B-cell Immunity to Influenza (SLVP017)- Year 5, 2013

Status Completed

Clinical Trial Summary

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different vaccines given to identical twins and vaccine-naive young adults.

Clinical Trial Description

This is a study of healthy children and adults who will be given standard seasonal influenza vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review and confirmation of written informed consent, volunteers will be enrolled into the study.

The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization), Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline blood sample will be drawn prior to immunization at Day 0, followed by two additional blood samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample collected at Day 28-32.

The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013 seasonal influenza vaccine. Participants in Group B will receive a single dose of the 2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3 blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be drawn prior to immunization at Day 0. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03020537
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Phase 4
Start date	October 2013
Completion date	December 2013

View Details

See also
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