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Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

Primary Purpose

Hand-foot-mouth Disease, Infection; Viral, Enterovirus

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
100U inactivated Enterovirus Type 71 Vaccine
200U inactivated Enterovirus Type 71 Vaccine
400U inactivated Enterovirus Type 71 Vaccine
Placebo
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand-foot-mouth Disease

Eligibility Criteria

6 Months - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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
  2. Provided legal identification for the sake of recruitment.
  3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
  4. Birth weight more than 2500 grams

Exclusion Criteria:

  1. Histroy of Hand-foot-mouth Disease
  2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
  3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
  5. Epilepsy, seizures or convulsions history, or family history of mental illness
  6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
  7. History of asthma, angioedema, diabetes or malignancy
  8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  9. 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
  10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
  11. Acute illness or acute exacerbation of chronic disease within the past 7 days
  12. 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)
  13. History of any blood products within 3 months
  14. Administration of any live attenuated vaccine within 28 days
  15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
  16. Axillary temperature > 37.0 centigrade before vaccination
  17. Abnormal laboratory parameters before vaccination
  18. 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

Sites / Locations

  • GuangXi Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Children Group 1: 200U EV71 vaccine

Children Group 1: Placebo

Children Group 2: 400U EV71 vaccine

Children Group 2: Placebo

Infants Group 1: 100U EV71 vaccine

Infants Group 1: Placebo

Infants Group 2: 200U EV71 vaccine

Infants Group 2: Placebo

Infants Group 3: 400U EV71 vaccine

Infants Group 3: Placebo

Arm Description

12 children received 3 doses of 200U EV71 vaccine 28 days apart

6 children received 3 doses of placebo 28 days apart

12 children received 3 doses of 400U EV71 vaccine 28 days apart

6 children received 3 doses of placebo 28 days apart

24 infants received 3 doses of 100U EV71 vaccine 28 days apart

8 infants received 3 doses of placebo 28 days apart

24 infants received 3 doses of 200U EV71 vaccine 28 days apart

8 infants received 3 doses of placebo 28 days apart

24 infants received 3 doses of 400U EV71 vaccine 28 days apart

8 infants received 3 doses of placebo 28 days apart

Outcomes

Primary Outcome Measures

To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
All adverse events were records. Blood cell and biochemistry were performed.

Secondary Outcome Measures

To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
virus neutralization assays were performed.

Full Information

First Posted
January 7, 2011
Last Updated
July 25, 2021
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01273246
Brief Title
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
Official Title
A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand-foot-mouth Disease, Infection; Viral, Enterovirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children Group 1: 200U EV71 vaccine
Arm Type
Experimental
Arm Description
12 children received 3 doses of 200U EV71 vaccine 28 days apart
Arm Title
Children Group 1: Placebo
Arm Type
Placebo Comparator
Arm Description
6 children received 3 doses of placebo 28 days apart
Arm Title
Children Group 2: 400U EV71 vaccine
Arm Type
Experimental
Arm Description
12 children received 3 doses of 400U EV71 vaccine 28 days apart
Arm Title
Children Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
6 children received 3 doses of placebo 28 days apart
Arm Title
Infants Group 1: 100U EV71 vaccine
Arm Type
Experimental
Arm Description
24 infants received 3 doses of 100U EV71 vaccine 28 days apart
Arm Title
Infants Group 1: Placebo
Arm Type
Placebo Comparator
Arm Description
8 infants received 3 doses of placebo 28 days apart
Arm Title
Infants Group 2: 200U EV71 vaccine
Arm Type
Experimental
Arm Description
24 infants received 3 doses of 200U EV71 vaccine 28 days apart
Arm Title
Infants Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
8 infants received 3 doses of placebo 28 days apart
Arm Title
Infants Group 3: 400U EV71 vaccine
Arm Type
Experimental
Arm Description
24 infants received 3 doses of 400U EV71 vaccine 28 days apart
Arm Title
Infants Group 3: Placebo
Arm Type
Placebo Comparator
Arm Description
8 infants received 3 doses of placebo 28 days apart
Intervention Type
Biological
Intervention Name(s)
100U inactivated Enterovirus Type 71 Vaccine
Other Intervention Name(s)
EV71 vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
200U inactivated Enterovirus Type 71 Vaccine
Other Intervention Name(s)
EV71 vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
400U inactivated Enterovirus Type 71 Vaccine
Other Intervention Name(s)
EV71 vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
Description
All adverse events were records. Blood cell and biochemistry were performed.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
Description
virus neutralization assays were performed.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan-pin Li, MD
Organizational Affiliation
Guangxi Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
GuangXi Center for Diseases Control and Prevention
City
Nanning
State/Province
Guangxi
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24260259
Citation
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.
Results Reference
derived
PubMed Identifier
22426327
Citation
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.
Results Reference
derived

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Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

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