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Pandemic H5N1 InfluenzaPhase 2NCT00914771

Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 Influenza Vaccines Containing 2 Doses of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

A Phase 2 study testing H5N1 pandemic Influenza vaccine 3.75µg and H5N1 pandemic Influenza vaccine 7.5µg in people with Pandemic H5N1 Influenza, run by Novartis Vaccines at 12 sites in 2 countries.

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 aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in non-elderly and elderly adult subjects in order to submit an extension application for a lower dose of Focetria. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pandemic H5N1 Influenza
What is being tested?
H5N1 pandemic Influenza vaccine 3.75µg and H5N1 pandemic Influenza vaccine 7.5µg
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
722 participants
Where
12 sitesin 2 countries
Study dates
Sep 2009to Dec 2009
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

  • Males and females 18 yrs of age and above on the day of enrollment.
  • Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator
  • Documented consent obtained after the nature of the study has been explained according to local regulatory requirements
  • Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study

Who cannot join

  • Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study or who do not consent to the retention of the subject's serum samples after study completion.
  • Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
  • Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
  • Individuals who have had influenza vaccine or documented suspected influenza disease within 6 months prior to Day 1.
  • Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1. "Laboratory-confirmed" includes:
  • Positive serology result
Show all 37Show fewer
  • Positive viral culture
  • Positive rapid antigen test
  • "Suspected" influenza disease includes: subjects with influenza-like illness within the past 6 months with a household/intimate contact with "laboratory-confirmed" influenza disease
  • Individuals experiencing any acute disease or infection requiring systemic antibiotic or antiviral therapy within 6 days before vaccination (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
  • History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), chicken protein.
  • History of any serious disease, such as:
  • 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) b. autoimmune disease (including rheumatoid arthritis) except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years; c. diabetes mellitus type I; d. poorly controlled diabetes mellitus type II; e. diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas, or infections; f. advanced arteriosclerotic disease; g. severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; h. acute or progressive hepatic disease; i. acute or progressive renal disease; j. medically significant congestive heart failure; k. history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome)
  • Known or suspected impairment/alteration of immune function, including:
  • Receipt of immunosuppressive therapy such as oral or systemic corticosteroids, (use of inhaled, intranasal, or topical corticosteroids is allowed) or cancer chemotherapy within 60 days prior to Visit 1
  • receipt of immunostimulants within 60 days prior to Visit 1
  • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
  • HIV infection or HIV-related disease
  • Heritable immunodeficiency
  • Abnormalities of splenic or thymic function
  • Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Day 1 or planned vaccination before Day 43. Seasonal influenza vaccination is allowed 3 weeks after last study vaccination (after the blood sampling for serology on Day 43)
  • Experienced body temperature ≥38.0°C (100.4°F) within 3 days prior to each study vaccination.
  • Use of antipyretic/analgesic medication within 24 hours of each study vaccination
  • Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study
  • Pregnant or breast-feeding female
  • Any positive or indeterminate pregnancy test
  • If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry
  • Of childbearing potential is defined as status post onset of menarche and not surgically sterile
  • Acceptable birth control methods are defined as one or more of the following:
  • Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse iii. Intrauterine device (IUD) iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry
  • If female of childbearing potential, refusal to use an "acceptable contraceptive method" during the study including day 43.
  • If female of childbearing potential, refusal to submit for pregnancy testing prior to study vaccination
  • Research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.
  • Elective surgery or hospitalization planned during the period of study participation.
  • BMI >35Kg/m2 where BMI is for obese and not for high muscle mass
  • Individuals with history of substance or alcohol abuse within the past 2 years that in the opinion of the Investigator might interfere with the safety of the subject or the evaluation of the study objectives.
  • Any condition, which in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Poland6 sites

  • NZOZ Centrum Zdrowia "Blonie"

    Bydgoszcz

  • Prakytka Lekarzy Rodzinnych "Salus"

    Katowice

  • Szpital Internistyczny

    Krakow

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im.

