Influenza Clinical Trial
Official title:
A Comparison of One Versus Two Doses of Influenza Vaccine in Children Aged 5-8 Years of Age Receiving Influenza Vaccine for the First Time
Verified date | October 2017 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study was to find out if children 5 through 8 years of age who are getting influenza vaccine for the first time should get one or two doses.
Status | Completed |
Enrollment | 280 |
Est. completion date | December 2004 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility |
Inclusion Criteria: - Immunocompetent children who are at least 5 and no more than 8 years of age on the date of the first vaccination. - Parents able to give informed consent and child available for all study visits. - Family able to understand and comply with planned study procedures. - Family must have telephone accessibility. Exclusion Criteria: - Previous receipt of influenza vaccine of any kind (shot or nasal spray). - Active cancer or blood system abnormalities such as leukemia. - Immunocompromising illnesses or current receipt of immunosuppressive agents - Allergy to eggs or egg protein, or to gentamicin (an antibiotic that is present in trace amounts in the vaccine). - Any acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses. Temporary Exclusion Criteria: Acute disease, defined as the presence of moderate or severe illness with or without fever, at the time of enrollment. Influenza vaccine may be administered to children with minor illnesses, such as diarrhea, mild upper respiratory infection and low-grade febrile illness with an oral temperature <100.4 F. |
Country | Name | City | State |
---|---|---|---|
United States | Group Health Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Centers for Disease Control and Prevention |
United States,
Neuzil KM, Jackson LA, Nelson J, Klimov A, Cox N, Bridges CB, Dunn J, DeStefano F, Shay D. Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. J Infect Dis. 2006 Oct 15;1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of antibody response after 1 dose of influenza vaccine with that after 2 doses of influenza vaccine. | Blood samples were obtained at 3 time points, before dose 1 of vaccine, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2 of vaccine. | ||
Secondary | To describe and compare the safety profile after 1 and 2 doses of vaccine. | Study diaries were kept from the day of vaccination daily for the 4 days after vaccination. |
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