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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630331
• Other study ID #: V58P13
• Secondary ID: 2007-002871-1511
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11404
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Cell culture-derived influenza vaccine
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
• Egg-derived influenza virus vaccine
One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
• Placebo
One dose (0.5 mL) of phosphate buffered solution.

Locations

Country	Name	City	State
Finland	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
Poland	Site 49	Bydgoszcz
Poland	Site 53	Gniewkowo
Poland	Site 59	Katowice
Poland	Site 63	Kielce
Poland	Site 62	Konskie
Poland	Site 57	Krakow
Poland	Site 41	Kraków
Poland	Site 42	Kraków
Poland	Site 43	Kraków
Poland	Site 50	Kraków
Poland	Site 51	Lodz
Poland	Site 44	Lubartów
Poland	Site 45	Lublin
Poland	Site 65	Olesnica
Poland	Site 46	Olsztyn
Poland	Site 47	Olsztyn
Poland	Site 48	Olsztyn
Poland	Site 58	Radziszów
Poland	Site 61	Ruda Slaska
Poland	Site 60	Rzeszów
Poland	Site 54	Wabrzezno
Poland	Site 52	Warszawa
Poland	Site 55	Wilkowice
Poland	Site 64	Wroclaw
United States	Site 12	Anderson	South Carolina
United States	Site 9	Austin	Texas
United States	Site 2	Bardstown	Kentucky
United States	Site 10	Binghamton	New York
United States	Site 6	Burke	Virginia
United States	Site 8	Dallas	Texas
United States	Site 14	Denver	Colorado
United States	Site 4	Edison	New Jersey
United States	Site 5	Endwell	New York
United States	Site 13	Lenexa	Kansas
United States	Site 15	Pembroke Pines	Florida
United States	Site 1	Saint Louis	Missouri
United States	Site 3	Salt Lake City	Utah
United States	Site 7	Salt Lake City	Utah
United States	Site 17	South Miami	Florida
United States	Site 11	Warwick	Rhode Island
United States	Site 16	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Finland,  Poland, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-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 A or B illness caused by non-vaccine-like strains.	6 Months
Secondary	Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains	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
Secondary	Influenza-Associated Days in Bed, All Subjects	The number of subjects in this analysis included all subjects in the per protocol efficacy population.	6 Months
Secondary	Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza	The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.	6 Months
Secondary	Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects	The number of subjects in this analysis included all subjects in the per protocol efficacy population.	6 Months
Secondary	Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza	The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.	6 Months
Secondary	Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects	The number of subjects in this analysis included all subjects in the per protocol efficacy population.	6 Months
Secondary	Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza	The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.	6 Months
Secondary	Percentages of Subjects Who Achieved HI Titers =40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo	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)
Secondary	Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo	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)
Secondary	Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After 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