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NCT Number: NCT07338851

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Si County Center for Disease Control and Prevention, Suzhou, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. seropositive rates of antibodies against poliovirus

    Time frame: 5 years after the four doses of sIPV immunization

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

  2. seropositive rates of antibodies against measles, rubella, mumps

    Time frame: 5 years after the two doses of MMR immunization

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

  3. seropositive rates of antibodies against hepatitis A

    Time frame: 5 years after the one doses of HepA-L immunization

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

Secondary outcomes

  1. GMTs of antibodies against poliovirus

    Time frame: 5 years after the four doses of sIPV immunization

    The GMTs of participants against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization.

  2. GMCs of antibodies against measles, rubella, mumps

    Time frame: 5 years after the two doses of MMR immunization

    The GMCs of participants against measles, rubella, mumps 5 years after the two doses of MMR immunization.

  3. GMCs of antibodies against hepatitis A

    Time frame: 5 years after the one doses of HepA-L immunization

    The GMCs of participants against hepatitis A 5 years after the one doses of HepA-L immunization.

Study contacts

Contact information is provided by the study sponsor or research team.

Weijun Hu

CONTACT

[email protected]

029-82221350 ext. +86

Sponsors and collaborators

Lead sponsor

China National Biotec Group Company Limited

Industry

Collaborators

  • Anhui Provincial Center for Disease Control and Prevention
  • Hubei Provincial Center for Disease Control and Prevention
  • Jiangsu Province Centers for Disease Control and Prevention
  • Shaanxi Provincial Center for Disease Control and Prevention
  • Sichuan Provincial Center for Disease Control and Prevention

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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