Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

Phase 1

Completed

• Conditions: Hand-foot-mouth Disease; Infection; Viral, Enterovirus
• Interventions: Biological: 200U inactivated Enterovirus Type 71 Vaccine; Biological: Placebo; Biological: 400U inactivated Enterovirus Type 71 Vaccine; Biological: 100U inactivated Enterovirus Type 71 Vaccine

• Registration Number: NCT01273246
• Lead Sponsor: Sinovac Biotech Co., Ltd

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).

Detailed Description

36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2011-06
• Status Verified: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2021-07-25
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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. Histroy 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants Group 2: 200U EV71 vaccine	200U inactivated Enterovirus Type 71 Vaccine	24 infants received 3 doses of 200U EV71 vaccine 28 days apart
Infants Group 2: Placebo	Placebo	8 infants received 3 doses of placebo 28 days apart
Children Group 2: 400U EV71 vaccine	400U inactivated Enterovirus Type 71 Vaccine	12 children received 3 doses of 400U EV71 vaccine 28 days apart
Infants Group 3: Placebo	Placebo	8 infants received 3 doses of placebo 28 days apart
Children Group 1: 200U EV71 vaccine	200U inactivated Enterovirus Type 71 Vaccine	12 children received 3 doses of 200U EV71 vaccine 28 days apart
Infants Group 1: Placebo	Placebo	8 infants received 3 doses of placebo 28 days apart
Infants Group 3: 400U EV71 vaccine	400U inactivated Enterovirus Type 71 Vaccine	24 infants received 3 doses of 400U EV71 vaccine 28 days apart
Children Group 2: Placebo	Placebo	6 children received 3 doses of placebo 28 days apart
Infants Group 1: 100U EV71 vaccine	100U inactivated Enterovirus Type 71 Vaccine	24 infants received 3 doses of 100U EV71 vaccine 28 days apart
Children Group 1: Placebo	Placebo	6 children received 3 doses of placebo 28 days apart

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine	6 months	All adverse events were records. Blood cell and biochemistry were performed.

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine	6 months	virus neutralization assays were performed.

Trial Locations

Locations (1)

GuangXi Center for Diseases Control and Prevention; 🇨🇳 Nanning, Guangxi, China