Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine

NCT01636245 | Completed Phase 3 DMC

• 1 other identifier: PRO-EV71-3002
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand, Foot and Mouth Disease

Keywords

71 vaccine; HFMD; consistency of three consecutive lots; immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Frequency of systemic and local adverse reactions after the first vaccination

  28 days after the first vaccination

• Frequency of systemic and local adverse reactions after the second vaccination

  28 days after the second vaccination

Study Arms (4)

Lot 1

EXPERIMENTAL

inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28

Biological: three consecutive lots of EV71 vaccine

Lot 2

EXPERIMENTAL

inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28

Biological: three consecutive lots of EV71 vaccine

Lot 3

EXPERIMENTAL

inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28

Biological: three consecutive lots of EV71 vaccine

Placebo

PLACEBO COMPARATOR

Placebo in 350 infants aged 6 months to 5 years old on day 0,28

Biological: placebo

Interventions

three consecutive lots of EV71 vaccine BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

Also known as: Vaccine groups

Lot 1; Lot 2; Lot 3

placebo BIOLOGICAL

placebo, two doses, 28 days interval

Also known as: Control group

Placebo

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Jurong

Zhenjiang, Jiangsu, China

Location

Related Publications (2)

• Zhang H, An D, Liu W, Mao Q, Jin J, Xu L, Sun S, Jiang L, Li X, Shao J, Ma H, Huang X, Guo S, Chen H, Cheng T, Yang L, Su W, Kong W, Liang Z, Jiang C. Analysis of cross-reactive neutralizing antibodies in human HFMD serum with an EV71 pseudovirus-based assay. PLoS One. 2014 Jun 25;9(6):e100545. doi: 10.1371/journal.pone.0100545. eCollection 2014.

  PMID: 24964084 DERIVED

• Hu YM, Wang X, Wang JZ, Wang L, Zhang YJ, Chang L, Liang ZL, Xia JL, Dai QG, Hu YL, Mao QY, Zhu FC, Song YF, Gao F, Chen JT. Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months. Clin Vaccine Immunol. 2013 Dec;20(12):1805-11. doi: 10.1128/CVI.00491-13. Epub 2013 Oct 9.

  PMID: 24108780 DERIVED

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yue-Mei Hu, BS

  Jiangsu Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (1)