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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Cell culture derived seasonal trivalent influenza vaccine (cTIV)
Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
cTIV or eTIV_a
cTIV+PV OR eTIV_a+PV
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 was 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

Sites / Locations

  • 5
  • 1
  • 3
  • 2
  • 4

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

cTIV

eTIV_a

FLU (cTIV or eTIV_a)

FLU (cTIV or eTIV_a) + PV

Arm Description

Cell culture derived seasonal trivalent influenza vaccine (cTIV)

Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)

Cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).

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).

Outcomes

Primary Outcome Measures

Number of Randomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Immunogenicity Assessment by Geometric Mean Titers (GMT).
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.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
Number of Randomized Participants Reporting Local and Systemic Reactions.
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)). Local reactions reported for Influenza Vaccine Injection Site.
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
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.
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 CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5.

Full Information

First Posted
December 19, 2007
Last Updated
November 30, 2016
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00579345
Brief Title
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
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).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cTIV
Arm Type
Experimental
Arm Description
Cell culture derived seasonal trivalent influenza vaccine (cTIV)
Arm Title
eTIV_a
Arm Type
Active Comparator
Arm Description
Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)
Arm Title
FLU (cTIV or eTIV_a)
Arm Type
Experimental
Arm Description
Cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
Arm Title
FLU (cTIV or eTIV_a) + PV
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Cell culture derived seasonal trivalent influenza vaccine (cTIV)
Intervention Description
cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
Intervention Description
egg based trivalent influenza vaccine (eTIV_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
cTIV or eTIV_a
Intervention Description
0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV_a administered.
Intervention Type
Biological
Intervention Name(s)
cTIV+PV OR eTIV_a+PV
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Randomized Participants Reporting Local and Systemic Reactions.
Description
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Time Frame
One week postvaccination
Title
Immunogenicity Assessment by Geometric Mean Titers (GMT).
Description
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.
Time Frame
Three weeks postvaccination
Secondary Outcome Measure Information:
Title
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Description
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
Time Frame
One week postvaccination
Title
Number of Randomized Participants Reporting Local and Systemic Reactions.
Description
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)). Local reactions reported for Influenza Vaccine Injection Site.
Time Frame
One week postvaccination
Title
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
Description
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).
Time Frame
Three weeks postvaccination
Title
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
Description
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 CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5.
Time Frame
Three weeks postvaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 was 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
5
City
Krakow
ZIP/Postal Code
25-381
Country
Poland
Facility Name
1
City
Krakow
ZIP/Postal Code
30-969
Country
Poland
Facility Name
3
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
2
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
4
City
Krakow
ZIP/Postal Code
31-832
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22418809
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=22418809
Description
Related Info

Learn more about this trial

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

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