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OpenTrials
Completed

NCT Number: NCT00848848

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

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center For Vaccinology

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trivalent Influenza Vaccine

Biological

1 dose of Trivalent Influenza Vaccine

Trivalent Influenza Vaccine + high A

Biological

1 dose of Trivalent Influenza Vaccine with high A content

Trivalent Influenza Vaccine + ¼ dose adjuvant

Biological

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

Biological

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

Trivalent Influenza Vaccine + ½ dose adjuvant

Biological

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

Biological

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

Trivalent Influenza Vaccine + adjuvant

Biological

1 dose of Trivalent Influenza Vaccine plus adjuvant

Trivalent Influenza Vaccine + high A + adjuvant

Biological

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

Trivalent Influenza Vaccine intradermal dose

Biological

1 dose of Trivalent Influenza Vaccine intradermal dose

Trivalent Influenza Vaccine + high A intradermal dose

Biological

1 intradermal dose of Trivalent Influenza Vaccine + high A

Primary outcomes

  1. Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.

    Time frame: 21 days

Secondary outcomes

  1. Strain-specific influenza antibody titers will be used to assess Immunogenicity

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2009
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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