Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

Phase 2

Completed

• Conditions: Infection, Viral, Enterovirus
• Interventions: Biological: 100U EV71 vaccine with adjuvant; Biological: 200 U EV71 vaccine with adjuvant; Biological: 400U EV71 vaccine with adjuvant; Biological: 200U EV71 vaccine without adjuvant; Biological: Placebo

• Registration Number: NCT01421121
• Lead Sponsor: Sinovac Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100U EV71 vaccine with adjuvant	100U EV71 vaccine with adjuvant	120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
200 U EV71 vaccine with adjuvant	200 U EV71 vaccine with adjuvant	120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
400U EV71 vaccine with adjuvant	400U EV71 vaccine with adjuvant	120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
200U EV71 vaccine without adjuvant	200U EV71 vaccine without adjuvant	60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart
Placebo	Placebo	120 infants received 2 doses of placebo 28 days apart.

Primary Outcome Measures

Name	Time	Method
Neutralization antibody geometric mean titer in infants 28 days after immunization with EV71 vaccine with or without aluminium hydroxide adjuvant	6 month	Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8

Secondary Outcome Measures

Name	Time	Method
The rates and severity of solicited adverse events in infants following immunization as a Measure of Safety and Tolerability	6 months	solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site.; solicited general adverse events include Fever, Nausea, Vomiting, Diareahhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

Trial Locations

Locations (1)

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