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

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant; Biological: Trivalent Influenza Vaccine + high A; Biological: Trivalent Influenza Vaccine + adjuvant; Biological: Trivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine + ½ dose adjuvant; Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant; Biological: Trivalent Influenza Vaccine + high A intradermal dose; Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant; Biological: Trivalent Influenza Vaccine intradermal dose; Biological: Trivalent Influenza Vaccine + high A + adjuvant

• Registration Number: NCT00848848
• Lead Sponsor: Seqirus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
6	Trivalent Influenza Vaccine + high A + ½ dose adjuvant	-
2	Trivalent Influenza Vaccine + high A	-
7	Trivalent Influenza Vaccine + adjuvant	-
1	Trivalent Influenza Vaccine	-
5	Trivalent Influenza Vaccine + ½ dose adjuvant	-
3	Trivalent Influenza Vaccine + ¼ dose adjuvant	-
10	Trivalent Influenza Vaccine + high A intradermal dose	-
4	Trivalent Influenza Vaccine + high A + ¼ dose adjuvant	-
9	Trivalent Influenza Vaccine intradermal dose	-
8	Trivalent Influenza Vaccine + high A + adjuvant	-

Primary Outcome Measures

Name	Time	Method
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.	21 days

Secondary Outcome Measures

Name	Time	Method
Strain-specific influenza antibody titers will be used to assess Immunogenicity	21 days

Trial Locations

Locations (1)

Center For Vaccinology; 🇧🇪 Ghent, Belgium