Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants
1 other identifier
interventional
540
1 country
1
Brief Summary
A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Shorter than P25 for phase_2
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
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 27, 2012
November 1, 2012
3 months
July 22, 2011
November 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Neutralization antibody geometric mean titer in infants 28 days after immunization with EV71 vaccine with or without aluminium hydroxide adjuvant
Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8
6 month
Secondary Outcomes (1)
The rates and severity of solicited adverse events in infants following immunization as a Measure of Safety and Tolerability
6 months
Study Arms (5)
100U EV71 vaccine with adjuvant
EXPERIMENTAL120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
200 U EV71 vaccine with adjuvant
EXPERIMENTAL120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
400U EV71 vaccine with adjuvant
EXPERIMENTAL120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
200U EV71 vaccine without adjuvant
EXPERIMENTAL60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart
Placebo
PLACEBO COMPARATOR120 infants received 2 doses of placebo 28 days apart.
Interventions
inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval
inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval
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:
- History 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan-pin Li, MD
Guangxi Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
July 22, 2011
First Posted
August 22, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
November 27, 2012
Record last verified: 2012-11