Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
- Conditions
- Influenza
- Interventions
- Biological: Egg-derived influenza virus vaccineBiological: Cell culture-derived influenza vaccineBiological: Placebo
- Registration Number
- NCT00630331
- Lead Sponsor
- Novartis Vaccines
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11404
- 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.
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVV Egg-derived influenza virus vaccine Subjects received one dose of the trivalent egg-derived influenza vaccine. CCI Cell culture-derived influenza vaccine Subjects received one dose of cell culture-derived influenza vaccine. Placebo Placebo Subjects received one dose of phosphate buffered solution (PBS).
- Primary Outcome Measures
Name Time Method Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains 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.
- Secondary Outcome Measures
Name Time Method Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza 6 Months The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains 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.
Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza 6 Months The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo 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%.
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains 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.
Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects 6 Months The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Influenza-Associated Days in Bed, All Subjects 6 Months The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects 6 Months The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza 6 Months The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo 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%.
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination 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.
Trial Locations
- Locations (56)
Site 43
🇵🇱Kraków, Poland
Site 22
🇫🇮Lahti, Finland
Site 31
🇫🇮Oulu, Finland
Site 17
🇺🇸South Miami, Florida, United States
Site 5
🇺🇸Endwell, New York, United States
Site 10
🇺🇸Binghamton, New York, United States
Site 1
🇺🇸Saint Louis, Missouri, United States
Site 11
🇺🇸Warwick, Rhode Island, United States
Site 6
🇺🇸Burke, Virginia, United States
Site 26
🇫🇮Helsinki, Finland
Site 27
🇫🇮Helsinki, Finland
Site 33
🇫🇮Järvenpää, Finland
Site 35
🇫🇮Kokkola, Finland
Site 34
🇫🇮Kotka, Finland
Site 30
🇫🇮Kuopio, Finland
Site 32
🇫🇮Seinäjoki, Finland
Site 21
🇫🇮Tampere, Finland
Site 23
🇫🇮Pori, Finland
Site 24
🇫🇮Turku, Finland
Site 49
🇵🇱Bydgoszcz, Poland
Site 28
🇫🇮Vantaa, Finland
Site 29
🇫🇮Vantaa, Finland
Site 53
🇵🇱Gniewkowo, Poland
Site 59
🇵🇱Katowice, Poland
Site 63
🇵🇱Kielce, Poland
Site 62
🇵🇱Końskie, Poland
Site 57
🇵🇱Krakow, Poland
Site 41
🇵🇱Kraków, Poland
Site 50
🇵🇱Kraków, Poland
Site 44
🇵🇱Lubartów, Poland
Site 45
🇵🇱Lublin, Poland
Site 65
🇵🇱Oleśnica, Poland
Site 48
🇵🇱Olsztyn, Poland
Site 46
🇵🇱Olsztyn, Poland
Site 58
🇵🇱Radziszów, Poland
Site 61
🇵🇱Ruda Śląska, Poland
Site 60
🇵🇱Rzeszów, Poland
Site 55
🇵🇱Wilkowice, Poland
Site 52
🇵🇱Warszawa, Poland
Site 64
🇵🇱Wrocław, Poland
Site 54
🇵🇱Wąbrzeźno, Poland
Site 51
🇵🇱Łodź, Poland
Site 13
🇺🇸Lenexa, Kansas, United States
Site 47
🇵🇱Olsztyn, Poland
Site 4
🇺🇸Edison, New Jersey, United States
Site 42
🇵🇱Kraków, Poland
Site 25
🇫🇮Espoo, Finland
Site 15
🇺🇸Pembroke Pines, Florida, United States
Site 14
🇺🇸Denver, Colorado, United States
Site 9
🇺🇸Austin, Texas, United States
Site 2
🇺🇸Bardstown, Kentucky, United States
Site 12
🇺🇸Anderson, South Carolina, United States
Site 16
🇺🇸Winston-Salem, North Carolina, United States
Site 8
🇺🇸Dallas, Texas, United States
Site 7
🇺🇸Salt Lake City, Utah, United States
Site 3
🇺🇸Salt Lake City, Utah, United States