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A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

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ClinicalTrials.gov Identifier: NCT01508247
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : March 29, 2013
Sponsor:
Collaborator:
Bejing Vigoo Biological Co., LTD
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 11, 2012
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
the incidence density of the EV71-associated diseases in the vaccine group and placebo group. [ Time Frame: begin at day 56 up to 14 months ]
compare the incidence density of the EV71-associated diseases between the vaccine group and placebo group in Chinese children aged 6-35 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • the frequency of all the adverse events in vaccine group and placebo group. [ Time Frame: up to 14 months ]
    compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.
  • Seropositive rate of the vaccine group [ Time Frame: 8 months after first vaccination ]
    calculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
  • Seroconversion rate of the vaccine group [ Time Frame: 8 months after first vaccination ]
    calculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
  • GMT of the vaccine group [ Time Frame: 8 months after first vaccination ]
    calculate the geometric mean titre (GMT) of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
  • Seropositive rate of the vaccine group [ Time Frame: 14 months after first vaccination ]
    calculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
  • Seroconversion rate of the vaccine group [ Time Frame: 14 months after first vaccination ]
    calculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
  • GMT of the vaccine group [ Time Frame: 14 months after first vaccination ]
    calculate the geometric mean titre (GMT) of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
  • Seropositive rate of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the seropositive rate of the vaccine group and placebo group in healthy children aged 6-35 months.
  • Seroconversion rate of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the Seroconversion rate of the vaccine group and placebo group in healthy children aged 6-35 months.
  • GMT of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the geometric mean titre (GMT) of the vaccine group and placebo group in healthy children aged 6-35 months.
  • GMI of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the geometric mean fold increase (GMFI) of the vaccine group and placebo group in healthy children aged 6-35 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • the frequency of all the adverse events in vaccine group and placebo group. [ Time Frame: up to 14 months ]
    compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.
  • Seropositive rate of the vaccine group [ Time Frame: 8 months after first vaccination ]
    caculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
  • Seroconversion rate of the vaccine group [ Time Frame: 8 months after first vaccination ]
    caculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
  • GMT of the vaccine group [ Time Frame: 8 months after first vaccination ]
    caculate the GMT of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.
  • Seropositive rate of the vaccine group [ Time Frame: 14 months after first vaccination ]
    caculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
  • Seroconversion rate of the vaccine group [ Time Frame: 14 months after first vaccination ]
    caculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
  • GMT of the vaccine group [ Time Frame: 14 months after first vaccination ]
    caculate the GMT of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.
  • Seropositive rate of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the seropositive rate of the vaccine group and placebo group in healthy children aged 6-35 months.
  • Seroconversion rate of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the Seroconversion rate of the vaccine group and placebo group in healthy children aged 6-35 months.
  • GMT of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the GMT of the vaccine group and placebo group in healthy children aged 6-35 months.
  • GMI of the vaccine group and placebo group [ Time Frame: 28 days after the second vaccination ]
    compare the GMI of the vaccine group and placebo group in healthy children aged 6-35 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months
Official Title  ICMJE A Multiple-center Randomized Double-blind Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months
Brief Summary

Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen associated with a severe from of brainstem encephalitis associated with pulmonary oedema and high case-fatality rates.

The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. According to the immunogenicity and safety results, the 320U with adjuvant with immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Hand, Foot and Mouth Disease
  • Herpangina
  • Other EV71-associated Diseases
Intervention  ICMJE
  • Biological: inactivated vaccine (Vero Cell) against EV71
    inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28
  • Biological: 0/0.5ml placebo
    0/0.5ml placebo, two doses, on day0, 28
Study Arms  ICMJE
  • Experimental: vaccine against EV71
    Inactivated vaccine (Vero Cell) against EV71 of 320U /0.5ml in 5000 children aged 6-35 months on day0, 28
    Intervention: Biological: inactivated vaccine (Vero Cell) against EV71
  • Placebo Comparator: placebo
    0/0.5ml placebo in 5000 children aged 6-35 months on day0, 28
    Intervention: Biological: 0/0.5ml placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2013)
10245
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2012)
10000
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Only subjects fulfilling all of the following criteria will be eligible for the study:

  • Healthy children aged from 6 to 35 months old
  • General good health as established by medical history and physical examination
  • The subjects' guardians are able to understand and sign the informed consent
  • Had never received the vaccine against EV71
  • The subjects' guardians allow to comply with the requirements of the protocol
  • Available for all visits scheduled in this study
  • Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

Subjects will not be eligible for the study if any of the following criteria is met:

  • Subject who has a medical history of HFMD
  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
  • Family history of seizures or progressive neurological disease
  • Family history of congenital or hereditary immunodeficiency
  • Severe malnutrition or hypogenesis
  • Major congenital defects or serious chronic illness, including perinatal brain damage
  • Autoimmune disease
  • Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
  • Asplenia, functional asplenia, or splenic excision
  • History of asthma, angioneurotic edema, diabetes or malignant tumour
  • History of thyroidectomy, or thyroid disease in last 12 months
  • Any acute infections in last 7 days
  • Any prior administration of immunodepressant or corticosteroids in last 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of other research vaccines or medicines in last 1 month
  • Any prior administration of attenuated live vaccine in last 15 days
  • Any prior administration of subunit or inactivated vaccines in last 7 days
  • Under the anti-TB prevention or therapy
  • Subjects with temperature >37.0°C on axillary setting
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Exclusion Criteria for the second dose:

Subjects will not be eligible for the second dose if any of following adverse events happened after the first dose. They can continue other process of the study without the second dose vaccination according to the opinion of the investigator.

  • Had any serious adverse events related to the first dose of inactivated vaccine (vero cell) against EV71 within 7 days
  • Hypersensitivity reactions after vaccination (including urticaria/rashes that occur within 30 minutes after inoculation)
  • Anaphylaxis after vaccination
  • Any confirmed or suspected autoimmune disease or immune deficiency diseases, including human immunodeficiency virus (HIV) infection
  • Any condition that in the opinion of the investigator, or IRB
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508247
Other Study ID Numbers  ICMJE JSVCT010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu Province Centers for Disease Control and Prevention
Study Sponsor  ICMJE Jiangsu Province Centers for Disease Control and Prevention
Collaborators  ICMJE Bejing Vigoo Biological Co., LTD
Investigators  ICMJE
Principal Investigator: Feng-Cai Zhu, Master Jiangsu Provincial Center for Diseases Control and Prevention
PRS Account Jiangsu Province Centers for Disease Control and Prevention
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP