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Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

Primary Purpose

Hand, Foot and Mouth Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
three consecutive lots of EV71 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 and Mouth Disease focused on measuring 71 vaccine, HFMD, consistency of three consecutive lots, immunogenicity

Eligibility Criteria

6 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

  • History 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 14 days
  • Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 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

Sites / Locations

  • Jurong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lot 1

Lot 2

Lot 3

Placebo

Arm Description

inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28

inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28

inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28

Placebo in 350 infants aged 6 months to 5 years old on day 0,28

Outcomes

Primary Outcome Measures

The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination

Secondary Outcome Measures

Frequency of systemic and local adverse reactions after the first vaccination
Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
Frequency of systemic and local adverse reactions after the second vaccination
Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine

Full Information

First Posted
July 5, 2012
Last Updated
March 13, 2013
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01636245
Brief Title
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine
Official Title
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
February 2013 (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
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
Detailed Description
The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease
Keywords
71 vaccine, HFMD, consistency of three consecutive lots, immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lot 1
Arm Type
Experimental
Arm Description
inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
Arm Title
Lot 2
Arm Type
Experimental
Arm Description
inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
Arm Title
Lot 3
Arm Type
Experimental
Arm Description
inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in 350 infants aged 6 months to 5 years old on day 0,28
Intervention Type
Biological
Intervention Name(s)
three consecutive lots of EV71 vaccine
Other Intervention Name(s)
Vaccine groups
Intervention Description
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Intervention Type
Biological
Intervention Name(s)
placebo
Other Intervention Name(s)
Control group
Intervention Description
placebo, two doses, 28 days interval
Primary Outcome Measure Information:
Title
The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
Description
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
Time Frame
28 days after first vaccination
Secondary Outcome Measure Information:
Title
Frequency of systemic and local adverse reactions after the first vaccination
Description
Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
Time Frame
28 days after the first vaccination
Title
Frequency of systemic and local adverse reactions after the second vaccination
Description
Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine
Time Frame
28 days after the second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 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 Exclusion Criteria: History 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 14 days Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 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
Yue-Mei Hu, BS
Organizational Affiliation
Jiangsu Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jurong
City
ZhenJiang
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24964084
Citation
Zhang H, An D, Liu W, Mao Q, Jin J, Xu L, Sun S, Jiang L, Li X, Shao J, Ma H, Huang X, Guo S, Chen H, Cheng T, Yang L, Su W, Kong W, Liang Z, Jiang C. Analysis of cross-reactive neutralizing antibodies in human HFMD serum with an EV71 pseudovirus-based assay. PLoS One. 2014 Jun 25;9(6):e100545. doi: 10.1371/journal.pone.0100545. eCollection 2014.
Results Reference
derived
PubMed Identifier
24108780
Citation
Hu YM, Wang X, Wang JZ, Wang L, Zhang YJ, Chang L, Liang ZL, Xia JL, Dai QG, Hu YL, Mao QY, Zhu FC, Song YF, Gao F, Chen JT. Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months. Clin Vaccine Immunol. 2013 Dec;20(12):1805-11. doi: 10.1128/CVI.00491-13. Epub 2013 Oct 9.
Results Reference
derived

Learn more about this trial

Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

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