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

Poliomyelitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431933
• Other study ID #: LG-VCCL002
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2023
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: LG Chem
• Contact: Study Lead
• Phone: +82-2-3777-1114
• Email: yangyj[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Poliomyelitis
• Vaccine Reaction

Intervention

Biological:
• Eupolio
Inactivated Polio vaccine (Sabin strains)

Locations

Country	Name	City	State
Philippines	Philippine Heart Center	Quezon City

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate reaction	Any side effects that occur within 30 minutes after the vaccination	30 minutes after each vaccination
Primary	Solicited adverse event	Expected local or systemic side effects after vaccination	7 days after each vaccination
Primary	Unsolicited adverse event	All unwanted or bad events after vaccination other than solicited adverse event	28 days after each vaccinations
Secondary	Seroprotection rate	Proportion of infants who have more than 8 protective antibody titers	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
Secondary	Geometric mean titers of neutralizing antibody against polio antigens	Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3	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
Secondary	Priming response	Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.	7 days after the boosting vaccination in the 4 Eupolio group
Secondary	Seroconversion rate	Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.	4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group