- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01273246
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
July 25, 2021 updated by: Sinovac Biotech Co., Ltd
A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
Study Overview
Status
Completed
Detailed Description
36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China
- GuangXi Center for Diseases Control and Prevention
-
-
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 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
- Provided legal identification for the sake of recruitment.
- Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
- Birth weight more than 2500 grams
Exclusion Criteria:
- Histroy of Hand-foot-mouth Disease
- Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
- Epilepsy, seizures or convulsions history, or family history of mental illness
- Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
- History of asthma, angioedema, diabetes or malignancy
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
- Acute illness or acute exacerbation of chronic disease within the past 7 days
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- History of any blood products within 3 months
- Administration of any live attenuated vaccine within 28 days
- Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
- Axillary temperature > 37.0 centigrade before vaccination
- Abnormal laboratory parameters before vaccination
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Children Group 1: 200U EV71 vaccine
12 children received 3 doses of 200U EV71 vaccine 28 days apart
|
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose.
Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Names:
|
Placebo Comparator: Children Group 1: Placebo
6 children received 3 doses of placebo 28 days apart
|
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose.
Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
|
Experimental: Children Group 2: 400U EV71 vaccine
12 children received 3 doses of 400U EV71 vaccine 28 days apart
|
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose.
Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Names:
|
Placebo Comparator: Children Group 2: Placebo
6 children received 3 doses of placebo 28 days apart
|
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose.
Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
|
Experimental: Infants Group 1: 100U EV71 vaccine
24 infants received 3 doses of 100U EV71 vaccine 28 days apart
|
Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose.
Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Names:
|
Placebo Comparator: Infants Group 1: Placebo
8 infants received 3 doses of placebo 28 days apart
|
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose.
Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
|
Experimental: Infants Group 2: 200U EV71 vaccine
24 infants received 3 doses of 200U EV71 vaccine 28 days apart
|
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose.
Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Names:
|
Placebo Comparator: Infants Group 2: Placebo
8 infants received 3 doses of placebo 28 days apart
|
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose.
Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
|
Experimental: Infants Group 3: 400U EV71 vaccine
24 infants received 3 doses of 400U EV71 vaccine 28 days apart
|
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose.
Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Other Names:
|
Placebo Comparator: Infants Group 3: Placebo
8 infants received 3 doses of placebo 28 days apart
|
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose.
Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
Time Frame: 6 months
|
All adverse events were records.
Blood cell and biochemistry were performed.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
Time Frame: 6 months
|
virus neutralization assays were performed.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yan-pin Li, MD, Guangxi Centers for Disease Control and Prevention
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013.
- Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.
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
January 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
January 7, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 25, 2021
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV71-1001-Ib
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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