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

NCT ID: NCT00630331

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-07-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CCI

Subjects received one dose of cell culture-derived influenza vaccine.

Group Type: EXPERIMENTAL

Cell culture-derived influenza vaccine

Intervention Type: BIOLOGICAL

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

IVV

Subjects received one dose of the trivalent egg-derived influenza vaccine.

Group Type: EXPERIMENTAL

Egg-derived influenza virus vaccine

Intervention Type: BIOLOGICAL

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

Placebo

Subjects received one dose of phosphate buffered solution (PBS).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

One dose (0.5 mL) of phosphate buffered solution.

Interventions

Cell culture-derived influenza vaccine

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

Intervention Type: BIOLOGICAL

Egg-derived influenza virus vaccine

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

Intervention Type: BIOLOGICAL

Placebo

One dose (0.5 mL) of phosphate buffered solution.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Site 14

Denver, Colorado, United States

Site 15

Pembroke Pines, Florida, United States

Site 17

South Miami, Florida, United States

Site 13

Lenexa, Kansas, United States

Site 2

Bardstown, Kentucky, United States

Site 1

St Louis, Missouri, United States

Site 4

Edison, New Jersey, United States

Site 10

Binghamton, New York, United States

Site 5

Endwell, New York, United States

Site 16

Winston-Salem, North Carolina, United States

Site 11

Warwick, Rhode Island, United States

Site 12

Anderson, South Carolina, United States

Site 9

Austin, Texas, United States

Site 8

Dallas, Texas, United States

Site 7

Salt Lake City, Utah, United States

Site 3

Salt Lake City, Utah, United States

Site 6

Burke, Virginia, United States

Site 25

Espoo, , Finland

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 22

Lahti, , Finland

Site 31

Oulu, , Finland

Site 23

Pori, , Finland

Site 32

Seinäjoki, , Finland

Site 21

Tampere, , Finland

Site 24

Turku, , Finland

Site 28

Vantaa, , Finland

Site 29

Vantaa, , Finland

Site 49

Bydgoszcz, , Poland

Site 62

Gmina Końskie, , Poland

Site 53

Gniewkowo, , Poland

Site 59

Katowice, , Poland

Site 63

Kielce, , Poland

Site 57

Krakow, , Poland

Site 41

Krakow, , Poland

Site 43

Krakow, , Poland

Site 42

Krakow, , Poland

Site 50

Krakow, , Poland

Site 44

Lubartów, , Poland

Site 45

Lublin, , Poland

Site 65

Oleśnica, , Poland

Site 47

Olsztyn, , Poland

Site 48

Olsztyn, , Poland

Site 46

Olsztyn, , Poland

Site 58

Radziszów, , Poland

Site 61

Ruda Śląska, , Poland

Site 60

Rzeszów, , Poland

Site 52

Warsaw, , Poland

Site 54

Wąbrzeźno, , Poland

Site 55

Wilkowice, , Poland

Site 64

Wroclaw, , Poland

Site 51

Łodź, , Poland

Countries

United States; Finland; Poland

References

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.

Reference Type: RESULT

PMID: 20868284 (View on PubMed)

Other Identifiers

2007-002871-15

Identifier Type: -

Identifier Source: secondary_id

11580

Identifier Type: -

Identifier Source: secondary_id

V58P13

Identifier Type: -

Identifier Source: org_study_id