Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months

September 6, 2016 updated by: Beijing Chaoyang District Centre for Disease Control and Prevention
This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20900

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 8 Months to 71 Months (Healthy Children or Infants)；
  • Providing the subjects' legal identity certificate (birth certificate , residence booklet or ID card) and vaccination certificate, legal guardians can provide legal identity proof (resident booklet or ID card) so that the doctor can determine the subject identity to complete recruitment program；
  • The subjects' guardians are able to understand and sign the informed consent voluntary. Guardians have the ability to use the thermometer ,dividing ruler and can fill out the Diary card ,follow-up card according to requirements；
  • Persist for a 24 months visit.If doubtful HFMD case happen，the subject's guardian should send the subject to the medical institutions at above the county level and report this case to the investigator.The subjects who participate immunogenicity observation group can receive sample collection including blood，throat swab or anal awab according to program requirements.

Exclusion Criteria:

  • Exclusion Criteria for the first dose:

    • Subject with clinical diagnosis or suspect HFMD（Especially the history of herpangina）；
    • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine；
    • History of seizures,convulsions or twitching ;Family history of progressive neurological disease；
    • Autoimmune disease or immunologic deficiency.Any prior administration of immunodepressant in last 6month；
    • History of asthma，thyroid ablation，angioneurotic edema, diabetes mellitus or malignant tumour；
    • Alienia，functional asplenia，or any condition that cause asplenia or splenectomy；
    • Diagnosed coagulation abnormalities (such as clotting factor deficiency, coagulation disorders, platelet disorder) or significant bruising or blood clotting disorder；
    • Any acute disease or chronic disease attack in last 7 days；
    • Any prior administration of blood products in last 3 month；
    • Any prior administration of attenuated live vaccine in last 15 days , subunit or inactivated vaccines in last 7 days；
    • Fever before vaccination, axillary temperature ﹥37.0℃；
    • Attend Other vaccine or drug clinical trials concurrent in 6 months；
    • Any condition that in the opinion of the investigator。

  • Exclusion Criteria for the second dose:

    • Any exclusion criteria for the first dose happens after been enrolled；
    • Newly HFMD diagnosed patients after been enrolled；
    • Any condition that in the opinion of the investigator or ethics committee think should be eliminated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 300 subjects receive the first batch vaccine
300 subjects will be randomly received the first batch vaccine
Biological: the first batch vaccine
EXPERIMENTAL: 300 subjects receive the second batch vaccine
300 subjects will be randomly received the second batch vaccine
Biological: the second batch vaccine
EXPERIMENTAL: 300 subjects receive the third batch vaccine
300 subjects will be randomly received the third batch vaccine
Biological: the third batch vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.
Time Frame: 24 months
Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.
24 months
Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.
Time Frame: 56 days
The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (ESTIMATE)

September 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cycdc2016-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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