NCT06209398

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 6 Months – 7 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-05-24
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: China