A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
A Phase Ib Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
1 other identifier
interventional
360
1 country
1
Brief Summary
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community. Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from 13 to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences for the EV71 vaccine immunogenicity and the probable immunizing dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2011
Shorter than P25 for phase_1
1 active site
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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJanuary 2, 2012
March 1, 2011
3 months
March 10, 2011
December 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events after first vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after first vaccination
28 days after the first vaccination
Number of participants with adverse events after second vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after second vaccination
28 days after the second vaccination
Secondary Outcomes (4)
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
28 days after the first vaccination
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
28 days after second vaccination
The abnormity change of liver and kidney function indexes in serum after first vaccination in children
3 days after first vaccination
The abnormity change of liver and kidney function indexes in serum after second vaccination in children
3 days after second vaccination
Study Arms (8)
160U /0.5ml in children
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 children aged 13-60 months old on day0,28
320U /0.5ml in children
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 children aged 13-60 months old on day0,28
640U /0.5ml in children
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 children aged 13-60 months old on day0,28
160U /0.5ml in infants
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 infants aged 6-12 months old on day0,28
320U /0.5ml in infants
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 infants aged 6-12 months old on day0,28
640U /0.5ml in infants
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 infants aged 6-12 months old on day0,28
0/0.5ml placebo in children
PLACEBO COMPARATOR0/0.5ml placebo in 45 children aged 13-60 months old on day0,28
0/0.5ml placebo in infants
PLACEBO COMPARATOR0/0.5ml placebo in 45 infants aged 6-12 months old on day0,28
Interventions
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml, two doses, one month interval
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, one month interval
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml, two doses, one month interval
0/0.5ml placebo, two doses, one month interval
Eligibility Criteria
You may qualify if:
- Healthy subjects aged from 13 to 60 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature \<37.1°C on axillary setting
You may not qualify if:
- Subject who has a medical history of HFMD
- \<= 37 weeks gestation
- Subjects with a birth weight \<2.5 kg
- 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 dysgenopathy
- 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
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1month
- Any prior administration of attenuated live vaccine in last 28 days
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Donghai Center for Diseases Control and Prevention
Lianyungang, Jiangsu, 222300, China
Related Publications (1)
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.
PMID: 24260259DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Master
Jiangsu Provincial Center for Diseases Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
March 10, 2011
First Posted
March 14, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 2, 2012
Record last verified: 2011-03