Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children

Completed · Phase 2

Conditions studied: Pandemic H5N1 Influenza

In brief

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.

Key facts

Study ID

NCT01776554

Run by

Novartis Vaccines

People needed

662

Starts

2013-01-01

Expected to finish

2014-06-01

Last updated by the study team

2019-01-16

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy pediatric subjects 6 months to 17 years of age,
• Individuals' parent(s) or legal guardian(s) willing to provide written informed consent,
• Individuals in good health,
• Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period,
• Individuals willing to provide informed assent (where applicable).

You may not qualify if…

• Individuals' parent(s)/legal guardian(s) not able to understand and follow study procedures,
• History of any significant illness,
• History of any chronic medical condition or progressive disease,
• Presence of medically significant cancer,
• Known or suspected impairment/alteration of immune function,
• Presence of any progressive or severe neurologic disorder,
• Presence of any bleeding disorders or conditions that prolongs bleeding time,
• History of allergy to vaccine components,
• Receipt of any other investigational product within 30 days prior to entry into the study,
• History of previous H5N1 vaccination,
• Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
• Receipt of any other vaccine within 2 weeks prior to entry into the study,
• Body temperature ≥38°C (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
• Pregnant or breast feeding,
• Females of childbearing potential refusing to use acceptable method of birth control,
• Body mass index (BMI) ≥ 35 kg/m2,
• History of drug or alcohol abuse,
• Any planned surgery during study period,
• Individuals conducting the study and their immediate family members,
• Individuals with behavioral or cognitive impairment or psychiatric diseases,
• Individuals diagnosed with any growth disorders.

Where it is running

• 3 Meridian Clinical Research — Miami, Florida, United States
• 7 Heartland Research Associates — Newton, Kansas, United States
• 5 Heartland Research Associates — Wichita, Kansas, United States
• 9 Heartland Research Associates — Wichita, Kansas, United States
• 1 Saint Louis University — St Louis, Missouri, United States
• 6 Meridian Clinical Research — Omaha, Nebraska, United States
• 10 Tekton Research — Georgetown, Texas, United States
• 8 Foothill Family Clinic — Salt Lake City, Utah, United States
• 4 Foothill Family Clinic — South Cottonwood Heights, Utah, United States
• 2 Rockwood Clinic P S — Spokane, Washington, United States
• 75 Phramongkutklao Hospital — Bangkok, Thailand
• 76 Faculty of Tropical Medicine Mahidol University — Bangkok, Thailand

Full record on ClinicalTrials.gov

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