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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-11-06

Brief Summary

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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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Detailed Description

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Conditions

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Poliomyelitis Vaccine Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Eupolio

Intervention Type BIOLOGICAL

Inactivated Polio vaccine (Sabin strains)

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.

Group Type EXPERIMENTAL

Eupolio

Intervention Type BIOLOGICAL

Inactivated Polio vaccine (Sabin strains)

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.

Group Type EXPERIMENTAL

Eupolio

Intervention Type BIOLOGICAL

Inactivated Polio vaccine (Sabin strains)

Interventions

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Eupolio

Inactivated Polio vaccine (Sabin strains)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes