Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months

Hand Foot and Mouth Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02889497
• Other study ID #: cycdc2016-6
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 31, 2016
• Last updated: September 6, 2016
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: August 2016
• Source: Beijing Chaoyang District Centre for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20900
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 71 Months

Eligibility

Inclusion Criteria:

• 8 Months to 71 Months (Healthy Children or Infants);

• Providing the subjects' legal identity certificate (birth certificate , residence booklet or ID card) and vaccination certificate, legal guardians can provide legal identity proof (resident booklet or ID card) so that the doctor can determine the subject identity to complete recruitment program;

• The subjects' guardians are able to understand and sign the informed consent voluntary. Guardians have the ability to use the thermometer ,dividing ruler and can fill out the Diary card ,follow-up card according to requirements;

• Persist for a 24 months visit.If doubtful HFMD case happen,the subject's guardian should send the subject to the medical institutions at above the county level and report this case to the investigator.The subjects who participate immunogenicity observation group can receive sample collection including blood,throat swab or anal awab according to program requirements.

Exclusion Criteria:

• Exclusion Criteria for the first dose:

• Subject with clinical diagnosis or suspect HFMD(Especially the history of herpangina);

• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine;

• History of seizures,convulsions or twitching ;Family history of progressive neurological disease;

• Autoimmune disease or immunologic deficiency.Any prior administration of immunodepressant in last 6month;

• History of asthma,thyroid ablation,angioneurotic edema, diabetes mellitus or malignant tumour;

• Alienia,functional asplenia,or any condition that cause asplenia or splenectomy;

• Diagnosed coagulation abnormalities (such as clotting factor deficiency, coagulation disorders, platelet disorder) or significant bruising or blood clotting disorder;

• Any acute disease or chronic disease attack in last 7 days;

• Any prior administration of blood products in last 3 month;

• Any prior administration of attenuated live vaccine in last 15 days , subunit or inactivated vaccines in last 7 days;

• Fever before vaccination, axillary temperature ?37.0?;

• Attend Other vaccine or drug clinical trials concurrent in 6 months;

• Any condition that in the opinion of the investigator?

• Exclusion Criteria for the second dose:

• Any exclusion criteria for the first dose happens after been enrolled;

• Newly HFMD diagnosed patients after been enrolled;

• Any condition that in the opinion of the investigator or ethics committee think should be eliminated.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand Foot and Mouth Disease
• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Biological:
• the first batch vaccine

• the second batch vaccine

• the third batch vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chaoyang District Centre for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Rate of Adverse reactions of Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months.	Adverse reactions associated with vaccine will be observed in Children Aged 6-71 Months after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.	24 months	Yes
Primary	Evaluate the seroconversion rate of EV71 antibodies in serum after vaccination.	The seroconversion rate of EV71 antibodies will be evaluated in serum at days 0 and 56.	56 days	No