InfluenzaPhase 1NCT00848848
Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older
A Phase 1 study testing Trivalent Influenza Vaccine, Trivalent Influenza Vaccine + high A and Trivalent Influenza Vaccine + ¼ dose adjuvant in people with Influenza, run by Seqirus at 1 site in Belgium.
Trial summary
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent Influenza Vaccine, Trivalent Influenza Vaccine + high A and Trivalent Influenza Vaccine + ¼ dose adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Apr 2009
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.
Who cannot join
- Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
- Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
- Conditions
- Influenza
- Being tested
- Trivalent Influenza Vaccine, Trivalent Influenza Vaccine + high A, Trivalent Influenza Vaccine + ¼ dose adjuvant, Trivalent Influenza Vaccine + high A + ¼ dose adjuvant, Trivalent Influenza Vaccine + ½ dose adjuvant
- Keywords
- Influenza, Flu, Vaccine, Intradermal, Adjuvant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Influenza VaccineBiological
1 dose of Trivalent Influenza Vaccine
Trivalent Influenza Vaccine + high ABiological
1 dose of Trivalent Influenza Vaccine with high A content
Trivalent Influenza Vaccine + ¼ dose adjuvantBiological
1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
Trivalent Influenza Vaccine + high A + ¼ dose adjuvantBiological
1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
Trivalent Influenza Vaccine + ½ dose adjuvantBiological
1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
Trivalent Influenza Vaccine + high A + ½ dose adjuvantBiological
1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
Trivalent Influenza Vaccine + adjuvantBiological
1 dose of Trivalent Influenza Vaccine plus adjuvant
Trivalent Influenza Vaccine + high A + adjuvantBiological
1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
Trivalent Influenza Vaccine intradermal doseBiological
1 dose of Trivalent Influenza Vaccine intradermal dose
Trivalent Influenza Vaccine + high A intradermal doseBiological
1 intradermal dose of Trivalent Influenza Vaccine + high A
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine |
| 2 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + high A |
| 3 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant |
| 4 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant |
| 5 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + ½ dose adjuvant |
| 6 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant |
| 7 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + adjuvant |
| 8 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + high A + adjuvant |
| 9 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine intradermal dose |
| 10 | Active comparator | Not described Receives: Biological: Trivalent Influenza Vaccine + high A intradermal dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Measured: 21 days
Secondary outcomes (1)
Strain-specific influenza antibody titers will be used to assess Immunogenicity
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848848
- Sponsor's protocol ID
- V104P3
- Other IDs
- 2008-002625-36, 2008
- Status last verified
- May 2016
- First submitted
- 19 Feb 2009
- Last updated
- 9 May 2016
- Results posted
- No
Publications
Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli C, Groth N, Levin Y, Del Giudice G. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59(R)-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10. doi: 10.4161/hv.28618. Epub 2014 Apr 14.
PubMed 24732325Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1.
PubMed 22426371
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years
- ClinicalTrials.gov ID
- NCT00848848
- Acronym / sponsor ID
- V104P3
- Conditions
- Influenza
- Keywords
- Influenza, Flu, Vaccine, Intradermal, Adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Feb 2009 (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 study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Trivalent Influenza Vaccine |
| 2 | Active comparator | Biological: Trivalent Influenza Vaccine + high A |
| 3 | Active comparator | Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant |
| 4 | Active comparator | Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant |
| 5 | Active comparator | Biological: Trivalent Influenza Vaccine + ½ dose adjuvant |
| 6 | Active comparator | Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant |
| 7 | Active comparator | Biological: Trivalent Influenza Vaccine + adjuvant |
| 8 | Active comparator | Biological: Trivalent Influenza Vaccine + high A + adjuvant |
| 9 | Active comparator | Biological: Trivalent Influenza Vaccine intradermal dose |
| 10 | Active comparator | Biological: Trivalent Influenza Vaccine + high A intradermal dose |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.
Key exclusion criteria (2 listed)
- Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
- Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.
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 |
|---|---|---|
| Trivalent Influenza Vaccine1 dose of Trivalent Influenza Vaccine | Biological | 1 |
| Trivalent Influenza Vaccine + high A1 dose of Trivalent Influenza Vaccine with high A content | Biological | 2 |
| Trivalent Influenza Vaccine + ¼ dose adjuvant1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant | Biological | 3 |
| Trivalent Influenza Vaccine + high A + ¼ dose adjuvant1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant | Biological | 4 |
| Trivalent Influenza Vaccine + ½ dose adjuvant1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant | Biological | 5 |
| Trivalent Influenza Vaccine + high A + ½ dose adjuvant1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant | Biological | 6 |
| Trivalent Influenza Vaccine + adjuvant1 dose of Trivalent Influenza Vaccine plus adjuvant | Biological | 7 |
| Trivalent Influenza Vaccine + high A + adjuvant1 dose of Trivalent Influenza Vaccine with high A plus adjuvant | Biological | 8 |
| Trivalent Influenza Vaccine intradermal dose1 dose of Trivalent Influenza Vaccine intradermal dose | Biological | 9 |
| Trivalent Influenza Vaccine + high A intradermal dose1 intradermal dose of Trivalent Influenza Vaccine + high A | Biological | 10 |
Primary outcome
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Time frame: 21 days
1 secondary outcome
Strain-specific influenza antibody titers will be used to assess Immunogenicity
Time frame: 21 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 9 May 2016.
- Derived from this study: PubMed 24732325Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli C, Groth N, Levin Y, Del Giudice G. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59(R)-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10. doi: 10.4161/hv.28618. Epub 2014 Apr 14.
- Derived from this study: PubMed 22426371Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1.
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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.
Novartis Vaccines study chair
Novartis Vaccines
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 Trivalent Influenza Vaccine, Trivalent Influenza Vaccine + high A and Trivalent Influenza Vaccine + ¼ dose adjuvant in people with Influenza, run by Seqirus at 1 site in Belgium.
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 2 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 9 May 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 Belgium. 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?
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. (time frame: 21 days). 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 NCT00848848, which also lists 2 linked publications.
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 9 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.