Influenza VaccinesPhase 2NCT01013675
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly
A Phase 2 study testing Influenza Vaccine in people with Influenza Vaccines, run by Abbott Biologicals at 12 sites in 3 countries.
Trial summary
A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects. Read more about this study
- Who is it for?
- Ages 61 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Nov 2009to Apr 2011
- 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 61 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women (elderly)
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- Known to be allergic to constituents of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Estonia5 sites
Site Reference ID/Investigator# 45007
Paide, 72713
Site Reference ID/Investigator# 45012
Saku, 75501
Site Reference ID/Investigator# 45009
Tallinn, 10617
Site Reference ID/Investigator# 45010
Tallinn, 10617
Site Reference ID/Investigator# 45013
Tartu, 51014
Lithuania5 sites
Site Reference ID/Investigator# 45017
Kaunas, 47144
Site Reference ID/Investigator# 45015
Kaunas, 48259
Site Reference ID/Investigator# 45016
Kaunas, 49456
Site Reference ID/Investigator# 45018
Kaunas, 50009
Site Reference ID/Investigator# 45019
Klaipėda, 92231
Czechia2 sites
Site Reference ID/Investigator# 45005
Benátky nad Jizerou, 294 71
Site Reference ID/Investigator# 45004
Hradec Králové, 500 03
About this study
Official title: Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects
A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.
Read the detailed description
This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.
- Conditions
- Influenza Vaccines
- Being tested
- Influenza Vaccine
- Keywords
- influenza, active-controlled, Phase 2
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
surface antigen, inactivated, prepared in cell cultures
Influenza VaccineBiological
surface antigen, inactivated, prepared in egg (influvac ®)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose Receives: Biological: Influenza Vaccine |
| 2 | Active comparator | 15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose Receives: Biological: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
Measured: 3 weeks
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
Measured: 6 months
To assess the safety and tolerability of the cell-derived vaccine following revaccination.
Measured: 6 months
Secondary outcomes (2)
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.
Measured: 3 weeks
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Biologicals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Hanka de Voogd, MD, Study director, Abbott Healthcare Products B.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013675
- Sponsor's protocol ID
- S203.2.009
- Other IDs
- 2009-014767-40, 2009
- Status last verified
- Oct 2011
- First submitted
- 13 Nov 2009
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects
- ClinicalTrials.gov ID
- NCT01013675
- Acronym / sponsor ID
- S203.2.009
- Conditions
- Influenza Vaccines
- Keywords
- influenza, active-controlled, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Abbott BiologicalsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 16 Nov 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.
A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.
Detailed description
This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Influenza Vaccine15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose |
| 2 | Active comparator | Biological: Influenza Vaccine15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women (elderly)
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Key exclusion criteria (3 listed)
- Known to be allergic to constituents of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
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 |
|---|---|---|
| Influenza Vaccinesurface antigen, inactivated, prepared in cell cultures | Biological | 1 |
| Influenza Vaccinesurface antigen, inactivated, prepared in egg (influvac ®) | Biological | 2 |
Primary outcome
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.
Time frame: 3 weeks
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.
Time frame: 6 months
To assess the safety and tolerability of the cell-derived vaccine following revaccination.
Time frame: 6 months
2 secondary outcomes
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.
Time frame: 3 weeks
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Time frame: 6 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 27 Oct 2011.
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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.
Hanka de Voogd, MD study director
Abbott Healthcare Products B.V
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza Vaccine in people with Influenza Vaccines, run by Abbott Biologicals at 12 sites in 3 countries.
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 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 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Estonia, Lithuania, Czechia. 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?
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity. (time frame: 3 weeks). The study lists 3 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 27 Oct 2011.