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OpenTrials
Completed

NCT Number: NCT00561184

Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test

Completed

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Key information

Conditions

Avian Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Orthomyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini, Chieti, Italy

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202

Exclusion criteria

  • Pregnant or breastfeeding
  • Receipt of another vaccine or any investigational agent within the past 4 weeks
  • Surgery planned during the study period

Treatment and study plan

H5N1 Influenza Vaccine

Biological

One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen

Primary outcomes

  1. Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.

    Time frame: 7 days

  2. Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.

    Time frame: 7 days

Secondary outcomes

  1. Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines.

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Nov 20, 2007
Registry last updated
Dec 1, 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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