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A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults

A Randomized, Observer-Blind, Positive-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults Aged 18-54 Years

NCT06101173•CanSino Biologics Inc.

View on ClinicalTrials.gov

Summary

This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.

Eligibility

Age

18 - 54 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and female volunteers aged 18 to 54 years at time of screening.
•Participants who can understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent.
•Healthy or in stable health participants with pre-existing, stable, well-controlled disease, defined as mild disease or medical condition not requiring medical therapy or not requiring a change in medical therapy due to worsening of disease during the 6 months before enrollment may be enrolled at the discretion of the investigator.
•Female participants of childbearing potential must have a negative pregnancy test at screening and before the administration of investigational vaccine and have been using/ agree to use an adequate form of contraception 30 days prior to screening until 180 days post administration.
•Male participants must agree to use adequate contraception 30 days prior to screening until 180 days after the vaccination.

Exclusion Criteria

•Tympanic temperature \>37.4°C.
•Evidence of excessive alcohol or drug abuse.
•Have received any polio vaccines within 6 months prior to screening.
•History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
•Pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
•History of epilepsy or convulsions.
•Have developmental cognitive disability, dementia, or intellectual disabilities.
•Immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of \<20 mg/day or equivalent is allowed. Inhaled and topical corticosteroids are allowed.
•Current diagnosis of polio or history of polio infection.
•Positive for HIV, Hepatitis B or Hepatitis C.
+8 more criteria

Locations (2)

Nucleus Network Pty Ltd

Geelong, Victoria, Australia

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Key Dates

Start Date

January 15, 2024

Primary Completion Date

March 15, 2024

Completion Date

September 11, 2024

Last Updated

December 4, 2024

Enrollment

ACTUAL participants

Conditions

Poliomyelitis

Interventions

Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)

BIOLOGICAL

Inactivated poliomyelitis vaccine (IPOL)

BIOLOGICAL

VLP-Polio

BIOLOGICAL

IPOL

BIOLOGICAL

VLP-Polio

BIOLOGICAL

IPOL

BIOLOGICAL

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

NCT05644184

Poliomyelitis

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RECRUITINGPHASE2/PHASE3

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

NCT06947499

DiphtheriaTetanus+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults

Inclusion Criteria

Exclusion Criteria

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease

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

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants