A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age

Conditions

Influenza Vaccine Effectiveness

Keywords

Q/LAIV/FluMist® Quadrivalent Vaccine, Inactivated Influenza Vaccine (IIV), Effectiveness, Influenza

Brief summary

This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.

Detailed description

This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.

Katherine A. Poehling, Hervé Caspard, Timothy R. Peters, Edward A. Belongia, Blaise L. Congeni et al. (14 authors)

Clinical Infectious Diseases2017-10-0359 citations

10.1093/cid/cix869

Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children during the 2014–2015 season

Huong Q. McLean, Hervé Caspard, Marie R. Griffin, Katherine A. Poehling, Manjusha Gaglani et al. (10 authors)

Vaccine2017-04-1033 citations

10.1016/j.vaccine.2017.03.085

Association of vaccine handling conditions with effectiveness of live attenuated influenza vaccine against H1N1pdm09 viruses in the United States

Hervé Caspard, Kathleen Coelingh, Raburn M. Mallory, Christopher S. Ambrose

Vaccine2016-09-0142 citations

10.1016/j.vaccine.2016.08.079

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* Community-dwelling children and adolescents 2 to 17 years of age. * Written Informed Consent or Assent. * Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit) * Symptom onset less than 5 days prior to study visit. * Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.

Exclusion criteria

* Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment * Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results * Concurrent enrollment in another clinical study Patient already enrolled during this influenza season * Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

Design outcomes

Primary

Measure	Time frame	Description
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.	Up to 6 months for each individual flu season	Vaccine Effectiveness is defined as 100 x (1-odds ratio), where the odds ratio is the odds of exposures (Q/LAIV versus Inactivated Influenza Vaccine or no vaccine) among laboratory confirmed cases of flu versus controls. Effectiveness will be monitored by flu season, class of age and by influenza strain.

Countries

United Kingdom, United States

Outcome results