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

Influenza Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579345
• Other study ID #: V58P4E2
• Secondary ID: 2006-003077-27
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2007
• Last updated: October 24, 2012
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1522
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• 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.
• 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.
• 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).

Locations

Country	Name	City	State
Poland	1	Krakow
Poland	2	Krakow
Poland	3	Krakow
Poland	4	Krakow
Poland	5	Krakow

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Randomized Participants Reporting Local and Systemic Reactions	Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.	One week postvaccination	Yes
Primary	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.	Three weeks postvaccination	No
Secondary	Number of Unrandomized Participants Reporting Local and Systemic Reactions	Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.	One week postvaccination	Yes
Secondary	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).	One week postvaccination	Yes
Secondary	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).	Three weeks postvaccination	No
Secondary	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 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.	Three weeks postvaccination	No