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

May 22, 2024 updated by: Novartis Vaccines

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02100
        • Site 25
      • Helsinki, Finland, 00100
        • Site 26
      • Helsinki, Finland, 00930
        • Site 27
      • Järvenpää, Finland, 04400
        • Site 33
      • Kokkola, Finland, 67100
        • Site 35
      • Kotka, Finland, 48600
        • Site 34
      • Kuopio, Finland, 70100
        • Site 30
      • Lahti, Finland, 15140
        • Site 22
      • Oulu, Finland, 90100
        • Site 31
      • Pori, Finland, 28120
        • Site 23
      • Seinäjoki, Finland, 60100
        • Site 32
      • Tampere, Finland, 33100
        • Site 21
      • Turku, Finland, 20520
        • Site 24
      • Vantaa, Finland, 01300
        • Site 28
      • Vantaa, Finland, 01600
        • Site 29
  • Poland
      • Bydgoszcz, Poland, 85-316
        • Site 49
      • Gniewkowo, Poland, 88-140
        • Site 53
      • Katowice, Poland, 40-084
        • Site 59
      • Kielce, Poland, 25-711
        • Site 63
      • Końskie, Poland, 26-200
        • Site 62
      • Krakow, Poland, 30-510
        • Site 57
      • Kraków, Poland, 30-969
        • Site 41
      • Kraków, Poland, 31-115
        • Site 43
      • Kraków, Poland, 31-503
        • Site 42
      • Kraków, Poland, 31-832
        • Site 50
      • Lubartów, Poland, 21 - 100
        • Site 44
      • Lublin, Poland, 20-044
        • Site 45
      • Oleśnica, Poland, 56-400
        • Site 65
      • Olsztyn, Poland, 10-117
        • Site 47
      • Olsztyn, Poland, 10-295
        • Site 48
      • Olsztyn, Poland, 10-461
        • Site 46
      • Radziszów, Poland, 32-052
        • Site 58
      • Ruda Śląska, Poland, 41-703
        • Site 61
      • Rzeszów, Poland, 35-324
        • Site 60
      • Warszawa, Poland, 02-777
        • Site 52
      • Wilkowice, Poland, 43-365
        • Site 55
      • Wrocław, Poland, 51-312
        • Site 64
      • Wąbrzeźno, Poland, 87-200
        • Site 54
      • Łodź, Poland, 90-302
        • Site 51
  • United States
    • Colorado
      • Denver, Colorado, United States, 80212
        • Site 14
    • Florida
      • Pembroke Pines, Florida, United States, 33024
        • Site 15
      • South Miami, Florida, United States, 33143
        • Site 17
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Site 13
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Site 2
    • Missouri
      • Saint Louis, Missouri, United States, 63140
        • Site 1
    • New Jersey
      • Edison, New Jersey, United States, 08817
        • Site 4
    • New York
      • Binghamton, New York, United States, 13901
        • Site 10
      • Endwell, New York, United States, 13760
        • Site 5
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Site 16
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Site 11
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Site 12
    • Texas
      • Austin, Texas, United States, 78705
        • Site 9
      • Dallas, Texas, United States, 75234
        • Site 8
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Site 7
      • Salt Lake City, Utah, United States, 84121
        • Site 3
    • Virginia
      • Burke, Virginia, United States, 22105
        • Site 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. subjects 18 to 49 years of age;
  2. in good health as determined by medical history and physical examination;
  3. able and willing to provide written informed consent prior to any study procedure;
  4. 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.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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;
  4. history of Guillain-Barré syndrome;
  5. bleeding diathesis;
  6. 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;
  7. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
  8. laboratory-confirmed influenza disease within 6 months prior to Visit 1;
  9. receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study;
  10. experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days prior to study vaccination;
  11. pregnant or breast-feeding female;
  12. 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;
  13. 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;
  14. 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.;
  15. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CCI
Subjects received one dose of cell culture-derived influenza vaccine.
Biological: Cell culture-derived influenza vaccine
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
Experimental: IVV
Subjects received one dose of the trivalent egg-derived influenza vaccine.
Biological: Egg-derived influenza virus vaccine
One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
Placebo Comparator: Placebo
Subjects received one dose of phosphate buffered solution (PBS).
Biological: Placebo
One dose (0.5 mL) of phosphate buffered solution.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains
Time Frame: 6 Months
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.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains
Time Frame: 6 Months
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.
6 Months
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains
Time Frame: 6 Months
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.
6 Months
Influenza-Associated Days in Bed, All Subjects
Time Frame: 6 Months
The number of subjects in this analysis included all subjects in the per protocol efficacy population.
6 Months
Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza
Time Frame: 6 Months
The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
6 Months
Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects
Time Frame: 6 Months
The number of subjects in this analysis included all subjects in the per protocol efficacy population.
6 Months
Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza
Time Frame: 6 Months
The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
6 Months
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects
Time Frame: 6 Months
The number of subjects in this analysis included all subjects in the per protocol efficacy population.
6 Months
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza
Time Frame: 6 Months
The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
6 Months
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22)
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%.
Before vaccination (day 1) and three weeks after vaccination (day 22)
Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Time Frame: Three weeks after vaccination (day 22)
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%.
Three weeks after vaccination (day 22)
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Time Frame: Up to 7 days post vaccination
The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.
Up to 7 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Vaccines

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Novartis Vaccines, Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V58P13
  • 11580 (DAIDS ES Registry Number)
  • 2007-002871-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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