Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01421121
First received: July 22, 2011
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Infection, Viral, Enterovirus
Biological: 100U EV71 vaccine with adjuvant
Biological: 200 U EV71 vaccine with adjuvant
Biological: 400U EV71 vaccine with adjuvant
Biological: 200U EV71 vaccine without adjuvant
Biological: Placebo
Phase 2

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

Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • Neutralization antibody geometric mean titer in infants 28 days after immunization with EV71 vaccine with or without aluminium hydroxide adjuvant [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus >= 1:8


Secondary Outcome Measures:
  • The rates and severity of solicited adverse events in infants following immunization as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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



Enrollment: 540
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100U EV71 vaccine with adjuvant
120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
Biological: 100U EV71 vaccine with adjuvant
inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval
Other Name: EV71 vaccine
Experimental: 200 U EV71 vaccine with adjuvant
120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
Biological: 200 U EV71 vaccine with adjuvant
inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval
Other Name: EV71 vaccine
Experimental: 400U EV71 vaccine with adjuvant
120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart
Biological: 400U EV71 vaccine with adjuvant
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Other Name: EV71 vaccine
Experimental: 200U EV71 vaccine without adjuvant
60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart
Biological: 200U EV71 vaccine without adjuvant
inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval
Other Name: EV71 vaccine
Placebo Comparator: Placebo
120 infants received 2 doses of placebo 28 days apart.
Biological: Placebo
0.5ml placebo, two doses, 28 days interval
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421121

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

No publications provided

Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01421121     History of Changes
Other Study ID Numbers: EV71-1001-II
Study First Received: July 22, 2011
Last Updated: November 26, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Enterovirus Infections
Virus Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014