Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Influenza, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 4/28/2018 |
| Start Date: | September 2014 |
| End Date: | April 2015 |
Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
The purpose of this study is to assess the serologic and cell-mediated immune response to
licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in
children 5-17 years old. The effects of prior infection and or prior season vaccination will
be examined. Children will be followed during the influenza season to identify
laboratory-confirmed influenza (i.e. vaccine failure).
licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in
children 5-17 years old. The effects of prior infection and or prior season vaccination will
be examined. Children will be followed during the influenza season to identify
laboratory-confirmed influenza (i.e. vaccine failure).
All children will have baseline blood samples drawn and will then be vaccinated with licensed
and approved influenza vaccines. Following the recommendation from the Advisory Committee on
Immunization Practices, children 5-8 years old will preferentially receive live attenuated
influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or
inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed
influenza vaccine will be excluded from the study.
The children will have their blood drawn between 2 and 4 times total over the course of two
months in order to test their immune response to the vaccine. Between approximately December
and April, study participants will be contacted weekly to monitor for any new respiratory
illnesses with cough, and if present, nasal and throat swabs will be collected to test for
influenza.
and approved influenza vaccines. Following the recommendation from the Advisory Committee on
Immunization Practices, children 5-8 years old will preferentially receive live attenuated
influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or
inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed
influenza vaccine will be excluded from the study.
The children will have their blood drawn between 2 and 4 times total over the course of two
months in order to test their immune response to the vaccine. Between approximately December
and April, study participants will be contacted weekly to monitor for any new respiratory
illnesses with cough, and if present, nasal and throat swabs will be collected to test for
influenza.
Inclusion Criteria:
- Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)
- Enrolled in either the immune response study or the vaccine effectiveness study
conducted at the site in the 2013-14 influenza season
- If enrolled in the vaccine effectiveness study the previous season must have either
been vaccinated and infected with influenza or unvaccinated and uninfected with
influenza
Exclusion Criteria:
- Children with contraindications to either the quadrivalent live attenuated influenza
vaccine or to the trivalent inactivated influenza vaccine will be excluded.
- Anyone unwilling or unable to complete all required study activities including
informed consent
- Subjects who already received the influenza vaccine for the 2014-15 season
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Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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