Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

NCT ID: NCT00310804

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-04-30

Brief Summary

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Conditions

Influenza

Study Design

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

Study Groups

cTIV_lot 1

Group Type: EXPERIMENTAL

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)

Intervention Type: BIOLOGICAL

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1

cTIV_lot 2

Group Type: EXPERIMENTAL

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)

Intervention Type: BIOLOGICAL

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2

cTIV_lot 3

Group Type: EXPERIMENTAL

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)

Intervention Type: BIOLOGICAL

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3

TIV group

Group Type: ACTIVE_COMPARATOR

Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)

Intervention Type: BIOLOGICAL

One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

Interventions

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1

Intervention Type: BIOLOGICAL

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2

Intervention Type: BIOLOGICAL

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3

Intervention Type: BIOLOGICAL

Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)

One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 18 to <61 years of age

2. mentally competent to understand the nature, the scope and the consequences of the study

3. able and willing to give written informed consent prior to study entry

4. in good health as determined by:

1. medical history,

2. physical examination,

3. clinical judgment of the Investigator.

Exclusion Criteria

1. unwilling or unable to give written informed consent to participate in the study

2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study

3. currently experiencing an acute infectious disease

4. any serious disease, such as, for example:

1. cancer,

2. autoimmune disease (including rheumatoid arthritis),

3. advanced arteriosclerotic disease or complicated diabetes mellitus,

4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,

5. acute or progressive hepatic disease,

6. acute or progressive renal disease,

7. congestive heart failure

5. surgery planned during the study period

6. bleeding diathesis

7. history of hypersensitivity to any component of the study medication or chemically related substances

8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component

9. known or suspected impairment/alteration of immune function, for example resulting from:

1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),

2. receipt of immunostimulants,

3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,

4. high risk for developing an immunocompromising disease

10. history of drug or alcohol abuse

11. laboratory-confirmed influenza disease within 6 months prior to Visit 1

12. receipt of influenza vaccine within 6 months prior to Visit 1

13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination

14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1

15. if female, pregnant or breastfeeding

16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination

17. planned relocation abroad during the study period

18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 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 & Diagnostics

Locations

2nd Department of Internal Diseases, Panevezys Hospital,

Panevezys, , Lithuania

Dept. Infectious Diseases and Microbiology of Vilnius University

Vilnius, , Lithuania

Countries

Lithuania

References

Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 Aug 8.

Reference Type: RESULT

PMID: 19666152 (View on PubMed)

Other Identifiers

EUDRACT: 2005-002257-47

Identifier Type: -

Identifier Source: secondary_id

V58P9

Identifier Type: -

Identifier Source: org_study_id