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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,522

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Influenza
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).

Trial Locations (5)

25-381

5, Krakow

30-969

1, Krakow

31-115

3, Krakow

31-202

2, Krakow

31-832

4, Krakow

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY

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 | Biotech Hunter | Biotech Hunter