A/H5N1 Vaccine in Healthy Children Aged 2-9 Years

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccination. To look at immune system responses, researchers will test the children's blood before and a number of times after vaccination. Participants will include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive 2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least 2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response from a third vaccination, children will be offered a third dose of the vaccine. Participants will be involved in study related procedures for up to 13 months, including up to 6 study visits, plus a number of telephone calls.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• The subject must be male or female, aged 2 through 9 years at enrollment.

• The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination.

• Parents or guardians must be able to understand and comply with planned study procedures and be available for all study visits.

• Parents or guardians must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Exclusion Criteria:

• The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.

• The subject must not have a history of asthma or recurrent wheezing.

• The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.

• The subject must not have an active neoplastic disease or a history of any hematologic malignancy.

• The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.

• The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.

• 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.

• 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).

• The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines.

• The subject must not have an acute illness, including an axillary temperature greater than 100 degrees F, within 3 days prior to vaccination.

• The subject must not have received an experimental vaccine or medication within one month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 13-month study period.

• 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.

• History of Guillain-Barré syndrome.

• The subject must not be participating concurrently in another clinical trial (either in active phase or in follow-up phase).