Seasonal InfluenzaPhase 2NCT01152814

Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011

A Phase 2 study testing Seasonal flu vaccine in people with Seasonal Influenza, run by Novartis Vaccines at 6 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to 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: Seasonal Influenza
What is being tested?: Seasonal flu vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 6 sitesItaly
Study dates: Jun 2010to Jul 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males and females volunteers of 65 years of age or older
Mentally competent
Willing and able to give written informed consent prior to study entry.
Able to comply with all the study requirements.
In general good health

Who cannot join

Any serious chronic or acute disease
History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
Known or suspected impairment/alteration of immune function
Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination
Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Italy6 sites

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, 66100
Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
Ferrara, 44100
Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
Genova, 16132
Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
Lanciano, 66034
Centro Satellite. Distretto Sanitario di Base di Fossacesia in Via Polidoro-Vasto
Lanciano
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20
Milan, 20127

Other trials in Italy

About this study

Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2010-2011, When Administered to Elderly Subjects

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects

Conditions: Seasonal Influenza
Being tested: Seasonal flu vaccine
Keywords: Seasonal influenza, Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Seasonal flu vaccineBiological
This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)

Study groups in NCT01152814
Study group	Role	What they receive
Arm 1	Experimental	No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit Receives: Biological: Seasonal flu vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD
Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.
The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).
Measured: day 22
Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years).
Measured: day 22
Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).
This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).
Measured: day 22

Secondary outcomes (1)

Number of Participants Who Reported Solicited Local and Systemic Reactions
Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.
Measured: 1 to 4 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Jul 2010

First posted29 Jun 2010 (estimated)
Study startJun 2010
Primary completionJun 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Seasonal 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152814
Sponsor's protocol ID: V70_25S
Other IDs: 2010-018603-29
Status last verified: Dec 2015
First submitted: 28 Jun 2010
Last updated: 27 Jan 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Seasonal Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2010-2011, When Administered to Elderly Subjects
ClinicalTrials.gov ID: NCT01152814
Acronym / sponsor ID: V70_25S
Conditions: Seasonal Influenza
Keywords: Seasonal influenza, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jun 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Posted 27 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Biological: Seasonal flu vaccineNo comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Males and females volunteers of 65 years of age or older
Mentally competent
Willing and able to give written informed consent prior to study entry.
Able to comply with all the study requirements.
In general good health

Key exclusion criteria (7 listed)

Any serious chronic or acute disease
History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
Known or suspected impairment/alteration of immune function
Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine

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
Seasonal flu vaccineThis phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)	Biological	Arm 1

Primary outcome

Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD
Time frame: day 22
Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase. The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).
Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Time frame: day 22
Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years).
Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Time frame: day 22
Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22). This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).

1 secondary outcome

Number of Participants Who Reported Solicited Local and Systemic Reactions
Time frame: 1 to 4 days post-vaccination

Results and safety

Results posted to the registry on 27 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLUAD	64	62

Primary outcome: Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD

Time frame: day 22. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	FLUAD n = 62
A/H1N1	45 (32 to 58)
A/H3N2	61 (48 to 73)
B	27 (17 to 40)

Population analysed: Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation.

Primary outcome: Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD

Time frame: day 22. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	FLUAD n = 62
A/H1N1	1.96 (1.59 to 2.42)
A/H3N2	1.88 (1.64 to 2.16)
B	1.32 (1.22 to 1.43)

Population analysed: Analysis was done using the PP dataset.

Primary outcome: Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD

Time frame: day 22. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	FLUAD n = 62
A/H1N1	97 (89 to 100)
A/H3N2	71 (58 to 82)
B	100 (94 to 100)

Population analysed: Analysis was done using the PP dataset.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From Day 1 through Day 22.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLUAD	0 of 64 (0%)	4 of 64 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Seasonal Influenza

RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
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Not yet recruitingPhase 1
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Not yet recruitingPhase 4
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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.

The record lists no contact. Use the official record to reach the sponsor.

6 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 Seasonal flu vaccine in people with Seasonal Influenza, run by Novartis Vaccines at 6 sites in Italy.

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 5 inclusion and 7 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD (time frame: day 22). 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?

On the ClinicalTrials.gov record for NCT01152814.

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 Jan 2016.