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CompletedNCT06752174Updated Dec 30, 2024

A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

A Phase 3 interventional study of sIPV+bOPV and wIPV+bOPV in Poliomyelitis, sponsored by Beijing Minhai Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 60 Days to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-30.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
60 Days to 90 Days
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.

Read the detailed description

A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.

02

Conditions studied

  • Poliomyelitis

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Keywords

  • sIPV
  • bOPV
  • sequential immune
03

Who can participate

Ages eligible
60 Days to 90 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy permanent residents aged 2 months (over 60 days and less than 90 days);
  2. Infant's legal guardians agree to sign the informed consent forms voluntarily;
  3. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
  4. Armpit temperature ≤ 37.0 ℃

Exclusion criteria

Exclusion Criteria:

  1. Preterm birth (delivery before the 37th week of pregnancy).
  2. Previous vaccination against polio.
  3. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  4. History of polio.
  5. History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
  6. History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
  7. Individuals with immunodeficiency or receiving immunosuppression therapy.
  8. Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
  9. Known or suspected concomitant diseases include: respiratory disease, acute infection or active chronic disease, cardiovascular disease, liver and kidney disease, skin disease, mother with HIV infection.
  10. Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
  11. History of administration of live attenuated vaccines within 14 days.
  12. History of administration of subunit or inactivated vaccines within 7 days.
  13. Individuals with any acute diseases within 7 days, receiving antibiotics or antiviral therapy.
  14. Fever within 3 days (Armpit temperature ≥38.0 ℃).
  15. Use of any investigational product recently, or have any conditions that the investigator believes may affect the evaluation of the trial.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    study group

    study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants

    Biological: sIPV+bOPV

  • Active comparator
    control group

    control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants

    Biological: wIPV+bOPV

Interventions

  • BiologicalsIPV+bOPV

    2+1 sequential" immunization program (sIPV-sIPV-bOPV)

  • BiologicalwIPV+bOPV

    2+1 sequential" immunization program (wIPV-wIPV-bOPV)

05

What researchers measure

Primary outcomes

  1. The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody

    Time frame: Day 30 post full vaccination

Secondary outcomes

  1. GMT of poliovirus type I, type II and type III neutralizing antibody

    Time frame: Day 30 post full vaccination

  2. GMI of poliovirus type I, type II and type III neutralizing antibody

    Time frame: Day 30 post full vaccination

  3. The seropositive rates of poliovirus type I, type II and type III neutralizing antibody

    Time frame: Day 30 post full vaccination

  4. The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64

    Time frame: Day 30 post full vaccination

  5. Incidence of adverse reactions/events

    Time frame: 30 days after each dose of vaccination

  6. Incidence of serious adverse events (SAE)

    Time frame: From the first immunization to 6 months after the last immunization

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Study locations

1 site
  • Shandong Provincial Center for Diseases Control and Prevention
    Jinan, Shandong 250014, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06752174
Lead sponsor
Beijing Minhai Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Dec 30, 2024
Start date
Mar 8, 2023
Primary completion
Apr 12, 2024
Completion
Apr 12, 2024
Last update
Dec 30, 2024

Oversight

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

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