NCT02401893

Brief Summary

Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI) antibodies after influenza vaccination in older adults so the investigators enrolled adults ≥50 years.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

March 9, 2015

Last Update Submit

March 27, 2015

Conditions

Keywords

aginginfluenza vaccineimmune responses

Outcome Measures

Primary Outcomes (1)

  • Maintenance of Immune Response using Hemagglutinin inhibition titers

    1 year

Interventions

Everyone immunized as recommended by current guidelines

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects were enrolled at Vanderbilt University Medical Center and Marshfield Clinic Research Foundation during September and October 2009. Subjects were eligible for recruitment if they were ≥50 years of age and had no previous allergy or reaction to influenza vaccination.

You may qualify if:

  • Age \>=50 years

You may not qualify if:

  • Prior vaccine allergy or history of guillain barre

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Talbot HK, Coleman LA, Zhu Y, Spencer S, Thompson M, Cheng PY, Sundaram ME, Belongia EA, Griffin MR. Factors associated with maintenance of antibody responses to influenza vaccine in older, community-dwelling adults. BMC Infect Dis. 2015 Apr 23;15:195. doi: 10.1186/s12879-015-0926-8.

Biospecimen

Retention: SAMPLES WITH DNA

serum samples were collected

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 30, 2015

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

January 1, 2014

Last Updated

March 30, 2015

Record last verified: 2015-03