Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
1 other identifier
interventional
132
1 country
1
Brief Summary
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 28, 2021
July 1, 2011
5 months
January 7, 2011
July 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
All adverse events were records. Blood cell and biochemistry were performed.
6 months
Secondary Outcomes (1)
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
6 months
Study Arms (10)
Children Group 1: 200U EV71 vaccine
EXPERIMENTAL12 children received 3 doses of 200U EV71 vaccine 28 days apart
Children Group 1: Placebo
PLACEBO COMPARATOR6 children received 3 doses of placebo 28 days apart
Children Group 2: 400U EV71 vaccine
EXPERIMENTAL12 children received 3 doses of 400U EV71 vaccine 28 days apart
Children Group 2: Placebo
PLACEBO COMPARATOR6 children received 3 doses of placebo 28 days apart
Infants Group 1: 100U EV71 vaccine
EXPERIMENTAL24 infants received 3 doses of 100U EV71 vaccine 28 days apart
Infants Group 1: Placebo
PLACEBO COMPARATOR8 infants received 3 doses of placebo 28 days apart
Infants Group 2: 200U EV71 vaccine
EXPERIMENTAL24 infants received 3 doses of 200U EV71 vaccine 28 days apart
Infants Group 2: Placebo
PLACEBO COMPARATOR8 infants received 3 doses of placebo 28 days apart
Infants Group 3: 400U EV71 vaccine
EXPERIMENTAL24 infants received 3 doses of 400U EV71 vaccine 28 days apart
Infants Group 3: Placebo
PLACEBO COMPARATOR8 infants received 3 doses of placebo 28 days apart
Interventions
Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Eligibility Criteria
You may qualify if:
- 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.
- Birth weight more than 2500 grams
You may not qualify if:
- Histroy 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 28 days
- Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Related Publications (2)
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: 24260259DERIVEDLi YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.
PMID: 22426327DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan-pin Li, MD
Guangxi Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
July 28, 2021
Record last verified: 2011-07