Phase 4 N=131 Randomized Basic Science

Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

Immune Response to Influenza Vaccine · Influenza A Virus Infection · Influenza B Virus Infection

Bottom Line

View on ClinicalTrials.gov: NCT02250274 ↗

Enrolled (actual)

131

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza — 99; 295; 96; 100 Titers

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: LAIV (Biological); IIV (Biological)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Marshfield Clinic Research Foundation
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza	99; 295; 96; 100	—
SECONDARY Polymerase Chain Reaction (PCR) Confirmed Influenza Illness	13; 5	—
SECONDARY Antibody Dependent Cellular Cytotoxicity (ADCC) Titers	1.02; 0.99; 1.47; 0.86; 1.31; 1.08	—
SECONDARY Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)	—	—

Summary

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02250274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.