Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

• ClinicalTrials.gov Identifier: NCT01273246
• Recruitment Status: Completed
• First Posted: January 10, 2011
• Last Update Posted: July 25, 2011
• Sponsor: Sinovac Biotech Co., Ltd
• Information provided by: Sinovac Biotech Co., Ltd

Study Description

Brief Summary:

A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).

Condition or disease	Intervention/treatment	Phase
Hand-foot-mouth Disease; Infection; Viral, Enterovirus	Biological: 100U inactivated Enterovirus Type 71 Vaccine; Biological: 200U inactivated Enterovirus Type 71 Vaccine; Biological: 400U inactivated Enterovirus Type 71 Vaccine; Biological: Placebo	Phase 1

Detailed Description:

36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
• Study Start Date: January 2011
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Children Group 1: 200U EV71 vaccine; 12 children received 3 doses of 200U EV71 vaccine 28 days apart	Biological: 200U inactivated Enterovirus Type 71 Vaccine; Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Other Name: EV71 vaccine
Placebo Comparator: Children Group 1: Placebo; 6 children received 3 doses of placebo 28 days apart	Biological: Placebo; Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Experimental: Children Group 2: 400U EV71 vaccine; 12 children received 3 doses of 400U EV71 vaccine 28 days apart	Biological: 400U inactivated Enterovirus Type 71 Vaccine; Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Other Name: EV71 vaccine
Placebo Comparator: Children Group 2: Placebo; 6 children received 3 doses of placebo 28 days apart	Biological: Placebo; Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Experimental: Infants Group 1: 100U EV71 vaccine; 24 infants received 3 doses of 100U EV71 vaccine 28 days apart	Biological: 100U inactivated Enterovirus Type 71 Vaccine; Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Other Name: EV71 vaccine
Placebo Comparator: Infants Group 1: Placebo; 8 infants received 3 doses of placebo 28 days apart	Biological: Placebo; Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Experimental: Infants Group 2: 200U EV71 vaccine; 24 infants received 3 doses of 200U EV71 vaccine 28 days apart	Biological: 200U inactivated Enterovirus Type 71 Vaccine; Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Other Name: EV71 vaccine
Placebo Comparator: Infants Group 2: Placebo; 8 infants received 3 doses of placebo 28 days apart	Biological: Placebo; Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
Experimental: Infants Group 3: 400U EV71 vaccine; 24 infants received 3 doses of 400U EV71 vaccine 28 days apart	Biological: 400U inactivated Enterovirus Type 71 Vaccine; Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm; Other Name: EV71 vaccine
Placebo Comparator: Infants Group 3: Placebo; 8 infants received 3 doses of placebo 28 days apart	Biological: Placebo; Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm

Outcome Measures

Primary Outcome Measures :

1. To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ]
   All adverse events were records. Blood cell and biochemistry were performed.

Secondary Outcome Measures :

1. To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine [ Time Frame: 6 months ]
   virus neutralization assays were performed.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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. Histroy 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

Contacts and Locations

Locations

China, Guangxi

GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Sponsors and Collaborators

Sinovac Biotech Co., Ltd

Investigators

• Principal Investigator: Yan-pin Li, MD; Guangxi Centers for Disease Control and Prevention

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013.

Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.

• Responsible Party: Wei-Dong Yin, Sinovac Biotech Co., Ltd
• ClinicalTrials.gov Identifier: NCT01273246
• Other Study ID Numbers: EV71-1001-Ib
• First Posted: January 10, 2011
• Last Update Posted: July 25, 2011
• Last Verified: July 2011

Additional relevant MeSH terms:

Enterovirus Infections; Hand, Foot and Mouth Disease; Virus Diseases; Mouth Diseases; Picornaviridae Infections; RNA Virus Infections; Stomatognathic Diseases; Coxsackievirus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs