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

NCT ID: NCT07338851

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-30

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Polio Measles Rubella Mumps Hepatitis A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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5 years of follow-up group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaanxi Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

Hubei Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

Jiangsu Provincial Center for Disease Control and Prevention

UNKNOWN

Sponsor Role collaborator

Anhui Provincial Center for Disease Control and Prevention

UNKNOWN

Sponsor Role collaborator

Sichuan Provincial Center for Disease Control and Prevention

UNKNOWN

Sponsor Role collaborator

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Si County Center for Disease Control and Prevention

Suzhou, Anhui, China

Site Status

Feixiang District Center for Disease Control and Prevention

Handan, Hebei, China

Site Status

Sheyang County Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Site Status

Chenggu County Center for Disease Control and Prevention

Hanzhong, Shaanxi, China

Site Status

Yanhu District Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Site Status

Jiangyou Center for Disease Control and Prevention

Mianyang, Sichuan, China

Site Status

Countries

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China

Central Contacts

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Weijun Hu

Role: CONTACT

029-82221350 ext. +86

Facility Contacts

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Bingying Yang

Role: primary

13675570168 ext. +86

Yunlong Sun

Role: primary

0310-8555135 ext. +86

Siwei Xue

Role: primary

19850959658 ext. +86

Zhencai Zhang

Role: primary

0916-7203583 ext. +86

Jiehong Wang

Role: primary

0359-8688359 ext. +86

Jie Cao

Role: primary

13778072196 ext. +86

Other Identifiers

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sIPV/MMR/HepA-L-2025-01

Identifier Type: -

Identifier Source: org_study_id

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