Clinical trial NCT00579345: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-12-24
Enrollment: 1522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Randomized Participants Reporting Local and Systemic Reactions.
timeFrame: One week postvaccination
measure: Immunogenicity Assessment by Geometric Mean Titers (GMT).
timeFrame: Three weeks postvaccination
Secondary outcomes:
measure: Number of Unrandomized Participants Reporting Local and Systemic Reactions.
timeFrame: One week postvaccination
measure: Number of Randomized Participants Reporting Local and Systemic Reactions.
timeFrame: One week postvaccination
measure: Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
timeFrame: Three weeks postvaccination
measure: Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
timeFrame: Three weeks postvaccination
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: 5
city: Krakow
country: Poland
facility: 1
city: Krakow
country: Poland
facility: 3
city: Krakow
country: Poland
facility: 2
city: Krakow
country: Poland
facility: 4
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
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.