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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848848
• Other study ID #: V104P3
• Secondary ID: 2008-002625-36
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2009
• Last updated: May 5, 2016
• Start date: October 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2016
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Paul-Ehrlich-InstitutPoland: CEBK
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent Influenza Vaccine
1 dose of Trivalent Influenza Vaccine
• Trivalent Influenza Vaccine + high A
1 dose of Trivalent Influenza Vaccine with high A content
• Trivalent Influenza Vaccine + ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
• Trivalent Influenza Vaccine + high A + ¼ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
• Trivalent Influenza Vaccine + ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
• Trivalent Influenza Vaccine + high A + ½ dose adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
• Trivalent Influenza Vaccine + adjuvant
1 dose of Trivalent Influenza Vaccine plus adjuvant
• Trivalent Influenza Vaccine + high A + adjuvant
1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
• Trivalent Influenza Vaccine intradermal dose
1 dose of Trivalent Influenza Vaccine intradermal dose
• Trivalent Influenza Vaccine + high A intradermal dose
1 intradermal dose of Trivalent Influenza Vaccine + high A

Locations

Country	Name	City	State
Belgium	Center For Vaccinology	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
Seqirus	Novartis Vaccines

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.		21 days	Yes
Secondary	Strain-specific influenza antibody titers will be used to assess Immunogenicity		21 days	No