Influenza Clinical Trial
Official title:
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 Formulation)
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent
vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata
(6 months to < 36 months and 3 years to < 9 years)
Primary Objective:
- To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine,
administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on
Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of
age.
Observational Objectives:
- To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent
vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP
recommendations, in children 6 months to < 9 years of age.
- To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER)
for further analysis by the World Health Organization (WHO), the Centers for Disease
Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support
formulation recommendations for subsequent influenza vaccines.
Participants will be assigned to the appropriate age group (6 months to < 36 months of age
or 3 years to < 9 years of age) based on the subject's age at the time of enrollment.
Solicited adverse event (AE) information will be collected for 7 days after each
vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to
Visit 3 for those subjects receiving 2 doses. Serious adverse event information will be
collected from Visit 1 to Visit 2, or Visit 3 for those subjects receiving 2 doses.
Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and
at Day 28 after the final vaccination using the hemagglutination inhibition technique. For
each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be
calculated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
| Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
| Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
| Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
| Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
| Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
| Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
| Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
| Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
| Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
| Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
| Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
| Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |