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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

NCT00579345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1522

Last updated 2017-01-27

Study results available
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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.

Conditions

Interventions

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.

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.

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.

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).

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00579345 on ClinicalTrials.gov