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

NCT05913024 | Completed Phase 2

• 1 other identifier: 202101025
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Enterovirus Type 71 Vaccine

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),high dose

EXPERIMENTAL

Participants received two doses of the vaccine, 28 days apart

Biological: Enterovirus Type 71 Vaccine

Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),low dose

EXPERIMENTAL

Participants received two doses of the vaccine, 28 days apart

Biological: Enterovirus Type 71 Vaccine

Enterovirus Type 71 Vaccine,Inactivated(Human Diploid Cell)

ACTIVE COMPARATOR

Participants received two doses of the vaccine, 28 days apart

Biological: Enterovirus Type 71 Vaccine

Interventions

Enterovirus Type 71 Vaccine BIOLOGICAL

Participants received two doses of the vaccine, 28 days apart

Enterovirus Type 71 Vaccine,Inactivated(Human Diploid Cell); Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),high dose; Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),low dose

Eligibility Criteria

• Age: 6 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 410005, China

Location

Study Officials

• Du lin, master

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: October 19, 2021
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-07

Locations

CN (1)