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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1, Krakow, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cell culture derived seasonal trivalent influenza vaccine (cTIV)

Biological

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).

Biological

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

Biological

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

Biological

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 outcomes

  1. Number of Randomized Participants Reporting Local and Systemic Reactions.

    Time frame: One week postvaccination

    Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.

  2. Immunogenicity Assessment by Geometric Mean Titers (GMT).

    Time frame: Three weeks postvaccination

    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 outcomes

  1. Number of Unrandomized Participants Reporting Local and Systemic Reactions.

    Time frame: One week postvaccination

    Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.

  2. Number of Randomized Participants Reporting Local and Systemic Reactions.

    Time frame: One week postvaccination

    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.

  3. Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.

    Time frame: Three weeks postvaccination

    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).

  4. Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.

    Time frame: Three weeks postvaccination

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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).

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 24, 2007
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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