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

NCT07338851 | Not Yet Recruiting

• 1 other identifier: sIPV/MMR/HepA-L-2025-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 6

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.

Conditions

Polio; Measles; Rubella; Mumps; Hepatitis A

Outcome Measures

Primary Outcomes (3)

• seropositive rates of antibodies against poliovirus

  The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization.

  5 years after the four doses of sIPV immunization

• seropositive rates of antibodies against measles, rubella, mumps

  The percentage of participants with positive antibody against measles, rubella, mumps 5 years after the two doses of MMR immunization.

  5 years after the two doses of MMR immunization

• seropositive rates of antibodies against hepatitis A

  The percentage of participants with positive antibody against hepatitis A 5 years after the one doses of HepA-L immunization.

  5 years after the one doses of HepA-L immunization

Secondary Outcomes (3)

• GMTs of antibodies against poliovirus

  5 years after the four doses of sIPV immunization

• GMCs of antibodies against measles, rubella, mumps

  5 years after the two doses of MMR immunization

• GMCs of antibodies against hepatitis A

  5 years after the one doses of HepA-L immunization

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have taken part in the NCT04638985 or NCT04636827 trials and have completed the designated batches of sIPV, MMR or HepA-L vaccinations, with a time interval of 60 to 66 months since the fourth dose of sIPV, the second dose of MMR or the first dose of HepA-L vaccination at the time of enrollment.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Jiangsu Provincial Center for Disease Control and Prevention: collaborator
• Anhui Provincial Center for Disease Control and Prevention: collaborator
• Sichuan Provincial Center for Disease Control and Prevention: collaborator
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• China National Biotec Group Company Limited: lead

Study Sites (6)

Si County Center for Disease Control and Prevention

Suzhou, Anhui, China

Location

Feixiang District Center for Disease Control and Prevention

Handan, Hebei, China

Location

Sheyang County Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Location

Chenggu County Center for Disease Control and Prevention

Hanzhong, Shaanxi, China

Location

Yanhu District Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Location

Jiangyou Center for Disease Control and Prevention

Mianyang, Sichuan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum.

MeSH Terms

Conditions

Poliomyelitis; Measles; Rubella; Mumps; Hepatitis A

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Rubivirus Infections; Togaviridae Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Weijun Hu

CONTACT

029-82221350; huweijun0828@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (6)