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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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cTIV

Cell culture derived seasonal trivalent influenza vaccine (cTIV)

Group Type EXPERIMENTAL

Cell culture derived seasonal trivalent influenza vaccine (cTIV)

Intervention Type 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.

eTIV_a

Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

FLU (cTIV or eTIV_a)

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

Group Type EXPERIMENTAL

cTIV or eTIV_a

Intervention Type BIOLOGICAL

0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV\_a administered.

FLU (cTIV or eTIV_a) + PV

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).

Group Type ACTIVE_COMPARATOR

cTIV+PV OR eTIV_a+PV

Intervention Type 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).

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes