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OpenTrials
Completed

NCT Number: NCT00559975

Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine

To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.

Completed

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Key information

Conditions

Influenza Infection

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute for Pharmacokinetic and Analytical Studies

Ligornetto, 6853, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects aged 18 to ≤40 years

Exclusion criteria

  • Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid.
  • Abnormal TSH from blood samples collected during the screening visit;

Treatment and study plan

Subunit influenza vaccine

Biological

0.5 mL single dose vaccine

Adjuvanted Influenza Vaccine

Biological

0.5 mL single dose vaccine

Adjuvanted influenza vaccine combined with CpG7909

Biological

0.5 ml influenza vaccine combined with 10 mcg of CpG7909

Adjuvanted influenza vaccine combine with CpG7909

Biological

0.5 mL single dose vaccine combined with 30 mcg of CpG7909

Primary outcomes

  1. Measures of humoral immunogenicity for each antigen

    Time frame: 22 days

Secondary outcomes

  1. Measures of vaccine-induced B and T cell immune responses

    Time frame: 72 hours

  2. Measure of alterated biomarkers and measure of safety

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

A Phase 1, Randomized, Controlled, Observer-Blinded, Dose Escalation Study of the Safety, Tolerability and Immunogenicity of a Single Dose of Adjuvanted Influenza Vaccine Combined With CpG7909 in Healthy Adults

Important dates

Study start
2007
Study completion
2008
First posted
Nov 19, 2007
Registry last updated
Nov 5, 2009

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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