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Completed

NCT Number: NCT00479648

A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants

Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chiltern International

Slough, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged ≥ 18 to ≤ 45 OR ≥ 60
  • Ability to provide pre-vaccination venous blood sample

Exclusion criteria

  • History of clinically significant medical conditions
  • Immunomodulative therapy
  • Acute infection

Treatment and study plan

CSL412

Biological

Inactivated trivalent influenza vaccine

Biological

Primary outcomes

  1. seroprotection rate, HI titre & seroconversion/ significant increase

  2. grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study title

A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 28, 2007
Registry last updated
Jul 19, 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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