Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273246

Enrollment

132

Registered

2011-01-10

Start date

2011-01-31

Completion date

2011-07-31

Last updated

2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand-foot-mouth Disease, Infection; Viral, Enterovirus

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).

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

Interventions

BIOLOGICAL100U 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

BIOLOGICAL200U 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

BIOLOGICAL400U 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

BIOLOGICALPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

6 Months to 11 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine	6 months	All adverse events were records. Blood cell and biochemistry were performed.

Secondary

Measure	Time frame	Description
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine	6 months	virus neutralization assays were performed.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026