Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine

NCT06209398 | Unknown Phase 4

• 1 other identifier: JSEPI-005
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.

Conditions

Hand, Foot and Mouth Disease

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of inactived Enterovirus type 71 Vaccine Combined With Hepatitis B andGroup A meningococcal polysaccharide vaccine

  To analyze the immunogenicity after inactived EV71 vaccine, hepatitis B vaccine, Group A meningococcal polysaccharide vaccine were adminisataed after combined use and single vaccination

  1 month, 1 years and 5 years after full term immunization.

• Safety of Enterovirus type 71 Vaccine Combined With Hepatitis B and Group A meningococcal polysaccharide vaccine

  To compare the adverse reactions of inactived EV71 vaccine, hepatitis B vaccine and Group A meningococcal polysaccharide vaccine after combined use and single vaccination.

  30 minutes, 24 hours, 48 hours, and 72 hours of active follow-up, with passive reporting for 4-30 days。

Study Arms (3)

Combined immunization Group

EXPERIMENTAL

The first dose of inactivated EV71 vaccine and the third dose of hepatitis B vaccine were combined administered on day 0, and the second dose of EV71 vaccine and Group A meningococcal polysaccharide vaccine were jointly administered on day 30.

Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ); Biological: Recombinant Hepatitis B Vaccine; Biological: Group A meningococcal polysaccharide vaccine

Single immunization Group

ACTIVE COMPARATOR

On the 0th and 30th day, receive two doses of inactivated EV71 vaccine respectively. On the 60th day, both hepatitis B vaccine and Group A meningococcal polysaccharide vaccine were administrated.

Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell )

hepatitis B and Group A meningococcal polysaccharide vaccine Group

ACTIVE COMPARATOR

Administrate hepatitis B vaccine on day 0, and Group A meningococcal polysaccharide vaccine on day 30.

Biological: Recombinant Hepatitis B Vaccine; Biological: Group A meningococcal polysaccharide vaccine

Interventions

Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ) BIOLOGICAL

Used for EV71 virus susceptible individuals aged 6 months to 5 years. Each bottle (bottle) contains 0.5ml of neutralizing antibody with a potency of no less than 3.0EU for the inactivated 71 type intestinal disease vaccine. Intramuscular injection into the deltoid muscle of the upper arm. The immunization program consists of 2 doses with 1-month interval.

Combined immunization Group; Single immunization Group

Recombinant Hepatitis B Vaccine BIOLOGICAL

Each vaccine bottle (tube) is 0.5ml, containing 10ug of HBsAg and inject into the upper deltoid muscle. The immunization program consists of three doses, administered at 0, 1, and 6 months respectively. Newborns are given the first dose within 24 hours after birth, with one dose of vaccine administered each time.

Combined immunization Group; hepatitis B and Group A meningococcal polysaccharide vaccine Group

Group A meningococcal polysaccharide vaccine BIOLOGICAL

This product is made by lyophilizing the purified polysaccharide antigen obtained from Group A meningococcus liquid culture. The vaccination targets children aged 6 months to 15 years old, and the initial immunization age starts from 6 months old. Infants and young children aged 6 to 12 months old are vaccinated with 2 doses of 30 micrograms, with an interval of 3 months. Subcutaneously inject 0.5ml into the lateral deltoid muscle of the upper arm at a dose of 30 μg of polysaccharide antigen (0.5ml).

Combined immunization Group; hepatitis B and Group A meningococcal polysaccharide vaccine Group

Eligibility Criteria

• Age: 6 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 6-7 months with no history of vaccination within the past month and normal intelligence.
• Healthy individuals determined by researchers after inquiring about medical history and physical examination.
• The recipients are able to comply with the requirements of the research protocol and undergo immunogenicity testing.
• Individuals without contraindications.
• Underarm temperature ≤ 37 ℃.
• Obtain informed consent from the recipient's guardian and sign an informed consent form.

You may not qualify if:

• Individuals with any serious illness.
• Individuals who are allergic to any ingredient in the research vaccine.
• Individuals with a history of neurological symptoms or signs.
• Individuals with bleeding constitution or prolonged bleeding time.
• Individuals who have had hand, foot, and mouth disease, hepatitis B, and epidemic cerebrospinal meningitis in the past.
• Individuals who have received other vaccines or immunoglobulin injections or any investigational drugs within the past 4 weeks.
• Infected individuals who have had any acute illness or require systemic antibiotic or antiviral treatment within the past 7 days.
• Individuals who have experienced fever (axillary temperature ≥ 38 ℃) within the past 3 days.
• Participating in another researcher.
• Individuals with a history or family history of allergies, seizures, epilepsy, encephalopathy, and mental illness.
• Patients with thrombocytopenia or other coagulation disorders that may cause contraindications for intramuscular injection.
• Patients with severe chronic diseases.
• Known or suspected concurrent diseases include: respiratory system diseases, acute or chronic disease activity period, HIV infection in the mother or research subject of the child, cardiovascular disease, severe hypertension, malignant tumor treatment period, and skin disease patients.
• Endemic disease patients.
• Those who plan to leave their place of residence before the end of the study.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Institute of Medical Biology, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Jiangsu Province Centers for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 17, 2024
• Study Start: May 24, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)