This is a randomized, double-blinded, placebo-controlled, staged, dose-ranging, Phase I/II study to evaluate the safety, reactogenicity, and immunogenicity of 2 doses of an IM inactivated influenza A/H5N1 vaccine in healthy children, aged 2 through 9 years. This study is designed to investigate the safety, tolerability, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 vaccine. A secondary goal is to identify an optimal dosage level of the vaccine that generates an acceptable immunogenic response, while maintaining an adequate safety profile.

Condition	Intervention	Phase
Influenza	Vaccine: Influenza A/H5N1 Vaccine	Phase I Phase II

Further Study Details: 

Expected Total Enrollment:  240

This is a randomized, double-blinded, placebo-controlled, staged, dose-ranging, Phase I/II study to evaluate the safety, reactogenicity, and immunogenicity of 2 doses of an IM inactivated influenza A/H5N1 vaccine in healthy children, aged 2 through 9 years. This study is designed to investigate the safety, tolerability, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 vaccine. A secondary goal is to identify an optimal dosage level of the vaccine that generates an acceptable immunogenic response, while maintaining an adequate safety profile.

Ages Eligible for Study:  2 Years   -   9 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in this study and must also meet these criteria prior to receiving each vaccination:

1. The subject must be male or female, aged 2 through 9 years.
2. The subject must be in good health, as determined by medical history and a targeted physical examination.
3. Parents or guardians must be able to understand and comply with planned study procedures and be available for all study visits.
4. Parents or guardians must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Exclusion Criteria:

Subjects must not meet any of the following exclusion criteria at baseline or prior to each injection, or they will be excluded from study participation:

1. The subject must not have a known allergy to eggs or other components of the vaccine.
2. The subject must not have a history of asthma or recurrent wheezing.
3. The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.
4. The subject must not have an active neoplastic disease or a history of any hematologic malignancy.
5. The subject must not be using oral or parenteral steroids, inhaled steroids or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal steroids will be allowed to enroll in this study.
6. The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
7. The subject must not have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
8. The subject must not have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
9. The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines.
10. The subject must not have an acute illness, including an oral temperature greater than 100 degrees F, within 3 days prior to vaccination.
11. The subject must not have received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 7-month study period.
12. The subject must not have any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Please refer to this study by ClinicalTrials.gov identifier  NCT00133536

Margaret Rennels      (410) 706-8695    mrennels@peds.umaryland.edu

California
      UCLA Center For Vaccine Research, Torrance,  California,  90502,  United States
Maryland
      University of Maryland School of Medicine, Baltimore,  Maryland,  21201,  United States
Missouri
      Saint Louis University Health Sciences Center, St. Louis,  Missouri,  63110,  United States
Ohio
      Cincinnati Children''''s Hospital Medical Center, Cincinnati,  Ohio,  45231,  United States

Study ID Numbers:  04-077
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133536
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23