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NCT03526978

An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants

Completed Phase 3 Last updated 25 January 2019
What this trial tests

Phase 3 trial testing Investigational sIPV in Poliomyelitis in 1,200 participants. Completed in 18 April 2018.

Timeline
8 August 2017
Primary endpoint
18 October 2017
18 April 2018

Quick facts

Lead sponsorSinovac Biotech Co., Ltd
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment1,200
Start date8 August 2017
Primary completion18 October 2017
Estimated completion18 April 2018
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sinovac Biotech Co., Ltd — full company profile →

Who can join

Adults 60 Days to 90 Days, any sex, with Poliomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial.
    Hu Y, Wang J, Zeng G, Chu K, et al · · 2019 · cited 29× · PMID 30958543 · DOI 10.1093/infdis/jiy736
  2. Effects of maternal antibodies in infants on the immunogenicity and safety of inactivated polio vaccine in infants.
    Gao S, Wei M, Chu K, Li J, et al · · 2022 · cited 3× · PMID 35394898 · DOI 10.1080/21645515.2022.2050106
  3. Sustained Immune Persistence Five Years Post-Completion of Four-Dose sIPV Vaccination.
    Kai C, Yurong L, Sheng L, Yongmei S, et al · · 2025 · PMID 40266111 · DOI 10.3390/vaccines13030253

Verify or expand the search:

Other trials of Investigational sIPV

Trials testing the same drug.

Other recruiting trials for Poliomyelitis

Currently open trials in the same condition.

Other Sinovac Biotech Co., Ltd trials

Trials by the same sponsor.

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Data sources for this page

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