Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

PHASE1CompletedINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Influenza
Interventions
BIOLOGICAL

Trivalent Influenza Vaccine

1 dose of Trivalent Influenza Vaccine

BIOLOGICAL

Trivalent Influenza Vaccine + high A

1 dose of Trivalent Influenza Vaccine with high A content

BIOLOGICAL

Trivalent Influenza Vaccine + ¼ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + ½ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + adjuvant

1 dose of Trivalent Influenza Vaccine plus adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + high A + adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine intradermal dose

1 dose of Trivalent Influenza Vaccine intradermal dose

BIOLOGICAL

Trivalent Influenza Vaccine + high A intradermal dose

1 intradermal dose of Trivalent Influenza Vaccine + high A

Trial Locations (1)

9000

Center For Vaccinology, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Seqirus

INDUSTRY