Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00579345
First received: December 19, 2007
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The Study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV_a in adults and elderly subjects.


Condition Intervention Phase
Influenza
Biological: Cell culture derived seasonal trivalent influenza vaccine (cTIV)
Biological: Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
Biological: cTIV or eTIV_a
Biological: cTIV+PV OR eTIV_a+PV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase III, Single-Blind, Multi-Center, Extension Study to Evaluate Safety and Tolerability of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adult and Elderly Subjects Who Participated in Study V58P4, With Subset Analyses of Immunogenicity and Evaluation of Concomitant Polysaccharide Pneumococcal Vaccine (Elderly).

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Randomized Participants Reporting Local and Systemic Reactions [ Time Frame: One week postvaccination ] [ Designated as safety issue: Yes ]
    Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.

  • Immunogenicity Assessment by Geometric Mean Titers (GMT) [ Time Frame: Three weeks postvaccination ] [ Designated as safety issue: No ]
    Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.


Secondary Outcome Measures:
  • Number of Unrandomized Participants Reporting Local and Systemic Reactions [ Time Frame: One week postvaccination ] [ Designated as safety issue: Yes ]
    Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.

  • Number of Randomized Participants Reporting Local and Systemic Reactions. [ Time Frame: One week postvaccination ] [ Designated as safety issue: Yes ]
    Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV).

  • Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay [ Time Frame: Three weeks postvaccination ] [ Designated as safety issue: No ]

    Immunogenicity (Seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96).

    Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10).


  • Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine [ Time Frame: Three weeks postvaccination ] [ Designated as safety issue: No ]

    Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96).

    CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is >2.5.



Enrollment: 1522
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cTIV
cell culture derived seasonal trivalent influenza vaccine (cTIV)
Biological: Cell culture derived seasonal trivalent influenza vaccine (cTIV)
cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 ml single dose in the deltoid muscle, preferably of the non-dominant arm.
Active Comparator: eTIV_a
Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)
Biological: Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 ml single dose in the deltoid muscle, preferably of the non-dominant arm.
Experimental: FLU (cTIV or eTIV_a)
Cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
Biological: cTIV or eTIV_a
0.5 ml, Single dose of either cell cultured trivalent influenza vaccine (cTIV)or egg based trivalent influenza vaccine eTIV_a administered.
Active Comparator: FLU (cTIV or eTIV_a) + PV
23-valent Pneumococcal vaccine (PV) concomitantly administered with cell culture derived seasonal trivalent influenza vaccine (cTIV); or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
Biological: cTIV+PV OR eTIV_a+PV
0.5 ml, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participation in the V58P4 study
  • mentally competent to understand the nature, the scope and the consequences of the study
  • able and willing to give written informed consent prior to study entry
  • available for all the visits scheduled in the study

Exclusion Criteria:

  • receipt of another investigational agent within 90 days prior to, or before completion of the safety follow-up period in another study, whichever is longer, prior to Visit 7 and unwilling to refuse participation in another clinical study through the end of the present study
  • history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine components
  • 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°C) within the 5 days prior to Visit 7
  • pregnant/breast feeding women, or women of childbearing potential who refuse to use a reliable contraceptive method during the three weeks after vaccination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579345

Locations
Poland
1
Krakow, Poland, 30-969
2
Krakow, Poland, 31-202
3
Krakow, Poland, 31-115
4
Krakow, Poland, 31-832
5
Krakow, Poland, 25-381
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00579345     History of Changes
Other Study ID Numbers: V58P4E2, 2006-003077-27
Study First Received: December 19, 2007
Results First Received: September 5, 2011
Last Updated: October 24, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014