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Not yet recruitingNCT07338851Updated Jan 14, 2026

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

An observational study in Polio, Measles and Rubella, sponsored by China National Biotec Group Company Limited. Not yet recruiting at 6 sites in China. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by China National Biotec Group Company Limited (part of Sinopharm) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
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Study 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 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.

02

Conditions studied

  • Polio
  • Measles
  • Rubella
  • Mumps
  • Hepatitis A
03

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's planned enrollment of 600 is close to the median of 600 across 21 observational studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

China National Biotec Group Company Limited is the lead sponsor of 37 studies on the registry; 2 are open to participants now.

First submitted after China National Biotec Group Company Limited became part of Sinopharm.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form shall be signed by the participant or his/her legal guardian and dated.

Exclusion criteria

Exclusion Criteria:

  • None.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. GMTs of antibodies against poliovirus

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

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

  2. GMCs of antibodies against measles, rubella, mumps

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

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

  3. GMCs of antibodies against hepatitis A

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

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

07

Study locations

6 sites
  • Si County Center for Disease Control and Prevention
    Suzhou, Anhui, China
  • Feixiang District Center for Disease Control and Prevention
    Handan, Hebei, China
  • Sheyang County Center for Disease Control and Prevention
    Yancheng, Jiangsu, China
  • Chenggu County Center for Disease Control and Prevention
    Hanzhong, Shaanxi, China
  • Yanhu District Center for Disease Control and Prevention
    Yuncheng, Shanxi, China
  • Jiangyou Center for Disease Control and Prevention
    Mianyang, Sichuan, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07338851
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
First posted
Jan 14, 2026
Start date
Jan 30, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 14, 2026

Study contacts

Weijun Hu
Contact
huweijun0828@163.com
029-82221350 ext. +86

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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