Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months

Healthy Volunteers Clinical Trial

Official title:

A Single-center, Randomized, Blinded, Different Doses, Positive Control, Phase II to Evaluate the Inactivated EV71 Vaccine Immunogenicity and Safety in Healthy Volunteers Aged 6 to 71 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05913024
• Other study ID #: 202101025
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: July 2023
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.

Description:

The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.

Qualified subjects were screened and randomly divided into low-dose group, high-dose group, and control group according to the ratio of 2:2:1. The experimental group was vaccinated with the experimental vaccine (low-dose or high-dose enterovirus 71 inactivated vaccine from Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.), and the control group was vaccinated with the control vaccine (enterovirus 71 inactivated vaccine produced by the Institute of Medical Biology of the Chinese Academy of Medical Sciences). All participants received two doses of the vaccine 28 days apart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 71 Months

Eligibility

Inclusion Criteria:

• Age 6-71 months, valid identification;

• Infants aged 6-11 months should be full-term (37-42 weeks gestation) and have a birth weight (2500g= weight =4000g);

• The subject's guardian voluntarily consented to the child's participation in the study and signed an informed consent form;

• The subject's guardian had the ability to learn about the study procedure and was able to participate in all planned follow-ups;

• Pre-enrollment axillary body temperature < 37.5°C.

Exclusion Criteria:

• Have received any previous HFMD vaccine;

• Previous history of hand, foot and mouth disease;

• History of allergies to any component of the study vaccine or substances used in the preparation process,or a history of severe adverse effects of vaccine/drug;

• Have a serious congenital malformation or chronic medical condition that may interfere with the conduct or completion of the study;

• History of seizures, epilepsy, encephalopathy, and psychosis (including family history);

• Have contraindications to intramuscular injections such as thrombocytopenia, any coagulopathy, or being treated with anticoagulants;

• Have an infectious disease with clinical or serological evidence;

• Patients with asplenia, splenectomy, or functional asplenia due to any condition;

• Patients with congenital or acquired immunodeficiency; or receive systemic corticosteroids within 3 months prior to enrollment, or be on other immunosuppressants prior to enrollment;

• Have received treatment with blood or blood-related products within 3 months prior to enrollment;

• Have acute illness or are in an acute exacerbation of chronic disease within 3 days prior to the first dose of vaccination, or antipyretic, analgesic, and antiallergic medications have been used;

• Have received any inactivated vaccine within 7 days before the first dose, and any live attenuated vaccine within 14 days prior to vaccination;

• Severely abnormal labor (dystocia at birth, instrumental delivery, excluding caesarean section) or history of asphyxia, neurological damage, IVF or multiple births, pathological jaundice (only for infants 6 to 11 months of age);

• Those who plan to move before the end of the study visit or who are away from the local area for an extended period of time during the scheduled study visit;

• Ongoing or planned participation in clinical trials of other drugs;

• The investigators considered that the participants had any conditions that might interfere with the assessment of the purpose of the study.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• Enterovirus Type 71 Vaccine
Participants received two doses of the vaccine, 28 days apart

Locations

Country	Name	City	State
China	Hunan Provincial Center for Disease Control and Prevention	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-EV71 serum neutralizing antibody positive conversion rate at 28 days after immunization	to evaluate immunogenicity of Enterovirus Type 71 Vaccine	28 days after two doses of vaccination
Primary	Geometric mean titer (GMT) and growth factor of anti-EV71 serum neutralizing antibody 28 days after immunization	to evaluate immunogenicity of Enterovirus Type 71 Vaccine	28 days after two doses of vaccination
Primary	Ratio of subjects with anti-EV71 serum neutralizing antibody titer = 1:8 28 days after immunization	to evaluate immunogenicity of Enterovirus Type 71 Vaccine	28 days after two doses of vaccination
Primary	Adverse events within 0-28 days after each dose of vaccination	to evaluate Safety of Enterovirus Type 71 Vaccine	28 days after each dose of vaccination