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

A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00848848

Enrollment

450

Registered

2009-02-20

Start date

2008-10-31

Completion date

2009-04-30

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Flu, Vaccine, Intradermal, Adjuvant

Brief summary

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

Interventions

BIOLOGICALTrivalent Influenza Vaccine

1 dose of Trivalent Influenza Vaccine

BIOLOGICALTrivalent Influenza Vaccine + high A

1 dose of Trivalent Influenza Vaccine with high A content

BIOLOGICALTrivalent Influenza Vaccine + ¼ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

BIOLOGICALTrivalent Influenza Vaccine + high A + ¼ dose adjuvant

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

BIOLOGICALTrivalent Influenza Vaccine + ½ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

BIOLOGICALTrivalent Influenza Vaccine + high A + ½ dose adjuvant

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

BIOLOGICALTrivalent Influenza Vaccine + adjuvant

1 dose of Trivalent Influenza Vaccine plus adjuvant

BIOLOGICALTrivalent Influenza Vaccine + high A + adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

BIOLOGICALTrivalent Influenza Vaccine intradermal dose

1 dose of Trivalent Influenza Vaccine intradermal dose

BIOLOGICALTrivalent Influenza Vaccine + high A intradermal dose

1 intradermal dose of Trivalent Influenza Vaccine + high A

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Strain-specific influenza antibody titers will be used to assess Immunogenicity	21 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026