Clinical trial NCT05431933: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Vaccine Reaction
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 2001
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Immediate reaction
timeFrame: 30 minutes after each vaccination
measure: Solicited adverse event
timeFrame: 7 days after each vaccination
measure: Unsolicited adverse event
timeFrame: 28 days after each vaccinations
Secondary outcomes:
measure: Seroprotection rate
timeFrame: 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
measure: Geometric mean titers of neutralizing antibody against polio antigens
timeFrame: 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
measure: Priming response
timeFrame: 7 days after the boosting vaccination in the 4 Eupolio group
measure: Seroconversion rate
timeFrame: 4 weeks after the third vaccination in the 4 Eupolio group / 4 weeks after the first and second vaccination in the 3bOPV+2Eupolio group
Other outcomes:
Locations:
city: Cavite City
country: Philippines
facility: Health Index Multispecialty and Lying-in Clinic
city: Gov, D, Nabgybat Ave
country: Philippines
facility: De La Salle Medical and Health Sciences Institue
city: Manila
country: Philippines
facility: University of the Philippines - Philippine General Hospital
city: Metro Manila
country: Philippines
facility: Tropical Disease Foundateion, Inc.
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
city: Bangkok
country: Thailand
facility: Siriraj hospital
city: Chiang Mai
country: Thailand
facility: Faculty of Medicine, Chiang Mai University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University, Srinagarind Hospital
city: Songkhla
country: Thailand
facility: Hatyai Hospital
Study officials:
References: