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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07338851
- Acronym / sponsor ID
- sIPV/MMR/HepA-L-2025-01
- Conditions
- Polio, Measles, Rubella, Mumps, Hepatitis A
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (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
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
GMTs of antibodies against poliovirus
Time frame: 5 years after the four doses of sIPV immunization
GMCs of antibodies against measles, rubella, mumps
Time frame: 5 years after the two doses of MMR immunization
GMCs of antibodies against hepatitis A
Time frame: 5 years after the one doses of HepA-L immunization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polio and Measles, run by China National Biotec Group Company Limited at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijun Hu (029-82221350 ext. +86, huweijun0828@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seropositive rates of antibodies against poliovirus (time frame: 5 years after the four doses of sIPV immunization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.