym / sponsor ID
- GPO FLU VACCINE-01
- Conditions
- Healthy
- Keywords
- FLU, H1N1, GPO, PLAIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Aug 2012 (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 purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.
Detailed description
Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.
Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A/17/CA/2009/38 (H1N1) | Experimental | Biological: Vaccine A/17/CA/2009/38 (H1N1) |
| Stabilizer | Placebo comparator | Other: Placebo:Stabilizer |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy
- Age 9 - >49 years old
- Having Thai ID card or equivalent
- Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
- Anti HIV - Negative
Key exclusion criteria (14 listed)
- Known history of egg allergy
- Having had recently influenza infection confirmed as H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
- History of bronchial asthma
- History of chronic lung diseases
- History of chronic rhinitis
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 |
|---|---|---|
| Vaccine A/17/CA/2009/38 (H1N1)Also: GPO Flu Vaccine-01Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) | Biological | A/17/CA/2009/38 (H1N1) |
| Placebo:Stabilizer5% sucrose | Other | Stabilizer |
Primary outcome
Systemic reaction and local reaction (vital sign, temperature)
Time frame: 11/2 year
1 secondary outcome
Humoral immune response
Time frame: 11/2 year
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 16 Aug 2012.
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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.
Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaccine A/17/CA/2009/38 (H1N1) in people with Healthy, run by Mahidol University at 1 site in Thailand.
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 7 inclusion and 14 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 16 Aug 2012. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Systemic reaction and local reaction (vital sign, temperature) (time frame: 11/2 year). 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 16 Aug 2012.