NCT01310374

Brief Summary

An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

March 7, 2011

Last Update Submit

July 9, 2013

Conditions

Influenza Vaccine AllergyCell Mediated Reaction

Keywords

influenza vaccineimmune responsedynamic changes

Outcome Measures

Primary Outcomes (1)

  • the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine

    one year

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • aged 12-60 years old
  • male or non-pregnant female
  • volunteers
  • clinically healthy as determined by: medical history inquiring and physical examination
  • provide written informed consents before joining the trial

You may not qualify if:

  • infected with Influenza A virus subtype H1N1(2009),
  • vaccinated with seasonal influenza vaccine,
  • allergic to any ingredient of vaccine,
  • autoimmune disease or immunodeficiency,
  • active malignancy,
  • bleeding disorder,
  • seizure disorder,
  • Guillain-Barre Syndrome,
  • treatment with cytotoxic or immunosuppressive drugs within the past 6 months,
  • receipt of blood products within the past 3 months,
  • administration of any other investigational research agents or live attenuated vaccine within 30 days,
  • administration of subunit or inactivated vaccines within 14 days,
  • axillary temperature over 37.0℃ at the time of vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • jiang wu, Bachelor

    Beijing Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Centers for Disease Control and Prevention, China

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

December 1, 2012

Last Updated

July 10, 2013

Record last verified: 2013-07