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CompletedNCT06442449Updated Jan 16, 2026

Booster Dose of sIPV Co-administered With MMR and HepA-I.

A Phase 4 interventional study of sIPV and MMR in Poliomyelitis, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Months to 22 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
889
Allocation
Randomized
Ages
18 Months to 22 Months
Sex
All
01

Study summary

This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.

Read the detailed description

The trial plans to enroll 960 infants aged 18 months (+4 months) who had completed three primary doses of sIPV vaccine and were assigned in a 2:2:2:1:1 ratio to four groups including trial group 1, trial group 2, control group 1, control group 2, control group 2, with informed consent from the participant's guardian. Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine. Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine. Control group 1 receive one dose of sIPV, control group 2 receive one dose of MMR vaccine, and control group 3 receive one dose of inactivated hepatitis A vaccine. About 3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection. Immediate reactions will be observed for 30 minutes after vaccination, and adverse events occured from 0 to day 30 after vaccination will be collected.

02

Conditions studied

  • Poliomyelitis

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Keywords

  • sIPV
  • immunogenicity
  • safety
  • Combination Vaccination
03

In context

Poliomyelitis

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

This study's enrollment of 889 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.

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

04

Who can participate

Ages eligible
18 Months to 22 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • (1) healthy toddlers aged 18 months (+4 months);
  • (2) completed three doses of sIPV primary immunization;
  • (3) completed one dose of MMR vaccination;
  • (4) able to provide proof of vaccination;
  • (5) able to provide legal proof of identity;
  • (6) The guardians of the participants were able to understand and agree to sign the .

Exclusion criteria

Exclusion Criteria:

  • (1) a history of vaccination with a polio-containing vaccine component in addition to three sIPV primary doses, according to the vaccination certificate;
  • (2) have received a second dose of MMR vaccine or a vaccine containing a vaccine for measles, mumps or rubella, or hepatitis A vaccine (inactivated or attenuated), according to the vaccination certificate;
  • (3) previous history of polio or measles or mumps or rubella or hepatitis A;
  • (4) known severe allergy to the vaccine or vaccine components, such as urticaria, dyspnea, angioedema;
  • (5) severe congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • (6) with diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, asplenia, functional asplenia, and infection);
  • (7) abnormal coagulation function (such as coagulation factor deficiency, abnormality), or obvious bleeding, hematoma, or ecchymosis after previous intramuscular injection or venipuncture;
  • (8) have/have had a serious neurological disease (e.g., encephalopathy, epilepsy, convulsions [other than febrile convulsions]) or psychosis, a family history of neurological disease or psychosis;
  • (9) receiving or other immunomodulatory therapy, cytotoxic therapy within the past 6 months, or planning to receive such treatment during the trial;
  • (10) have received an immune globulin or other blood products within the past 6 months or plan to receive such treatment during the trial;
  • (11) receipt of other vaccines within 30 days before vaccination with the investigational vaccines;
  • (12) receipt of within 28 days before vaccination with the investigational vaccine;
  • (13) receipt of subunit or inactivated vaccine within 7 days before vaccination with the investigational vaccine;
  • (14) acute diseases or acute episodes of chronic diseases within the past 7 days;
  • (15) Axillary temperature >37.0℃ if fever occurred before vaccination;
  • (16) which are unsuitable for participation in the clinical trial as judged by the investigators.
Terms in these criteria, in plain language(7)

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
889 participants (actual)

Study arms

  • Experimental
    Trial group 1

    vaccination with sIPV+MMR

    Biological: sIPV · Biological: MMR

  • Experimental
    Trial group 2

    vaccination with sIPV+HepA-I

    Biological: sIPV · Biological: HepA-I

  • Active comparator
    Control group 1

    vaccination with sIPV

    Biological: sIPV

  • Active comparator
    Control group 2

    vaccination with MMR

    Biological: MMR

  • Active comparator
    Control group 3

    vaccination with HepA-I

    Biological: HepA-I

Interventions

  • BiologicalsIPV

    vaccination with sIPV

  • BiologicalMMR

    vaccination with MMR

  • BiologicalHepA-I

    vaccination with HepA-I

06

What researchers measure

Primary outcomes

  1. seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)

    -The SCRs of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination.

    Time frame: 30 days

  2. SCRs of anti-meascles IgG antibodies

    SCRs of anti-measles IgG antibodies 30 days after vaccination

    Time frame: 30 days

  3. SCRs of anti-mumps IgG antibodies

    SCRs of anti-mumps IgG antibodies 30 days after vaccination

    Time frame: 30 days

  4. SCRs of anti-rubella IgG antibodies

    SCRs of anti-rubella IgG antibodies 30 days after vaccination

    Time frame: 30 days

  5. SCRs of anti-hepatitis A IgG antibodies

    SCRs of anti-hepatitis A antibodies 30 days after vaccination

    Time frame: 30 days

Secondary outcomes

  1. Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies

    SPRs and GMC of anti-measles virus IgG antibodies 30 days after vaccination.

    Time frame: 30 days

  2. SPRs and GMC of anti-mumps virus IgG antibodies

    SPRs and GMC of anti-mumps virus IgG antibodies 30 days after vaccination;

    Time frame: 30 days

  3. SPRs and GMC of anti-rubella virus IgG antibodies

    SPRs and GMC of anti-rubella virus IgG antibodies 30 days after vaccination;

    Time frame: 30 days

  4. SPRs and GMC of anti- hepatitis A virus IgG antibodies

    SPRs and GMC of anti- hepatitis A virus IgG antibodies 30 days after vaccination;

    Time frame: 30 days

  5. Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)

    -GMTs of antibody of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination;

    Time frame: 30 days

  6. - SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III)

    \- SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III) at day 30 after vaccination.

    Time frame: 30 days

  7. - Incidence of adverse reactions (ARs)

    \- Incidence of ARs from 0 to 30 days after vaccination;

    Time frame: 30 days

  8. - Incidence of serious adverse events (SAEs)

    \- Incidence of SAEs 0\~30 days after vaccination.

    Time frame: 30 days

07

Study locations

1 site
  • Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
    Nanjing, Jiangsu 210009, China
08

References and documents

Publications

  • Hu J, Han W, Chu K, Zhang H, Tuo L, Duan X, Li J, Yuan F, Luan C, Pan H, Jiao P. Immunogenicity and Safety of Sabin Strain Inactivated Poliovirus Vaccine Booster Dose Administered Separately or Concomitantly with Inactivated Hepatitis A Vaccine or Measles-Mumps-Rubella Combined Attenuated Live Vaccine: An Open-Labelled, Randomized, Controlled, Phase 4 Clinical Trial. Vaccines (Basel). 2025 Oct 23;13(11):1087. doi: 10.3390/vaccines13111087. PubMed 41295459 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06442449
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Aug 8, 2024
Primary completion
Sep 10, 2025
Completion
Oct 10, 2025
Last update
Jan 16, 2026

Study contacts

Pan Hongxing
principal investigator · Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)

Oversight

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

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Poliovirus Vaccine, Inactivated · Measles-Mumps-Rubella Vaccine

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