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

A Double-blind and Randomized, Phase II -02 Study With Inactivated EV71 Vaccines in Healthy Infants

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

Study Overview

• Status: Withdrawn
• Conditions: Infection, Viral, Enterovirus
• Intervention / Treatment: Biological: 400 U EV71 vaccine with adjuvant

• Study Type: Interventional
• 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 11 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: 400U EV71 vaccine without adjuvant; 60 infants received 2 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant 28 days apart	Biological: 400 U EV71 vaccine with adjuvant; 400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant; Other Names: EV71 vaccine
Experimental: Group 2: 400U EV71 vaccine without adjuvant; 60 infants received 1 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant	Biological: 400 U EV71 vaccine with adjuvant; 400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant; Other Names: EV71 vaccine
Experimental: Group 3: 400U EV71 vaccine with adjuvant; 60 infants received 1 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant	Biological: 400 U EV71 vaccine with adjuvant; 400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant; Other Names: EV71 vaccine

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 400U vaccine with or without aluminium hydroxide adjuvant	Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus >= 1:8	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The rates and severity of solicited and unsolicited adverse events in infants following immunization as a Measure of Safety and Tolerability	2 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: September 1, 2011
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 15, 2013

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: March 1, 2013

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-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No