Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05431933
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
LG Chem

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated.

As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.


Condition or disease Intervention/treatment Phase
Poliomyelitis Vaccine Reaction Biological: Eupolio Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Open-label, Interventional Phase 3b Study to Evaluate the Safety, One-year Antibody Persistence, Priming Immune Responses of Three Doses of Eupolio Inj. (Inactivated Polio Vaccine (Sabin Strains)) and Immunogenicity of Two Doses of Eupolio Inj. Following Three Doses of bOPV in Infants
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Safety group
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age. Only safety will be evaluated for this arm.
 Biological: Eupolio
Inactivated Polio vaccine (Sabin strains)
Experimental: Immunogenicity group 1 (4 Eupolio including 1 boosting dose)
Three doses of Eupolio will be administered at 6, 10 and 14 weeks of age, and additional single dose of Eupolio will be administered one year after the three primary vaccinations.
 Biological: Eupolio
Inactivated Polio vaccine (Sabin strains)
Experimental: Immunogenicity group 2 (3bOPV+2 Eupolio)
bOPV will be administered at 6, 10 and 14 weeks of age, and Eupolio will be administered at 14 and 40 weeks of age.
 Biological: Eupolio
Inactivated Polio vaccine (Sabin strains)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immediate reaction [ Time Frame: 30 minutes after each vaccination ]
    Any side effects that occur within 30 minutes after the vaccination

  2. Solicited adverse event [ Time Frame: 7 days after each vaccination ]
    Expected local or systemic side effects after vaccination

  3. Unsolicited adverse event [ Time Frame: 28 days after each vaccinations ]
    All unwanted or bad events after vaccination other than solicited adverse event


Secondary Outcome Measures :
  1. Seroprotection rate [ Time Frame: 4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group/ 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group ]
    Proportion of infants who have more than 8 protective antibody titers

  2. Geometric mean titers of neutralizing antibody against polio antigens [ Time Frame: 4 weeks after the third vaccination, 52 weeks after the third vaccination and 7 days after the boosting vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group ]
    Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3

  3. Priming response [ Time Frame: 7 days after the boosting vaccination in the 4 Eupolio group ]
    Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.

  4. Seroconversion rate [ Time Frame: 4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group ]
    Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants in stable health
  • Male or female 6 to 8 weeks of age
  • Signed informed consent by the infant's parent(s) or legally acceptable representative(s)

Exclusion Criteria:

  • Known or suspected poliomyelitis
  • Known or suspected febrile(symptom of a fever), or chronic illnesses
  • Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration or intake of drug preventing fever
  • Known or suspected immune disorders (abnormal activity in protective system in human body) or received immunosuppressive therapy (treatment for weaken protective system in human body)
  • Previous use of blood or blood-derived products
  • Previous use of polio vaccines
  • Seizures (temporary abnormalities in muscle tone or movements due to abnormal activity in the brain)
  • Bleeding disorders
  • Household contact or intimate exposure with a confirmed case of polio
  • Any history of allergy (hypersensitivity) to the components of the polio vaccine
  • Participation in another interventional clinical trial simultaneously or within 30 days
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431933


Contacts
Layout table for location contacts
Contact: Study Lead +82-2-3777-1114 yangyj@lgchem.com

Sponsors and Collaborators
LG Chem
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT05431933    
Other Study ID Numbers: LG-VCCL002
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Poliomyelitis
Myelitis
Central Nervous System Infections
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases