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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 M

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 Summary:
Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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.


Information By: Jiangsu Province Centers for Disease Control and Prevention

Dates:
Date Received: January 4, 2012
Date Started: January 2012
Date Completion:
Last Updated: March 27, 2013
Last Verified: March 2013