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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Cell culture derived influenza vaccine; Biological: egg-derived influenza subunit vaccine

• Registration Number: NCT00306527
• Lead Sponsor: Novartis Vaccines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2005-12
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-24
• Study Completion: 2006-04
• Results First Submitted: 2012-12-06
• Results First Submitted QC: 2012-12-06
• Results First Posted: 2013-01-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2235

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cTIV\cTIV (adults)	Cell culture derived influenza vaccine	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.
cTIV\cTIV (elderly)	Cell culture derived influenza vaccine	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.
TIV\cTIV (adults)	Cell culture derived influenza vaccine	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.
TIV\cTIV (elderly)	Cell culture derived influenza vaccine	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.
cTIV\TIV (adults)	egg-derived influenza subunit vaccine	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.
cTIV\TIV (elderly)	egg-derived influenza subunit vaccine	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.
TIV\TIV (elderly)	egg-derived influenza subunit vaccine	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.
TIV\TIV (adults)	egg-derived influenza subunit vaccine	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine	Day 1 to Day 7 postvaccination	To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .

Secondary Outcome Measures

Name	Time	Method
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine	Up to 6 months postvaccination	To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study.
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects	Day 22 postvaccination	The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs.; The HI GMTs were evaluated using egg-derived antigen assay.
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects	Day 22 postvaccination	Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.; The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.	Day 22 postvaccination	Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.; European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is \> 70% for adults and \>60% for elderly.
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.	Day 22 postvaccination	Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine.; Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer.

Trial Locations

Locations (5)

Centrum Bada_ Farmakologii Klinicznej; 🇵🇱 Ul. Ujastek 3, Krakow, Poland

NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.; 🇵🇱 Pl. Sikorskiego 6a, Kraków, Poland

Wojewódzki Szpital Dzieci_cy; 🇵🇱 Ul. Langiewicza 2, Kielce, Poland

NZOZ Jagiello_skie; 🇵🇱 Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1, Kraków, Poland

Szpital Jana Pawła II, Oddz. Neuroinfekcji; 🇵🇱 Ul. Pr_dnicka 80, Kraków, Poland