Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

3,647

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

November 30, 2009

Conditions
Pandemic Influenza Disease
Interventions
BIOLOGICAL

Placebo (PL)

One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm.

BIOLOGICAL

Trivalent influenza virus vaccine (TIV)

A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm.

BIOLOGICAL

Adjuvanted monovalent influenza virus vaccine (aH5N1)

Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle.

BIOLOGICAL

Adjuvanted trivalent influenza virus vaccine (aTIV)

Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle.

Trial Locations (2)

33100

Tampere Vaccine Research Clinic (15 sites), Tampere

80799

12 Sites, München

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY

NCT00841763 - Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects | Biotech Hunter | Biotech Hunter