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

Study on the Immunogenicity and Safety of Inactivated Enterovirus Type 71 Vaccine Combined Administration With Recombinant Hepatitis B and Group A Meningococcal Vaccine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hand, Foot and Mouth Disease
• Intervention / Treatment: Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ); Biological: Recombinant Hepatitis B Vaccine; Biological: Group A meningococcal polysaccharide vaccine

Detailed Description

This study conducts a randomized, controlled design, enrolled infants over 6 months old as the participant, and setting up three parallel groups. Participants are randomly assigned to three groups. The first group is the inactivated enterovirus type 71 Vaccine (EV71 vaccine), Recombinant hepatitis B vaccine and Group A meningococcal polysaccharide vaccine combined administration group. The first dose of inactivated EV71 vaccine and Recombinant hepatitis B vaccine are combined administration on day 0, and the second dose of inactivated EV71 vaccine and Group A meningococcal polysaccharide vaccine are combined administration on day 30. The second group is the inactivated EV71 vaccine single administration group, with two doses of inactivated EV71 vaccine administered on day 0 and day 30 respectively. The third group is Recombinant hepatitis B vaccine and Group A meningococcal polysaccharide vaccine administration group, the Recombinant hepatitis B vaccine is administered on day 0, and the Group A meningococcal polysaccharide vaccine is administered on day 30. Each participant will be followed up 30 minutes, 24 hours, 48 hours, and 72 hours after each vaccination actively, and will be reported for 4-30 days to collect adverse reactions/events passively. All participants collect serum samples before administration (day 0) and second dose of administration (day 30), 30 days and 1 year after full-term administration (day 60 and 1 year). The serum samples of participants will be collected 5 years after full-term administration at the first and second group. The immunogenicity of the inactivated EV71 vaccine, Recombinant hepatitis B vaccine, and Group A meningococcal polysaccharide vaccine of three groups participants will be detected and analyzed.

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Province Centers for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Researchers believe that any situation that may affect observation and evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined immunization Group; 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 ); 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.; Biological: Recombinant Hepatitis B Vaccine; 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.; Biological: Group A meningococcal polysaccharide vaccine; 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).
Active Comparator: Single immunization Group; 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 ); 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.
Active Comparator: hepatitis B and Group A meningococcal polysaccharide vaccine Group; Administrate hepatitis B vaccine on day 0, and Group A meningococcal polysaccharide vaccine on day 30.	Biological: Recombinant Hepatitis B Vaccine; 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.; Biological: Group A meningococcal polysaccharide vaccine; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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。

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Stomatognathic Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Coxsackievirus Infections; Hepatitis B; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: JSEPI-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No