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

ClinicalTrials.gov ID

NCT07338851

Lead Sponsor

China National Biotec Group Company LimitedINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

600Estimated

Last Update Posted

Jan 14, 2026Actual

Start Date

Jan 30, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

Evaluation on the Persistence of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell), Combined Live Attenuated Measles, Mumps and Rubella Vaccine and Freeze-dried Live Attenuated Hepatitis A Vaccine in Chinese Children: Up to 5 Years of Follow-up

Brief Summary

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.

Detailed 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.

• Polio
• Measles
• Rubella
• Mumps
• Hepatitis A

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

China National Biotec Group Company LimitedINDUSTRY

Collaborators

Shaanxi Provincial Center for Disease Control and PreventionOTHER

Hebei Provincial Center for Disease Control and PreventionUNKNOWN

Jiangsu Province Centers for Disease Control and PreventionNETWORK

Anhui Provincial Center for Disease Control and PreventionOTHER_GOV

Sichuan Provincial Center for Disease Control and PreventionUNKNOWN

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