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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Poliomyelitis Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Vaccine Reaction Virus Diseases

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Health Index Multispecialty and Lying-in Clinic, Cavite City, Philippines

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eupolio

Biological

Inactivated Polio vaccine (Sabin strains)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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