Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants

NCT ID: NCT01812135

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-12-31

Brief Summary

A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant

Conditions

Infection, Viral, Enterovirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1: 400U EV71 vaccine without adjuvant

60 infants received 2 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant 28 days apart

Group Type: EXPERIMENTAL

400 U EV71 vaccine with adjuvant

Intervention Type: BIOLOGICAL

400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

Group 2: 400U EV71 vaccine without adjuvant

60 infants received 1 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant

Group Type: EXPERIMENTAL

400 U EV71 vaccine with adjuvant

Intervention Type: BIOLOGICAL

400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

Group 3: 400U EV71 vaccine with adjuvant

60 infants received 1 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant

Group Type: EXPERIMENTAL

400 U EV71 vaccine with adjuvant

Intervention Type: BIOLOGICAL

400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

Interventions

400 U EV71 vaccine with adjuvant

400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

Intervention Type: BIOLOGICAL

Other Intervention Names

EV71 vaccine

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females, aged from 6 to 11 months 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: 11 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan-pin Li, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Centers for Disease Control and Prevention

Locations

GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Countries

China

Other Identifiers

EV71-1001-II-02

Identifier Type: -

Identifier Source: org_study_id