InfluenzaPhase 2NCT00479648
A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants
A Phase 2 study testing CSL412 and Inactivated trivalent influenza vaccine in people with Influenza, run by Seqirus at 1 site in United Kingdom.
Trial summary
Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CSL412 and Inactivated trivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to Aug 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 to ≤ 45 OR ≥ 60
- Ability to provide pre-vaccination venous blood sample
Who cannot join
- History of clinically significant medical conditions
- Immunomodulative therapy
- Acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)
Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.
- Conditions
- Influenza
- Being tested
- CSL412, Inactivated trivalent influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL412Biological
Inactivated trivalent influenza vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Inactivated trivalent influenza vaccine Receives: Biological: Inactivated trivalent influenza vaccine |
| 2 | Experimental | CSL412 formulation Receives: Biological: CSL412 |
| 3 | Experimental | CSL412 formulation Receives: Biological: CSL412 |
| 4 | Experimental | CSL412 formulation Receives: Biological: CSL412 |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprotection rate, HI titre & seroconversion/ significant increase
grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elizabeth Hancox, Dr, Principal investigator, Chiltern International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479648
- Sponsor's protocol ID
- CSLCT-IIV-06-27
- Status last verified
- Nov 2008
- First submitted
- 25 May 2007
- Last updated
- 19 Jul 2016
- Results posted
- No
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 Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)
- ClinicalTrials.gov ID
- NCT00479648
- Acronym / sponsor ID
- CSLCT-IIV-06-27
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 28 May 2007 (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.
Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Inactivated trivalent influenza vaccineInactivated trivalent influenza vaccine |
| 2 | Experimental | Biological: CSL412CSL412 formulation |
| 3 | Experimental | Biological: CSL412CSL412 formulation |
| 4 | Experimental | Biological: CSL412CSL412 formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 18 to ≤ 45 OR ≥ 60
- Ability to provide pre-vaccination venous blood sample
Key exclusion criteria (3 listed)
- History of clinically significant medical conditions
- Immunomodulative therapy
- Acute infection
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 |
|---|---|---|
| CSL412 | Biological | 2, 3, 4 |
| Inactivated trivalent influenza vaccine | Biological | 1 |
Primary outcome
seroprotection rate, HI titre & seroconversion/ significant increase
grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis
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.
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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.
Elizabeth Hancox, Dr principal investigator
Chiltern International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSL412 and Inactivated trivalent influenza vaccine in people with Influenza, run by Seqirus at 1 site in United Kingdom.
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 2 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 1 site in United Kingdom. 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?
seroprotection rate, HI titre & seroconversion/ significant increase. The study lists 2 primary outcomes in all. 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 19 Jul 2016.