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

Phase 3CompletedNCT05431933

LG Chem2,001 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,001

Conditions

Poliomyelitis Vaccine Reaction

Interventions

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 8 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Health Index Multispecialty and Lying-in Clinic

Cavite City, Philippines

De La Salle Medical and Health Sciences Institue

Gov, D, Nabgybat Ave, Philippines

University of the Philippines - Philippine General Hospital

Manila, Philippines

Tropical Disease Foundateion, Inc.

Metro Manila, Philippines

Philippine Heart Center

Quezon City, Philippines

Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

Siriraj hospital

Bangkok, Thailand

Faculty of Medicine, Chiang Mai University

Chiang Mai, Thailand

Khon Kaen University, Srinagarind Hospital

Khon Kaen, Thailand

Hatyai Hospital

Songkhla, Thailand

Outcomes

Primary Outcomes

Immediate reaction

Any side effects that occur within 30 minutes after the vaccination

Time frame: 30 minutes after each vaccination

Solicited adverse event

Expected local or systemic side effects after vaccination

Time frame: 7 days after each vaccination

Unsolicited adverse event

All unwanted or bad events after vaccination other than solicited adverse event

Time frame: 28 days after each vaccinations

Secondary Outcomes

Seroprotection rate

Proportion of infants who have more than 8 protective antibody titers

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 of neutralizing antibody against polio antigens

Geometric mean titers and log2 titers for protective antibody against poliovirus type 1, 2, and 3

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

Priming response

Proportion of infants who have more than 8 protective antibody titers after boosting dose, depending on protective state before boosting dose.

Time frame: 7 days after the boosting vaccination in the 4 Eupolio group

Seroconversion rate

Proportion of infants who have more than 8 protective antibody titers after three primary vaccinations, depending on protective state before vaccination.

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