Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01636245
Other study ID # PRO-EV71-3002
Secondary ID
Status Completed
Phase Phase 3
First received July 5, 2012
Last updated March 13, 2013
Start date July 2012
Est. completion date February 2013

Study information

Verified date March 2013
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

The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.


Description:

The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.


Recruitment information / eligibility

Status Completed
Enrollment 1400
Est. completion date February 2013
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 5 Years
Eligibility Inclusion Criteria:

- 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

- Provided legal identification for the sake of recruitment

- Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents

Exclusion Criteria:

- History of Hand-foot-mouth Disease

- Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine

- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain

- Congenital malformations or developmental disorders, genetic defects, or severe malnutrition

- Epilepsy, seizures or convulsions history, or family history of mental illness

- Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency

- History of asthma, angioedema, diabetes or malignancy

- History of thyroidectomy or thyroid disease that required medication within the past 12 months

- 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

- Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen

- Acute illness or acute exacerbation of chronic disease within the past 7 days

- 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)

- History of any blood products within 3 months

- Administration of any live attenuated vaccine within 14 days

- Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 days

- Axillary temperature > 37.0 centigrade before vaccination

- Abnormal laboratory parameters before vaccination

- 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, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
three consecutive lots of EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
placebo
placebo, two doses, 28 days interval

Locations

Country Name City State
China Jurong ZhenJiang Jiangsu

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 The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination 28 days after first vaccination No
Secondary Frequency of systemic and local adverse reactions after the first vaccination Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine 28 days after the first vaccination Yes
Secondary Frequency of systemic and local adverse reactions after the second vaccination Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine 28 days after the second vaccination Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06063057 - Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial Phase 1/Phase 2
Completed NCT04133584 - The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine Phase 4
Completed NCT03241030 - Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial Phase 2
Completed NCT01255124 - Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children N/A
Completed NCT03873740 - Immunogenicity and Safety of Two Different Commercial EV71 Vaccines Phase 4
Completed NCT05637229 - A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
Recruiting NCT06146088 - Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine Phase 4
Active, not recruiting NCT06209398 - Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine Phase 4
Recruiting NCT01145664 - A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease N/A
Recruiting NCT01175915 - A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Completed NCT01182532 - A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Completed NCT03281174 - Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine N/A
Completed NCT03582761 - Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71 Phase 4
Completed NCT03903926 - Efficacy Trial of a Commercial EV71 Vaccine Phase 4
Completed NCT02001233 - A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Completed NCT03909074 - Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months Phase 3
Completed NCT01769794 - Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study N/A
Recruiting NCT01182025 - A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Recruiting NCT06263439 - Surveillance of HFMD in Pediatric Outpatients
Not yet recruiting NCT05397587 - An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell) Phase 4