Clinical trial NCT00630331: Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Flu
Cell Culture-Derived
Egg-Derived
Healthy Adults
Efficacy
Safety
Immunogenicity
Trivalent
Inactivated
Influenza-Like Illness
Vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 11404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains
timeFrame: 6 Months
measure: Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains
timeFrame: 6 Months
measure: Influenza-Associated Days in Bed, All Subjects
timeFrame: 6 Months
measure: Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza
timeFrame: 6 Months
measure: Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects
timeFrame: 6 Months
measure: Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza
timeFrame: 6 Months
measure: Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects
timeFrame: 6 Months
measure: Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza
timeFrame: 6 Months
measure: Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
timeFrame: Before vaccination (day 1) and three weeks after vaccination (day 22)
measure: Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
timeFrame: Three weeks after vaccination (day 22)
measure: Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
timeFrame: Up to 7 days post vaccination
Other outcomes:
Locations:
city: Denver
country: United States
facility: Site 14
state: Colorado
city: Pembroke Pines
country: United States
facility: Site 15
state: Florida
city: South Miami
country: United States
facility: Site 17
state: Florida
city: Lenexa
country: United States
facility: Site 13
state: Kansas
city: Bardstown
country: United States
facility: Site 2
state: Kentucky
city: Saint Louis
country: United States
facility: Site 1
state: Missouri
city: Edison
country: United States
facility: Site 4
state: New Jersey
city: Binghamton
country: United States
facility: Site 10
state: New York
city: Endwell
country: United States
facility: Site 5
state: New York
city: Winston-Salem
country: United States
facility: Site 16
state: North Carolina
city: Warwick
country: United States
facility: Site 11
state: Rhode Island
city: Anderson
country: United States
facility: Site 12
state: South Carolina
city: Austin
country: United States
facility: Site 9
state: Texas
city: Dallas
country: United States
facility: Site 8
state: Texas
city: Salt Lake City
country: United States
facility: Site 7
state: Utah
city: Salt Lake City
country: United States
facility: Site 3
state: Utah
city: Burke
country: United States
facility: Site 6
state: Virginia
city: Espoo
country: Finland
facility: Site 25
city: Helsinki
country: Finland
facility: Site 26
city: Helsinki
country: Finland
facility: Site 27
city: Järvenpää
country: Finland
facility: Site 33
city: Kokkola
country: Finland
facility: Site 35
city: Kotka
country: Finland
facility: Site 34
city: Kuopio
country: Finland
facility: Site 30
city: Lahti
country: Finland
facility: Site 22
city: Oulu
country: Finland
facility: Site 31
city: Pori
country: Finland
facility: Site 23
city: Seinäjoki
country: Finland
facility: Site 32
city: Tampere
country: Finland
facility: Site 21
city: Turku
country: Finland
facility: Site 24
city: Vantaa
country: Finland
facility: Site 28
city: Vantaa
country: Finland
facility: Site 29
city: Bydgoszcz
country: Poland
facility: Site 49
city: Gniewkowo
country: Poland
facility: Site 53
city: Katowice
country: Poland
facility: Site 59
city: Kielce
country: Poland
facility: Site 63
city: Końskie
country: Poland
facility: Site 62
city: Krakow
country: Poland
facility: Site 57
city: Kraków
country: Poland
facility: Site 41
city: Kraków
country: Poland
facility: Site 43
city: Kraków
country: Poland
facility: Site 42
city: Kraków
country: Poland
facility: Site 50
city: Lubartów
country: Poland
facility: Site 44
city: Lublin
country: Poland
facility: Site 45
city: Oleśnica
country: Poland
facility: Site 65
city: Olsztyn
country: Poland
facility: Site 47
city: Olsztyn
country: Poland
facility: Site 48
city: Olsztyn
country: Poland
facility: Site 46
city: Radziszów
country: Poland
facility: Site 58
city: Ruda Śląska
country: Poland
facility: Site 61
city: Rzeszów
country: Poland
facility: Site 60
city: Warszawa
country: Poland
facility: Site 52
city: Wilkowice
country: Poland
facility: Site 55
city: Wrocław
country: Poland
facility: Site 64
city: Wąbrzeźno
country: Poland
facility: Site 54
city: Łodź
country: Poland
facility: Site 51
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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.