Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine

ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age56-84
SponsorSinovac Biotech Co., Ltd

About this trial

The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes

Eligibility criteria

Qualifiers

Infants of 2 months old (aged 56-84 days).

Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.

Be able to provide the vaccination records since birth.

The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).

Disqualifiers

History of any polio vaccination.

History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.

Premature infants (born before week 37 of gestation).

History of asphyxia rescue or nervous system injury.

Trial design

Treatments tested in this trial

  • 2wIPV+1sIPV
  • 1wIPV+2sIPV
  • 3wIPV
  • 3sIPV

Treatment groups

480 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Sinovac Biotech Co., Ltd

Lead sponsor

Aga Khan University

Collaborator