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AzTrials

PoliomyelitisPhase 4NCT05432141

A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

A Phase 4 study testing sIPV vaccine /DTaP vaccine and sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 2 sites 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

The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2… Read more about this study

Who is it for?
Ages 2 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
sIPV vaccine /DTaP vaccine and sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,200 participants
Where
2 sitesChina
Study dates
13 Jun 2022to 13 Dec 2022
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 2 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants aged 2-3 months should be involved in primary immunization and they have not received Sabin strain inactivated polio vaccine (Vero Cell) in the past;
  • Children aged 18 months should be immunized with the first three doses of Sabin strain inactivated polio vaccine (Vero Cell) and they have not received any inactivated or attenuated live vaccines in the past 14 days;
  • The guardian agrees to sign the informed consent and voluntarily use the mobile APP to participate in the follow-up visits.

Who cannot join

  • Allergic to the active ingredient in the vaccine, any inactive ingredient, or substance used in the manufacturing process;
  • Allergic to this product or similar vaccines in the past;
  • Patients with severe chronic diseases or allergies;
  • Patients with fever or acute illness.
  • The Exclusion Criteria for the Second and Third Doses:
  • Any serious adverse events that are causally related to vaccination;
Show all 12Show fewer
  • Severe anaphylaxis or hypersensitivity after vaccination (including hives and rashes within 30 minutes of vaccination);
  • Any confirmed or suspected autoimmune or immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
  • Acute or newly emerging chronic diseases occur at the time of vaccination;
  • Other reactions (including severe pain, severe swelling, severe limitation of movement, persistent high fever, severe headache, or other systemic or local reactions), as determined by the investigator;
  • Having an acute illness at the time of vaccination (acute illness is defined as moderate or severe illness with or without fever);
  • Axillary temperature >37℃ during vaccination.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Gaoan Center for Disease Control and Prevention

    Gao’an, Jiangxi, 330899

  • Shangli County Center for Disease Control and Prevention

    Pingxiang, Jiangxi

Other trials in China

About this study

Official title: Safety Observation of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Primary Immunization, Booster Immunization and Simultaneous Vaccination With Other Vaccines in Infants

The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.

Read the detailed description

This study is an open and observational phase Ⅳ clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.A total of 3200 subjects including 2000 subjects aged 2~3 months in primary immunization group,1200 subjects aged 18 months in primary immunization group will be enrolled and will receive sIPV vaccine or sIPV vaccine and other vaccines simultaneously.

Conditions
Poliomyelitis
Being tested
sIPV vaccine /DTaP vaccine, sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine
Medical subject headings
Poliomyelitis

What participants receive

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

  • sIPV vaccine /DTaP vaccineBiological

    All subjects received 3 doses of sIPV vaccines and 3 doses of DTaP vaccines. Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.

  • sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccineBiological

    All subjects will receive 1 dose of sIPV and 2 doses of hepatitis A inactivated vaccine/or 1 dose of attenuated hepatitis A vaccine and 1 dose of MMR vaccine.Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.

Study groups in NCT05432141
Study groupRoleWhat they receive
Primary immunization groupExperimentalA total of 2000 infants aged 2-3 months will randomly assigned to two groups according to 1:1 using scratch cards: 1000 infants in the sIPV vaccine group and 1000 infants in the sIPV vaccine group plus DTaP vaccine group
Receives: Biological: sIPV vaccine /DTaP vaccine
Booster immunization group of sIPV vaccineExperimentalA total of 1200 children aged 18 months will randomly assigned to four groups according to 2:2:1:1 using scratch cards: 400 in the sIPV booster group, 400 in the sIPV booster group plus inactivated hepatitis A vaccine simultaneously, 200 in the sIPV booster group plus MMR simultaneously, and 200 in the sIPV booster group plus attenuated hepatitis A vaccine.
Receives: Biological: sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine

What is being measured

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

  1. Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine

    Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine

    Measured: Within 0~7 days after primary immunization

Secondary outcomes (8)

  1. Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine

    Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine.

    Measured: Within 0~30 days after primary immunization

  2. Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine

    Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine .

    Measured: Within 0~7 days after booster immunization

  3. Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine

    Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine.

    Measured: Within 0~30 days after booster immunization

  4. Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine

    Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine.

    Measured: Within 0-7 days after primary immunization combined with DTaP vaccine

  5. Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine

    Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine combined with DTaP vaccine.

    Measured: Within 0-30 days after primary immunization combined with DTaP vaccine

  6. Incidence of adverse reactions after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine

    Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine.

    Measured: Within 0~7 days after booster immunization combined with inactivated hepatitis A vaccine

  7. Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine

    Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine combined with MMR vaccine or attenuated hepatitis A vaccine.

    Measured: Within 0 ~14 days after booster immunization

  8. Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine

    Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.

    Measured: Within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.

Timeline

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

  1. First posted27 Jun 2022
  2. Study start13 Jun 2022
  3. Primary completion13 Sep 2022
  4. Study completion13 Dec 2022

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
Masking
None (open label)
Enrolment
3,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432141
Sponsor's protocol ID
PRO-sIPV-MA4001-JX
Status last verified
Jun 2022
First submitted
20 Jun 2022
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guo S, Li Z, Zheng M, Wu F, Sun J, Tuo L, Li S, Li X, Wei L, Xia Z, Xie P, Chen X, Zhao Y, Gao Y, Yu D. Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China. Vaccine. 2024 Aug 30;42(21):126183. doi: 10.1016/j.vaccine.2024.126183. Epub 2024 Jul 31.

    PubMed 39088987

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sIPV vaccine /DTaP vaccine and sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 2 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 12 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

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?

Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine (time frame: Within 0~7 days after primary immunization). 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 NCT05432141, 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 12 Jan 2023.

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