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PoliomyelitisPhase 4NCT06442449

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

A Phase 4 study testing sIPV, MMR and HepA-I in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 22 monthsHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
sIPV, MMR and HepA-I
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
889 participants
Where
1 siteChina
Study dates
8 Aug 2024to 10 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

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 18 to 22 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • (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 informed consent.

Who cannot join

  • (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 autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, asplenia, functional asplenia, and HIV infection);
Show all 16Show fewer
  • (7) abnormal coagulation function (such as coagulation factor deficiency, platelet 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 immunosuppressive 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 investigational vaccines within 30 days before vaccination with the investigational vaccines;
  • (12) receipt of live attenuated vaccine 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I.

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.

Conditions
Poliomyelitis
Being tested
sIPV, MMR, HepA-I
Keywords
sIPV, immunogenicity, safety, Combination Vaccination
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sIPVBiological

    vaccination with sIPV

  • MMRBiological

    vaccination with MMR

  • HepA-IBiological

    vaccination with HepA-I

Study groups in NCT06442449
Study groupRoleWhat they receive
Trial group 1Experimentalvaccination with sIPV+MMR
Receives: Biological: sIPV; Biological: MMR
Trial group 2Experimentalvaccination with sIPV+HepA-I
Receives: Biological: sIPV; Biological: HepA-I
Control group 1Active comparatorvaccination with sIPV
Receives: Biological: sIPV
Control group 2Active comparatorvaccination with MMR
Receives: Biological: MMR
Control group 3Active comparatorvaccination with HepA-I
Receives: Biological: HepA-I

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

  2. SCRs of anti-meascles IgG antibodies

    SCRs of anti-measles IgG antibodies 30 days after vaccination

    Measured: 30 days

  3. SCRs of anti-mumps IgG antibodies

    SCRs of anti-mumps IgG antibodies 30 days after vaccination

    Measured: 30 days

  4. SCRs of anti-rubella IgG antibodies

    SCRs of anti-rubella IgG antibodies 30 days after vaccination

    Measured: 30 days

  5. SCRs of anti-hepatitis A IgG antibodies

    SCRs of anti-hepatitis A antibodies 30 days after vaccination

    Measured: 30 days

Secondary outcomes (8)

  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.

    Measured: 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;

    Measured: 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;

    Measured: 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;

    Measured: 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;

    Measured: 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.

    Measured: 30 days

  7. - Incidence of adverse reactions (ARs)

    • Incidence of ARs from 0 to 30 days after vaccination;

    Measured: 30 days

  8. - Incidence of serious adverse events (SAEs)

    • Incidence of SAEs 0~30 days after vaccination.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start8 Aug 2024
  3. Primary completion10 Sep 2025
  4. Study completion10 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial (RCT)
Masking
None (open label)
Enrolment
889 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06442449
Sponsor's protocol ID
PRO-sIPV-4003
Status last verified
May 2024
First submitted
29 May 2024
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sIPV, MMR and HepA-I in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 16 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 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III) (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06442449, which also lists 1 linked publication.

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 16 Jan 2026.

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