NCT04133584

Brief Summary

The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,134

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2019

Typical duration 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

September 16, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

September 18, 2019

Last Update Submit

July 12, 2022

Conditions

Seasonal InfluenzaHand, Foot and Mouth Disease

Keywords

ImmunogenicitySafetyEnterovirus 71 Vaccineseasonal influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • immunogenicity evaluation

    The positive rate of antibody

    change from baseline antibody concentration at 28 days after the last dose

Secondary Outcomes (1)

  • safety evaluation: The occurrence of adverse events

    up to 30 days after every injection

Study Arms (3)

Group 1 EV71 +SIV

EXPERIMENTAL

Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Biological: EV71 +SIV

Group 2 EV71

ACTIVE COMPARATOR

Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart

Biological: EV71

Group 3 SIV

ACTIVE COMPARATOR

Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Biological: SIV

Interventions

EV71 +SIVBIOLOGICAL

Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.

Group 1 EV71 +SIV
EV71BIOLOGICAL

Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last

Group 2 EV71
SIVBIOLOGICAL

Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

Group 3 SIV

Eligibility Criteria

Age6 Months - 11 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
  • Participant is aged ≥ 6 month to \<12 months.
  • Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Body temperature ≤ 37.0#.

You may not qualify if:

  • Known allergy to any constituent of the vaccine.
  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
  • Known bleeding disorder.
  • Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
  • Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
  • An acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial.
  • Participation in any other intervention clinical trial.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liandu Center for Disease Control and Prevention

Lishui, Zhejiang, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

October 21, 2019

Study Start

September 16, 2019

Primary Completion

June 30, 2021

Study Completion

November 30, 2021

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)