the Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines

China National Biotec Group (CNBG)

Status: Not yet enrolling

Conditions: Rubella; Hepatitis A; Polio; Mumps; Measles

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07338851

sIPV/MMR/HepA-L-2025-01

Details and patient eligibility

About

This study evaluated the antibody persistence of Chinese children five years after they received four doses of sIPV, two doses of MMR vaccine and one dose of HepA-L vaccine.

Full description

This is a follow-up study of several previous clinical trials (A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR) : NCT04054882, NCT04638985; A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA): NCT04053010, NCT04636827). Five years after vaccination with sIPV, MMR or HepA-L, blood samples were collected from the followed-up children to assess the antibody levels and seropositive rates against polio, measles, rubella, mumps and hepatitis A. This study was conducted in six provinces of China.

Enrollment: 600 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in the NCT04638985 or NCT04636827, and who have completed the vaccination of designated batch numbers of sIPV, MMR or HepA-L vaccines;
• The time window from the day of enrollment to the date when the participants received the fourth dose of sIPV vaccine, the second dose of MMR vaccine, or the first dose of HepA-L vaccine was 60 to 66 months.
• The informed consent form shall be signed by the participant or his/her legal guardian and dated.

Exclusion criteria

• None.

Trial design

600 participants in 1 patient group

5 years of follow-up group

Description:

All the children who met the protocol criteria and had been five years since their last doses of sIPV, MMR or HepA-L were included.