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

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00579345

2006-003077-27

V58P4E2

Details and patient eligibility

About

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.

Enrollment: 1,522 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,522 participants in 4 patient groups

cTIV

Experimental group

Description:

Cell culture derived seasonal trivalent influenza vaccine (cTIV)

Treatment:

Biological: Cell culture derived seasonal trivalent influenza vaccine (cTIV)

eTIV_a

Active Comparator group

Description:

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

Treatment:

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

FLU (cTIV or eTIV_a)

Experimental group

Description:

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

Treatment:

Biological: cTIV or eTIV_a

FLU (cTIV or eTIV_a) + PV

Active Comparator group

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).

Treatment:

Biological: cTIV+PV OR eTIV_a+PV