InfluenzaPhase 2NCT00320346
Phase II Study of Pandemic Influenza Vaccine
A Phase 2 study testing Pandemic Influenza Vaccine in people with Influenza, run by Seqirus at 3 sites in Australia.
Trial summary
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Pandemic Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 3 sitesAustralia
- Study dates
- Jul 2006to Sep 2006
- Phase
- Phase 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adults
Who cannot join
- Previous vaccination with an influenza Vaccine containing the H5N1 strain
- History of clinically significant medical conditions
- History of Guillian-Barre Syndrome or active Neurological disease
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
CMAX, a division of IDT Australia
Adelaide, South Australia
Murdoch Childrens Research Institute
Melbourne, Victoria, 3052
Princess Margaret Hospital for Children
Perth, Western Australia
About this study
Official title: A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.
- Conditions
- Influenza
- Being tested
- Pandemic Influenza Vaccine
- Keywords
- Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic Influenza VaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Immunogenicity
Secondary outcomes (1)
Lot to Lot Consistency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJul 2006
- Study completionSep 2006
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 InfluenzaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Richmond, Dr, Principal investigator, Princess Margaret Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320346
- Sponsor's protocol ID
- CSLCT-PAN-05-18
- Status last verified
- Nov 2008
- First submitted
- 1 May 2006
- Last updated
- 19 Jul 2016
- Results posted
- No
Publications
Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.
PubMed 18599164
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Multi-Centre Study to Evaluate the Safety, Tolerability, Immunogenicity and Lot to Lot Consistency of Two Formulations of CSL Limited's Inactivated Prototype Pandemic Influenza Vaccine in a Healthy Adult Population (≤18 Years to ≥64 Years of Age).
- ClinicalTrials.gov ID
- NCT00320346
- Acronym / sponsor ID
- CSLCT-PAN-05-18
- Conditions
- Influenza
- Keywords
- Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 3 May 2006 (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 World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Adults
Key exclusion criteria (3 listed)
- Previous vaccination with an influenza Vaccine containing the H5N1 strain
- History of clinically significant medical conditions
- History of Guillian-Barre Syndrome or active Neurological disease
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 |
|---|---|---|
| Pandemic Influenza Vaccine | Biological | – |
Primary outcome
Safety and Immunogenicity
1 secondary outcome
Lot to Lot Consistency
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 19 Jul 2016.
- Derived from this study: PubMed 18599164Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.
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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.
Peter Richmond, Dr principal investigator
Princess Margaret Hospital for Children
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pandemic Influenza Vaccine in people with Influenza, run by Seqirus at 3 sites in Australia.
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 1 inclusion and 3 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 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?
Safety and Immunogenicity. 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 NCT00320346, 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 19 Jul 2016.