Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

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.

Study Overview

• Status: Completed
• Conditions: Infection, Viral, Enterovirus
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China
      • GuangXi Center for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100U EV71 vaccine with adjuvant; 120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart	Biological: 100U EV71 vaccine with adjuvant; inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval; Other Names: EV71 vaccine
Experimental: 200 U EV71 vaccine with adjuvant; 120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart	Biological: 200 U EV71 vaccine with adjuvant; inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval; Other Names: EV71 vaccine
Experimental: 400U EV71 vaccine with adjuvant; 120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart	Biological: 400U EV71 vaccine with adjuvant; inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval; Other Names: EV71 vaccine
Experimental: 200U EV71 vaccine without adjuvant; 60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart	Biological: 200U EV71 vaccine without adjuvant; inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval; Other Names: EV71 vaccine
Placebo Comparator: Placebo; 120 infants received 2 doses of placebo 28 days apart.	Biological: Placebo; 0.5ml placebo, two doses, 28 days interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rates and severity of solicited adverse events in infants following immunization as a Measure of Safety and Tolerability	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	6 months

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Yan-pin Li, MD, Guangxi Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 22, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (Estimate): August 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: EV71-1001-II