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

Seqirus

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Trivalent Influenza Vaccine + high A + adjuvant; Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant; Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant; Biological: Trivalent Influenza Vaccine + high A intradermal dose; Biological: Trivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant; Biological: Trivalent Influenza Vaccine + ½ dose adjuvant; Biological: Trivalent Influenza Vaccine + high A; Biological: Trivalent Influenza Vaccine + adjuvant; Biological: Trivalent Influenza Vaccine intradermal dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848848

2008-002625-36

V104P3

Details and patient eligibility

About

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Enrollment: 450 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.

Exclusion criteria

• Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
• Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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450 participants in 10 patient groups

1

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine

2

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + high A

3

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant

4

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

5

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + ½ dose adjuvant

6

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant

7

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + adjuvant

8

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + high A + adjuvant

9

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine intradermal dose

10

Active Comparator group

Treatment:

Biological: Trivalent Influenza Vaccine + high A intradermal dose