Human InfluenzaPhase 2NCT01636102

Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

A Phase 2 study testing Trivalent influenza virus vaccine (TIV) in people with Human Influenza, run by Novartis Vaccines at 1 site in Belgium.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Human Influenza
What is being tested?: Trivalent influenza virus vaccine (TIV)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteBelgium
Study dates: Jul 2012to Jul 2012
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female volunteers of 18 years of age or older;
Individuals able to comply with all the study requirements;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator

Who cannot join

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could have interfered with the subject's ability to participate in the study.
Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment);
Medically significant advanced congestive heart failure (ie. NYHA class III and IV);
Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV);
Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥5 years);

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Diabetes mellitus type I;
Poorly controlled diabetes mellitus type II;
Advanced arteriosclerotic disease;
History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);
Acute or progressive hepatic disease;
Acute or progressive renal disease;
Severe neurological (es. Guillain-Barré syndrome) or psychiatric disorder;
Severe asthma.
Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).
Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
receipt of immunostimulants;
receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
suspected or known HIV infection or HIV-related disease.
Individuals with known or suspected history of drug or alcohol abuse.
Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion could have interfered with the safety of the subject.
Individuals who were not able to comprehend and to follow all required study procedures for the whole period of the study.
Individuals with history or any illness that, in the opinion of the investigator, posed additional risk to the subjects due to participation in the study.
Individuals who within the past 6 months have:
had any laboratory confirmed seasonal or pandemic influenza disease;
received any seasonal or pandemic influenza vaccine.
Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who were planning to receive any vaccine during the study.
Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
Individuals who experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
Individuals who were part of study personnel or close family members conducting this study.
BMI >35 kg/m2.
Females who were pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding). Females of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospital Ghent, Center for Vaccinology, Prof.Dr. G Leroux Roels
Ghent, Ghent, BC001

Other trials in Belgium

About this study

Official title: A Phase II Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Agrippal®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects

To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions: Human Influenza
Being tested: Trivalent influenza virus vaccine (TIV)
Keywords: Influenza, Adults, Elderly, Immunology, Safety
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 virus vaccine (TIV)Biological
A single 0.5 mL dose of the study vaccine supplied in prefilled syringes and administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Study groups in NCT01636102
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Biological: Trivalent influenza virus vaccine (TIV)

What is being measured

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

Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.
Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years).
Measured: Day 22
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).
The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years).
Measured: Day 22
Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV
Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22).
This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years).
Measured: Day 1 and 22

Secondary outcomes (1)

Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIV vaccination.
Measured: From day 1 through day 4 postvaccination

Timeline

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

Jul 2012Jul 2012

First posted10 Jul 2012 (estimated)
Study startJul 2012
Primary completionJul 2012
Study completionJul 2012

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 Human 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: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01636102
Sponsor's protocol ID: V71_32S
Other IDs: 2012-000063-24
Status last verified: Nov 2015
First submitted: 5 Jul 2012
Last updated: 30 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Agrippal®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects
ClinicalTrials.gov ID: NCT01636102
Acronym / sponsor ID: V71_32S
Conditions: Human Influenza
Keywords: Influenza, Adults, Elderly, Immunology, Safety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 10 Jul 2012 (estimated)
Results: Posted 29 Jan 2014

Clinical summary

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

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: Trivalent influenza virus vaccine (TIV)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and female volunteers of 18 years of age or older;
Individuals able to comply with all the study requirements;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator

Key exclusion criteria (34 listed)

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could have interfered with the subject's ability to participate in the study.
Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).
Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
Individuals with known or suspected history of drug or alcohol abuse.

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 virus vaccine (TIV)A single 0.5 mL dose of the study vaccine supplied in prefilled syringes and administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm	Biological	Arm 1

Primary outcome

Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV
Time frame: Day 22
Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years).
Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV
Time frame: Day 22
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years).
Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV
Time frame: Day 1 and 22
Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years).

1 secondary outcome

Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)
Time frame: From day 1 through day 4 postvaccination

Results and safety

Results posted to the registry on 29 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
18-60 Y	63	63
≥61 Y	63	63

Primary outcome: Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV

Time frame: Day 22. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	18-60 Y n = 62	≥61 Y n = 62
A/H1N1	84 (72 to 92)	53 (40 to 66)
A/H3N2	81 (69 to 90)	65 (51 to 76)
B	69 (56 to 80)	73 (60 to 83)

Population analysed: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Primary outcome: Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV

Time frame: Day 22. Number (95% Confidence Interval). Unit: Ratio

Measure	18-60 Y n = 62	≥61 Y n = 62
A/H1N1	5.7 (4.3 to 7.55)	2.88 (2.26 to 3.65)
A/H3N2	5.52 (4.16 to 7.31)	3.02 (2.35 to 3.86)
B	3.72 (2.69 to 5.15)	4.06 (3.12 to 5.28)

Population analysed: Analysis was done on the PP set.

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

Time frame: Day 1 and 22. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	18 - 60 Y n = 62	≥61 Y n = 62
A/H1N1 (Day 1)	34 (22 to 47)	27 (17 to 40)
A/H1N1 (Day 22)	95 (87 to 99)	71 (58 to 82)
A/H3N2 (Day 1)	23 (13 to 35)	45 (32 to 58)
A/H3N2 (Day 22)	85 (74 to 93)	92 (82 to 97)
B (Day 1)	61 (48 to 73)	21 (12 to 33)
B (Day 22)	97 (89 to 100)	82 (70 to 91)

Population analysed: Analysis was done on the PP set.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From day 1 through day 22.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18-60 Y	0 of 63 (0%)	28 of 63 (44.4%)	Not reported
≥61 Y	0 of 63 (0%)	18 of 63 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 and Diagnostics 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 2 study testing Trivalent influenza virus vaccine (TIV) in people with Human Influenza, run by Novartis Vaccines 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 3 inclusion and 34 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 30 Nov 2015. 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 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 29 Jan 2014). 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 Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV (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 NCT01636102.

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 30 Nov 2015.