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

NCT01812135 | Withdrawn Phase 2 DMC

• 1 other identifier: EV71-1001-II-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection, Viral, Enterovirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The rates and severity of solicited and unsolicited adverse events in infants following immunization as a Measure of Safety and Tolerability

  2 months

Study Arms (3)

Group 1: 400U EV71 vaccine without adjuvant

EXPERIMENTAL

60 infants received 2 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant 28 days apart

Biological: 400 U EV71 vaccine with adjuvant

Group 2: 400U EV71 vaccine without adjuvant

EXPERIMENTAL

60 infants received 1 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant

Biological: 400 U EV71 vaccine with adjuvant

Group 3: 400U EV71 vaccine with adjuvant

EXPERIMENTAL

60 infants received 1 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant

Biological: 400 U EV71 vaccine with adjuvant

Interventions

400 U EV71 vaccine with adjuvant BIOLOGICAL

400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

Also known as: EV71 vaccine

Group 1: 400U EV71 vaccine without adjuvant; Group 2: 400U EV71 vaccine without adjuvant; Group 3: 400U EV71 vaccine with adjuvant

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Provided legal identification for the sake of recruitment.
• Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
• Birth weight more than 2500 grams

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 28 days
• Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Infections; Enterovirus Infections

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Yan-pin Li, MD

  Guangxi Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 29, 2021

Record last verified: 2013-03

Locations

CN (1)