Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

NCT ID: NCT00306527

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-04-30

Brief Summary

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.

Conditions

Influenza

Study Design

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

Study Groups

cTIV\cTIV (adults)

Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

Cell culture derived influenza vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

cTIV\TIV (adults)

Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

egg-derived influenza subunit vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

cTIV\cTIV (elderly)

Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

Cell culture derived influenza vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

cTIV\TIV (elderly)

Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

egg-derived influenza subunit vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

TIV\TIV (adults)

Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

egg-derived influenza subunit vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

TIV\cTIV (adults)

Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

Cell culture derived influenza vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

TIV\TIV (elderly)

Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

egg-derived influenza subunit vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

TIV\cTIV (elderly)

Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.

Group Type: ACTIVE_COMPARATOR

Cell culture derived influenza vaccine

Intervention Type: BIOLOGICAL

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

Interventions

Cell culture derived influenza vaccine

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

Intervention Type: BIOLOGICAL

egg-derived influenza subunit vaccine

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 18 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4

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. Available for all the visits scheduled in the study

5. in good health as determined by:

1. Medical history related to the previous six months,

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. Currently experiencing an acute infectious disease

3. Any serious disease such as, for example:

1. Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)

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

4. Surgery planned during the study period

5. Bleeding diathesis

6. History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products

7. Known or suspected impairment/alteration of immune function resulting from:

1. Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)

2. Receipt of immunostimulants

3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study

4. High risk for developing an immunocompromising disease

8. History of drug or alcohol abuse

9. Laboratory confirmed influenza disease in the past 6 months

10. Received influenza vaccine within the past 6 months

11. Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination

12. Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study

13. Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days

14. Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination

15. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

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

Sponsors

Novartis Vaccines and Diagnostics S.r.l.

UNKNOWN

Sponsor Role: collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Wojewódzki Szpital Dzieci_cy

Ul. Langiewicza 2, Kielce, Poland

Centrum Bada_ Farmakologii Klinicznej

Ul. Ujastek 3, Krakow, Poland

NZOZ Jagiello_skie

Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1, Kraków, Poland

NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.

Pl. Sikorskiego 6a, Kraków, Poland

Szpital Jana Pawła II, Oddz. Neuroinfekcji

Ul. Pr_dnicka 80, Kraków, Poland

Countries

Poland

References

Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.

Reference Type: RESULT

PMID: 22418809 (View on PubMed)

Other Identifiers

EUDRACT: 2005-001902-26

Identifier Type: -

Identifier Source: secondary_id

V58P4E1

Identifier Type: -

Identifier Source: org_study_id