PolioNCT07338851
the Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines
An observational study of Polio and Measles, run by China National Biotec Group Company Limited at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 600 participants
- Where
- 6 sitesChina
- Study dates
- 30 Jan 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Feixiang District Center for Disease Control and Prevention
Handan, Hebei
Yunlong Sun, 0310-8555135 ext. +86, fxjm@163.com
Chenggu County Center for Disease Control and Prevention
Hanzhong, Shaanxi
Zhencai Zhang, 0916-7203583 ext. +86, 3391761505@qq.com
Jiangyou Center for Disease Control and Prevention
Mianyang, Sichuan
Jie Cao, 13778072196 ext. +86, 805703067@qq.com
Si County Center for Disease Control and Prevention
Suzhou, Anhui
Bingying Yang, 13675570168 ext. +86, 384647478@qq.com
Sheyang County Center for Disease Control and Prevention
Yancheng, Jiangsu
Siwei Xue, 19850959658 ext. +86, 2802269366@qq.com
Yanhu District Center for Disease Control and Prevention
Yuncheng, Shanxi
Jiehong Wang, 0359-8688359 ext. +86, 391748817@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Polio, Measles, Rubella, Mumps, Hepatitis A
- Medical subject headings
- Poliomyelitis, Measles, Rubella, Mumps, Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years after the one doses of HepA-L immunization
Secondary outcomes (3)
GMTs of antibodies against poliovirus
The GMTs of participants against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization.
Measured: 5 years after the four doses of sIPV immunization
GMCs of antibodies against measles, rubella, mumps
The GMCs of participants against measles, rubella, mumps 5 years after the two doses of MMR immunization.
Measured: 5 years after the two doses of MMR immunization
GMCs of antibodies against hepatitis A
The GMCs of participants against hepatitis A 5 years after the one doses of HepA-L immunization.
Measured: 5 years after the one doses of HepA-L immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolioStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shaanxi Provincial Center for Disease Control and Prevention, Hebei Provincial Center for Disease Control and Prevention, Jiangsu Province Centers for Disease Control and Prevention, Anhui Provincial Center for Disease Control and Prevention, Sichuan Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338851
- Sponsor's protocol ID
- sIPV/MMR/HepA-L-2025-01
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided