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Completed

NCT Number: NCT00537524

Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination

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Key information

Conditions

Prophylaxis of Avian Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Tampere Medical School

Tampere, 33014, Finland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects

Exclusion criteria

  • Receipt of Seasonal Influenza Vaccine for season 2007/2008
  • Receipt of another vaccine within 3 weeks before and after each vaccination
  • Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant
  • Children who are in the local recommendation for influenza vaccination due to underlying diseases

Treatment and study plan

H5N1 Influenza Vaccine

Biological

Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).

Primary outcomes

  1. safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart

    Time frame: administered 3 weeks apart

Secondary outcomes

  1. safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1

    Time frame: 12 months after primary immunization

  2. safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies

    Time frame: 12 months after primary immunization

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Oct 1, 2007
Registry last updated
Feb 16, 2012

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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