    Krakow

  • Samodyielny Publiczny ZOZ

    Lubartów

  • NZOZ Praktyka Lekarza Rodzinnego "Eskulap"

    Lubin

Other trials in Poland

Turkey (Türkiye)6 sites

  • Gazi Universitesi Tip Fakultesi

    Ankara

  • Hacettepe Universitesi Tip Fakultesi Ic Hastaliklan

    Ankara

  • T.C.S.B. Ankara Numune Egitim ve Arastirma

    Ankara

  • T.C.S.B.Ataturk Egitim ve Arastirma Hastanesi

    Ankara

  • Osmangazi Universitesi Tip Fakutesi

    Eskişehir

  • Enfeksiyon Hastaliklari ve Klinik Mikeoviyloji

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 3.75 µg or 7.5 μg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

This study aims to demonstrate the non-inferiority of two doses of H5N1 influenza antigen in non-elderly and elderly adult subjects in order to submit an extension application for a lower dose of Focetria.

Being tested
H5N1 pandemic Influenza vaccine 3.75µg, H5N1 pandemic Influenza vaccine 7.5µg
Keywords
Pandemic Influenza, H5N1, Adults and Elderly, antigen dose

What participants receive

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

  • H5N1 pandemic Influenza vaccine 3.75µgBiological

    2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen

  • H5N1 pandemic Influenza vaccine 7.5µgBiological

    2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 7.5µg H5N1 antigen

Study groups in NCT00914771
Study groupRoleWhat they receive
H5N1 pandemic Influenza vaccine 3.75µgActive comparatorNot described
Receives: Biological: H5N1 pandemic Influenza vaccine 3.75µg
H5N1 pandemic Influenza vaccine 7.5µgActive comparatorNot described
Receives: Biological: H5N1 pandemic Influenza vaccine 7.5µg

What is being measured

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

  1. Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined.

    Measured: 43 days

  2. Solicited local reactions: ecchymosis, erythema, induration, swelling and pain at injection site.

    Measured: 6 weeks

  3. Solicited systemic reactions: headache, arthralgia, chills, fatigue, malaise, myalgia, nausea, sweating and fever as measured by axillary temperature for Day 1 through 7 and Day 22 to 28 of the study.

    Measured: 6 weeks

Secondary outcomes (5)

  1. Geometric mean titers/area (GMTs/GMAs) on each blood sampling days as determined by HI and SRH, and the applicable geometric mean ratios.

    Measured: 6 weeks

  2. Percentage of subjects achieving seroconversion or significant increase in antibody titer on each post-vaccination blood sampling days, as measured by HI and SRH.

    Measured: 6 weeks

  3. Percentage of subjects achieving an HI titer ≥40/ SRH area ≥25mm² on each blood sampling days.

    Measured: 6 weeks

  4. Immunogenicity, as determined by HI or SRH, will be assessed according to age-appropriate CHMP criteria (CPMP/BWP/214/96).

    Measured: 6 weeks

  5. Immunogenicity according to CBER criteria in terms of hemagglutination inhibition test in non-elderly adult and elderly subjects separately, for all post-vaccination blood sampling days and the immunogenicity according to microneutralization test

    Measured: 6 weeks

Timeline

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

  1. First posted5 Jun 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

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
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
722 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00914771
Sponsor's protocol ID
V87_17
Status last verified
Oct 2015
First submitted
4 Jun 2009
Last updated
12 Oct 2015
Results posted
No

Publications

  • Czajka H, Unal S, Ulusoy S, Usluer G, Strus A, Sennaroglu E, Guzik J, Topeli Iskit A, Dargiewicz A, Musial D, Caylan R, Dziduch J, Eskioglu E, Hasiec B, Cwinarowiczliwa E, Belli R, Abdel-Messih IA, Beygo J, Fragapane E. A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects. J Prev Med Hyg. 2012 Sep;53(3):136-42.

    PubMed 23362618

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing H5N1 pandemic Influenza vaccine 3.75µg and H5N1 pandemic Influenza vaccine 7.5µg in people with Pandemic H5N1 Influenza, run by Novartis Vaccines at 12 sites in 2 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 4 inclusion and 37 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 12 Oct 2015. 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 Poland, Turkey (Türkiye). 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?

Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined. (time frame: 43 days). 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 NCT00914771, which also lists 1 linked publication.

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 12 Oct 2015.

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