Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

Infection, Viral, Enterovirus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421121
• Other study ID #: EV71-1001-II
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2011
• Last updated: November 26, 2012
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection, Viral, Enterovirus
• Virus Diseases

Intervention

Biological:
• 100U EV71 vaccine with adjuvant
inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval
• 200 U EV71 vaccine with adjuvant
inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval
• 400U EV71 vaccine with adjuvant
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
• 200U EV71 vaccine without adjuvant
inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval
• Placebo
0.5ml placebo, two doses, 28 days interval

Locations

Country	Name	City	State
China	GuangXi Center for Diseases Control and Prevention	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes