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Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

NCT ID: NCT01421121

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infection, Viral, Enterovirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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100U EV71 vaccine with adjuvant

120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart

Group Type EXPERIMENTAL

100U EV71 vaccine with adjuvant

Intervention Type BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval

200 U EV71 vaccine with adjuvant

120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart

Group Type EXPERIMENTAL

200 U EV71 vaccine with adjuvant

Intervention Type BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval

400U EV71 vaccine with adjuvant

120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart

Group Type EXPERIMENTAL

400U EV71 vaccine with adjuvant

Intervention Type BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

200U EV71 vaccine without adjuvant

60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart

Group Type EXPERIMENTAL

200U EV71 vaccine without adjuvant

Intervention Type BIOLOGICAL

inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval

Placebo

120 infants received 2 doses of placebo 28 days apart.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

0.5ml placebo, two doses, 28 days interval

Interventions

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100U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval

Intervention Type BIOLOGICAL

200 U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval

Intervention Type BIOLOGICAL

400U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

Intervention Type BIOLOGICAL

200U EV71 vaccine without adjuvant

inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval

Intervention Type BIOLOGICAL

Placebo

0.5ml placebo, two doses, 28 days interval

Intervention Type BIOLOGICAL

Other Intervention Names

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EV71 vaccine EV71 vaccine EV71 vaccine EV71 vaccine

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Provided legal identification for the sake of recruitment.
3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
4. Birth weight more than 2500 grams

Exclusion Criteria

1. History of Hand-foot-mouth Disease
2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
5. Epilepsy, seizures or convulsions history, or family history of mental illness
6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
7. History of asthma, angioedema, diabetes or malignancy
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. 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
10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
11. Acute illness or acute exacerbation of chronic disease within the past 7 days
12. 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)
13. History of any blood products within 3 months
14. Administration of any live attenuated vaccine within 28 days
15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
16. Axillary temperature \> 37.0 centigrade before vaccination
17. Abnormal laboratory parameters before vaccination
18. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan-pin Li, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Centers for Disease Control and Prevention

Locations

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GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Site Status

Countries

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China

Other Identifiers

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EV71-1001-II

Identifier Type: -

Identifier Source: org_study_id