Influenza, Human Clinical Trial
Official title:
Effect of Influenza Vaccination or Infection on the Development of Protective Immunity in Children
More information is needed on how children fight off influenza virus, as they are at greater risk for developing severe influenza infection and tend to have weaker responses to influenza vaccination. The purpose of this study is to understand how a child's early exposure to influenza vaccine or infection with influenza virus prepares him or her to combat future infections with this virus. Investigators will learn about how protection develops following an influenza infection or vaccination and the impact this has on future vaccine responses. The information learned may allow us to develop better vaccines against influenza virus in the future.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months to 15 Years |
Eligibility |
Inclusion Criteria: - Age - Between 6 and 12 months at the time of enrollment to participate in the vaccination arm of age cohort 1A - Between 3 and 12 months at the time of enrollment to participate in the natural infection arm of age cohort 1B - > 12 months, birth date after 2009 for either the vaccination (A) or natural infection (B) arm of age cohort 2 - Birth date between 2006 and 2009 for either the vaccination (A) or natural infection (B) arm of age cohort 3 - Birth date between 2003 and 2006 for the vaccination (A) or natural infection (B) arm of age cohort 4 - Gestational age of =37 weeks at birth - Parent/LAR can provide informed consent, with children =8 years of age providing informed assent - Available for the duration of the study - History of previous primary IIV vaccination (at least 2 previous doses for age <9 yrs, at least 1 previous dose for age 9 and older) ONLY for participation in the vaccination (A) arm of age cohorts 2, 3, or 4 - Acute illness documented by rapid influenza test, PCR testing, or testing done by either URMC Labs or RGH Clinical Microbiology Labs to be due to influenza virus ONLY for participation in the natural infection arms (B) of age cohorts 1-4. - Children enrolled in the Cohort A (vaccination cohort) are required to have an appropriate weight and vital signs as determined by a licensed medical provider. Children enrolled in the Cohort B (natural infection cohort) are required to have an appropriate weight and clinically stable vital signs as determined by a licensed medical provider. - Children will not qualify for study participation if their weight is more than 2.5 standard deviations below population norms. This will be determined through calculation of a Z score using the PediTools website (https://www.peditools.org/) utilizing the appropriate CDC growth calculators for age Exclusion Criteria: - Immunosuppression as a result of an underlying illness or condition (including HIV or a primary immunodeficiency syndrome) - Active neoplastic disease - Use of potentially immunosuppressive medications currently or within the past year (including chemotherapeutic agents) or chronic (>2 weeks) use of oral or inhaled steroid therapy - A diagnosis of asthma requiring chronic controller medication - Participation in any clinical research study evaluating an investigational drug or therapy that is inconsistent with current standard of care within two (2) months of enrollment in this study. - Previous administration of influenza vaccine in the current influenza season ONLY for subjects in the vaccination arm (A) of the study (subjects presenting with acute influenza infection with vaccine failure will be eligible to enroll in the B cohorts). - Receipt of immunoglobulin or another blood product within the year prior to study enrollment - An acute illness within the previous 3 days or temperature >38oC on screening EXCEPT for participation in the natural infection (B) cohorts - A contraindication to influenza vaccination EXCEPT infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age. - Anemia in the previous 6 months (children on iron supplementation with no documentation of abnormal hemoglobin and/or hematocrit for >6 months will be allowed to participate in the study) - Recent (within 120 days) hospitalization, excluding hospitalization for delivery or subjects enrolled in the acute cohort who have been hospitalized for influenza-related reasons - Any medical history or other condition that the study PI feels may have a more than a minimal impact on the immune response or may impact the safety of the subject. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to day 10 and day 24 in CD4 T cell responses | CD4 T cell quantity and specificity will be measured using intracellular cytokine staining | Baseline to Day 10 and day 24 post vaccination | |
Secondary | Change from baseline to day 24 in antibody titers | Amount of post-vaccination antibody will be measured by ELISA assay | Baseline and day 24 post-vaccination |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Completed |
NCT03275389 -
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
|
Phase 1 | |
Completed |
NCT05981846 -
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
|
Phase 2 | |
Completed |
NCT05044195 -
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
|
Phase 3 | |
Completed |
NCT02914275 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
|
Phase 3 | |
Completed |
NCT04590066 -
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
|
N/A | |
Completed |
NCT04527614 -
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
|
N/A | |
Terminated |
NCT03658629 -
Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
|
Phase 2 | |
Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
Withdrawn |
NCT02883972 -
Childhood Influenza Immunisation Invitation Trial in Schools
|
N/A | |
Completed |
NCT02998996 -
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
|
Phase 1/Phase 2 | |
Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
Completed |
NCT02867358 -
A Clinical Trial of KT07 Capsule in the U.S.A
|
Phase 2 | |
Completed |
NCT02545543 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
|
Phase 3 | |
Completed |
NCT02243774 -
Mail Outreach To Increase Vaccination Acceptance Through Engagement
|
N/A | |
Completed |
NCT02212106 -
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
|
Phase 4 | |
Completed |
NCT02621164 -
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
|
Phase 3 | |
Completed |
NCT02344134 -
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
|
Phase 3 | |
Completed |
NCT01674205 -
Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines
|
Phase 1 |