NCT01508247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,245

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

January 4, 2012

Last Update Submit

March 27, 2013

Conditions

Hand, Foot and Mouth DiseaseHerpanginaOther EV71-associated Diseases

Keywords

efficacysafetyinactivated vaccine (Vero Cell) against EV71EV71-associated diseases

Outcome Measures

Primary Outcomes (1)

  • the incidence density of the EV71-associated diseases in the vaccine group and placebo group.

    compare the incidence density of the EV71-associated diseases between the vaccine group and placebo group in Chinese children aged 6-35 months.

    begin at day 56 up to 14 months

Secondary Outcomes (11)

  • the frequency of all the adverse events in vaccine group and placebo group.

    up to 14 months

  • Seropositive rate of the vaccine group

    8 months after first vaccination

  • Seroconversion rate of the vaccine group

    8 months after first vaccination

  • GMT of the vaccine group

    8 months after first vaccination

  • Seropositive rate of the vaccine group

    14 months after first vaccination

  • +6 more secondary outcomes

Study Arms (2)

vaccine against EV71

EXPERIMENTAL

Inactivated vaccine (Vero Cell) against EV71 of 320U /0.5ml in 5000 children aged 6-35 months on day0, 28

Biological: inactivated vaccine (Vero Cell) against EV71

placebo

PLACEBO COMPARATOR

0/0.5ml placebo in 5000 children aged 6-35 months on day0, 28

Biological: 0/0.5ml placebo

Interventions

inactivated vaccine (Vero Cell) against EV71BIOLOGICAL

inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28

vaccine against EV71
0/0.5ml placeboBIOLOGICAL

0/0.5ml placebo, two doses, on day0, 28

placebo

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Donghai County Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Location

Pizhou County-Level City Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Location

Baoying County Center for Disease Control and Prevention

Yangzhou, Jiangsu, China

Location

Chaoyang Distinct Center for Disease Control and Prevention

Beijing, China

Location

Related Publications (3)

  • Zhu W, Jin P, Li JX, Zhu FC, Liu P. Correlates of protection for inactivated enterovirus 71 vaccine: the analysis of immunological surrogate endpoints. Expert Rev Vaccines. 2017 Sep;16(9):945-949. doi: 10.1080/14760584.2017.1335603. Epub 2017 Jun 12.

    PMID: 28548626DERIVED

  • Wei M, Meng F, Wang S, Li J, Zhang Y, Mao Q, Hu Y, Liu P, Shi N, Tao H, Chu K, Wang Y, Liang Z, Li X, Zhu F. 2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study. J Infect Dis. 2017 Jan 1;215(1):56-63. doi: 10.1093/infdis/jiw502. Epub 2016 Oct 17.

    PMID: 28077584DERIVED

  • Zhu FC, Meng FY, Li JX, Li XL, Mao QY, Tao H, Zhang YT, Yao X, Chu K, Chen QH, Hu YM, Wu X, Liu P, Zhu LY, Gao F, Jin H, Chen YJ, Dong YY, Liang YC, Shi NM, Ge HM, Liu L, Chen SG, Ai X, Zhang ZY, Ji YG, Luo FJ, Chen XQ, Zhang Y, Zhu LW, Liang ZL, Shen XL. Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2013 Jun 8;381(9882):2024-32. doi: 10.1016/S0140-6736(13)61049-1. Epub 2013 May 29.

    PMID: 23726161DERIVED

MeSH Terms

Conditions

Hand, Foot and Mouth DiseaseHerpangina

Interventions

Vaccines, Inactivated

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsEchovirus Infections

Intervention Hierarchy (Ancestors)

VaccinesBiological ProductsComplex Mixtures

Study Officials

  • Feng-Cai Zhu, Master

    Jiangsu Provincial Center for Diseases Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

CN(4)