NCT02269852

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged \> 60 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

October 8, 2014

Last Update Submit

September 18, 2015

Conditions

Influenza

Keywords

seasonal trivalent inactivated influenza vaccineimmunogenicitysafetycross-reactivityNorthern hemisphere 2013-2014 formulation

Outcome Measures

Primary Outcomes (1)

  • The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors

    To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer

    21 days after vaccination

Secondary Outcomes (2)

  • The incidences of adverse events (AEs) in infants, adults and seniors

    Day 0 - day 35

  • The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus

    21 days after vaccination

Study Arms (1)

trivalent seasonal influenza vaccine

EXPERIMENTAL

Northern hemisphere 2013-2014 trivalent seasonal influenza vaccine * 60 infants: two-dose regimen with a 28-day interval; * 60 adults: single-dose regimen; * 60 seniors: single-dose regimen;

Biological: trivalent seasonal influenza vaccine

Interventions

trivalent seasonal influenza vaccineBIOLOGICAL

* Infants: 0.25 ml/ dose; * Adults: 0.5 ml/ dose; * Seniors: 0.5 ml/ dose;

Also known as: Anflu®
trivalent seasonal influenza vaccine

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged 18-60 years old, and healthy seniors aged \> 60 years old;
  • Without vaccination history of seasonal split influenza vaccine in the recent 3 years
  • No traveling plan during the study period of this trial;
  • Be able to understand and sign the informed consent;

You may not qualify if:

  • Allergic to egg products or any ingredient of the study vaccine;
  • Fever, influenza or acute illness on the vaccination day;
  • Acute stage of chronic illness;
  • Malignant tumor;
  • Immunodeficiency, includes HIV infection;
  • Guillain-Barre syndrome;
  • Administration of live attenuated vaccine within the previous 14 days;
  • Administration of subunit or inactivated vaccine within the previous 7 days;
  • Planned to participate in any other clinical trial of drug or vaccine during this study;
  • Received immunesuppressive treatment within the previous month, or planned for such treatment during this study;
  • Pregnant, or planning pregnancy;
  • Axillary temperature \> 37.0℃;
  • Any other factors that, in the judgment of the investigator, is unsuitable for this study;
  • For infants:
  • Healthy male or female aged between 6 and 35 months;
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guzhen Center for Diseases Control and Prevention

Bengbu, Anhui, China

Location

Related Publications (1)

  • Shen Y, Hu Y, Meng F, Du W, Li W, Song Y, Ji X, Huo L, Fu Z, Yin W. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu(R). Hum Vaccin Immunother. 2016 May 3;12(5):1229-34. doi: 10.1080/21645515.2015.1123357. Epub 2016 Mar 2.

    PMID: 26934750DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Yong-Gang Shen

    Anhui Center for Diseases Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 21, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations

CN(1)