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InfluenzaPhase 3NCT00630331

Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

A Phase 3 study testing Cell culture-derived influenza vaccine and Egg-derived influenza virus vaccine in people with Influenza, run by Novartis Vaccines at 56 sites in 3 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

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Cell culture-derived influenza vaccine and Egg-derived influenza virus vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11,404 participants
Where
56 sitesin 3 countries
Study dates
Oct 2007to Jul 2008
Phase
Phase 3
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 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • subjects 18 to 49 years of age;
  • in good health as determined by medical history and physical examination;
  • able and willing to provide written informed consent prior to any study procedure;
  • able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Who cannot join

  • history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
  • any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
  • employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person;
  • history of Guillain-Barré syndrome;
  • bleeding diathesis;
  • receipt of another investigational agent within 90 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
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  • receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
  • laboratory-confirmed influenza disease within 6 months prior to Visit 1;
  • receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study;
  • experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days prior to study vaccination;
  • pregnant or breast-feeding female;
  • if female of childbearing potential and sexually active, has not used any of the birth control methods detailed in the section entitled "Females of Childbearing Potential" for at least 2 months prior to study entry;
  • if female of childbearing potential and sexually active, refusal to use a reliable contraceptive method as detailed in the section entitled "Females of Childbearing Potential" during the first 3 weeks after 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.;
  • any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or with the safety of the study subject.

Trial locations and contacts

56 sites in 3 countries.

56 sites in 3 countries

Poland24 sites

  • Site 49

    Bydgoszcz, 85-316

  • Site 62

    Gmina Końskie, 26-200

  • Site 53

    Gniewkowo, 88-140

  • Site 59

    Katowice, 40-084

  • Site 63

    Kielce, 25-711

  • Site 57

    Krakow, 30-510

  • Site 41

    Krakow, 30-969

  • Site 43

    Krakow, 31-115

  • Site 42

    Krakow, 31-503

  • Site 50

    Krakow, 31-832

  • Site 51

    Łodź, 90-302

  • Site 44

    Lubartów, 21 - 100

  • Site 45

    Lublin, 20-044

  • Site 65

    Oleśnica, 56-400

  • Site 47

    Olsztyn, 10-117

  • Site 48

    Olsztyn, 10-295

  • Site 46

    Olsztyn, 10-461

  • Site 58

    Radziszów, 32-052

  • Site 61

    Ruda Śląska, 41-703

  • Site 60

    Rzeszów, 35-324

  • Site 54

    Wąbrzeźno, 87-200

  • Site 52

    Warsaw, 02-777

  • Site 55

    Wilkowice, 43-365

  • Site 64

    Wroclaw, 51-312

Other trials in Poland

United States17 sites

  • Site 12

    Anderson, South Carolina, 29621

  • Site 9

    Austin, Texas, 78705

  • Site 2

    Bardstown, Kentucky, 40004

  • Site 10

    Binghamton, New York, 13901

  • Site 6

    Burke, Virginia, 22105

  • Site 8

    Dallas, Texas, 75234

  • Site 14

    Denver, Colorado, 80212

  • Site 4

    Edison, New Jersey, 08817

  • Site 5

    Endwell, New York, 13760

  • Site 13

    Lenexa, Kansas, 66219

  • Site 15

    Pembroke Pines, Florida, 33024

  • Site 7

    Salt Lake City, Utah, 84109

  • Site 3

    Salt Lake City, Utah, 84121

  • Site 17

    South Miami, Florida, 33143

  • Site 1

    St Louis, Missouri, 63140

  • Site 11

    Warwick, Rhode Island, 02886

  • Site 16

    Winston-Salem, North Carolina, 27103

Other trials in United States

Finland15 sites

  • Site 25

    Espoo, 02100

  • Site 26

    Helsinki, 00100

  • Site 27

    Helsinki, 00930

  • Site 33

    Jarvenpaa, 04400

  • Site 35

    Kokkola, 67100

  • Site 34

    Kotka, 48600

  • Site 30

    Kuopio, 70100

  • Site 22

    Lahti, 15140

  • Site 31

    Oulu, 90100

  • Site 23

    Pori, 28120

  • Site 32

    Seinäjoki, 60100

  • Site 21

    Tampere, 33100

  • Site 24

    Turku, 20520

  • Site 28

    Vantaa, 01300

  • Site 29

    Vantaa, 01600

Other trials in Finland

About this study

Official title: A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Assess Clinical Efficacy of a Cell-Derived Subunit Influenza Vaccine and an Egg-Derived Subunit Influenza Vaccine in the 2007-2008 Influenza Season in Healthy Adult Subjects

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Conditions
Influenza
Being tested
Cell culture-derived influenza vaccine, Egg-derived influenza virus vaccine, Placebo
Keywords
Influenza, Flu, Cell Culture-Derived, Egg-Derived, Healthy Adults, Efficacy, Safety, Immunogenicity, Trivalent, Inactivated, Influenza-Like Illness, Vaccination
Medical subject headings
Influenza, Human

What participants receive

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

  • Cell culture-derived influenza vaccineBiological

    One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.

  • Egg-derived influenza virus vaccineBiological

    One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.

  • PlaceboBiological

    One dose (0.5 mL) of phosphate buffered solution.

Study groups in NCT00630331
Study groupRoleWhat they receive
CCIExperimentalSubjects received one dose of cell culture-derived influenza vaccine.
Receives: Biological: Cell culture-derived influenza vaccine
IVVExperimentalSubjects received one dose of the trivalent egg-derived influenza vaccine.
Receives: Biological: Egg-derived influenza virus vaccine
PlaceboPlacebo comparatorSubjects received one dose of phosphate buffered solution (PBS).
Receives: Biological: Placebo

What is being measured

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

  1. Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains

    The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.

    Measured: 6 Months

Secondary outcomes (11)

  1. Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains

    The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.

    Measured: 6 Months

  2. Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains

    The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.

    Measured: 6 Months

  3. Influenza-Associated Days in Bed, All Subjects

    The number of subjects in this analysis included all subjects in the per protocol efficacy population.

    Measured: 6 Months

  4. Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza

    The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

    Measured: 6 Months

  5. Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects

    The number of subjects in this analysis included all subjects in the per protocol efficacy population.

    Measured: 6 Months

  6. Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza

    The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

    Measured: 6 Months

  7. Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects

    The number of subjects in this analysis included all subjects in the per protocol efficacy population.

    Measured: 6 Months

  8. Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza

    The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

    Measured: 6 Months

  9. Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo

    Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.

    Measured: Before vaccination (day 1) and three weeks after vaccination (day 22)

  10. Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo

    As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.

    Measured: Three weeks after vaccination (day 22)

  11. Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination

    The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.

    Measured: Up to 7 days post vaccination

Timeline

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

  1. First posted7 Mar 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2008
  4. Study completionJul 2008

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
11,404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00630331
Sponsor's protocol ID
V58P13
Other IDs
2007-002871-15, 11580
Status last verified
May 2024
First submitted
28 Feb 2008
Last updated
24 May 2024

Publications

  • Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S. Clinical efficacy of cell culture-derived and egg-derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis. 2010 Nov 1;51(9):997-1004. doi: 10.1086/656578.

    PubMed 20868284

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cell culture-derived influenza vaccine and Egg-derived influenza virus vaccine in people with Influenza, run by Novartis Vaccines at 56 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 4 inclusion and 15 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 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Poland, United States, Finland. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Jan 2013). 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?

Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains (time frame: 6 Months). 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 NCT00630331, 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 24 May 2024.

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