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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

May 24, 2018

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Hand, Foot and Mouth Disease
Interventions
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).

Trial Locations (1)

210009

Jiangsu Province Centers for Disease Control and Prevention, Nanjing

All Listed Sponsors
collaborator

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

lead

Jiangsu Province Centers for Disease Control and Prevention

NETWORK