Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
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
3 other identifiers
interventional
11,404
3 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
Shorter than P25 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
January 16, 2013
CompletedMay 24, 2024
May 1, 2024
9 months
February 28, 2008
November 21, 2012
May 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
6 Months
Secondary Outcomes (11)
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains
6 Months
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains
6 Months
Influenza-Associated Days in Bed, All Subjects
6 Months
Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza
6 Months
Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects
6 Months
- +6 more secondary outcomes
Study Arms (3)
CCI
EXPERIMENTALSubjects received one dose of cell culture-derived influenza vaccine.
IVV
EXPERIMENTALSubjects received one dose of the trivalent egg-derived influenza vaccine.
Placebo
PLACEBO COMPARATORSubjects received one dose of phosphate buffered solution (PBS).
Interventions
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Site 14
Denver, Colorado, 80212, United States
Site 15
Pembroke Pines, Florida, 33024, United States
Site 17
South Miami, Florida, 33143, United States
Site 13
Lenexa, Kansas, 66219, United States
Site 2
Bardstown, Kentucky, 40004, United States
Site 1
St Louis, Missouri, 63140, United States
Site 4
Edison, New Jersey, 08817, United States
Site 10
Binghamton, New York, 13901, United States
Site 5
Endwell, New York, 13760, United States
Site 16
Winston-Salem, North Carolina, 27103, United States
Site 11
Warwick, Rhode Island, 02886, United States
Site 12
Anderson, South Carolina, 29621, United States
Site 9
Austin, Texas, 78705, United States
Site 8
Dallas, Texas, 75234, United States
Site 7
Salt Lake City, Utah, 84109, United States
Site 3
Salt Lake City, Utah, 84121, United States
Site 6
Burke, Virginia, 22105, United States
Site 25
Espoo, 02100, Finland
Site 26
Helsinki, 00100, Finland
Site 27
Helsinki, 00930, Finland
Site 33
Jarvenpaa, 04400, Finland
Site 35
Kokkola, 67100, Finland
Site 34
Kotka, 48600, Finland
Site 30
Kuopio, 70100, Finland
Site 22
Lahti, 15140, Finland
Site 31
Oulu, 90100, Finland
Site 23
Pori, 28120, Finland
Site 32
Seinäjoki, 60100, Finland
Site 21
Tampere, 33100, Finland
Site 24
Turku, 20520, Finland
Site 28
Vantaa, 01300, Finland
Site 29
Vantaa, 01600, Finland
Site 49
Bydgoszcz, 85-316, Poland
Site 62
Gmina Końskie, 26-200, Poland
Site 53
Gniewkowo, 88-140, Poland
Site 59
Katowice, 40-084, Poland
Site 63
Kielce, 25-711, Poland
Site 57
Krakow, 30-510, Poland
Site 41
Krakow, 30-969, Poland
Site 43
Krakow, 31-115, Poland
Site 42
Krakow, 31-503, Poland
Site 50
Krakow, 31-832, Poland
Site 44
Lubartów, 21 - 100, Poland
Site 45
Lublin, 20-044, Poland
Site 65
Oleśnica, 56-400, Poland
Site 47
Olsztyn, 10-117, Poland
Site 48
Olsztyn, 10-295, Poland
Site 46
Olsztyn, 10-461, Poland
Site 58
Radziszów, 32-052, Poland
Site 61
Ruda Śląska, 41-703, Poland
Site 60
Rzeszów, 35-324, Poland
Site 52
Warsaw, 02-777, Poland
Site 54
Wąbrzeźno, 87-200, Poland
Site 55
Wilkowice, 43-365, Poland
Site 64
Wroclaw, 51-312, Poland
Site 51
Łodź, 90-302, Poland
Related Publications (1)
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.
PMID: 20868284RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
October 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
May 24, 2024
Results First Posted
January 16, 2013
Record last verified: 2024-05