NCT03597919 is a Phase 4 clinical trial of Sabin IPV in Poliomyelitis, sponsored by Centers for Disease Control and Prevention, China.

Who is sponsoring NCT03597919?

NCT03597919 is sponsored by Centers for Disease Control and Prevention, China.

What drugs are being tested in NCT03597919?

Interventions in NCT03597919: Sabin IPV.

What condition does NCT03597919 study?

NCT03597919 studies Poliomyelitis.

Is NCT03597919 still recruiting?

NCT03597919 is currently completed. Last updated 24 June 2020.

Last reviewed 2020-06-24 · How we verify

NCT03597919

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China.

Completed Phase 4 Last updated 24 June 2020

What this trial tests

Phase 4 trial testing Sabin IPV in Poliomyelitis in 560 participants. Completed in 15 January 2020.

Timeline

28 May 2018

Primary endpoint
30 September 2019

15 January 2020

Quick facts

Lead sponsor	Centers for Disease Control and Prevention, China
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	560
Start date	28 May 2018
Primary completion	30 September 2019
Estimated completion	15 January 2020
Sites	1 location across China

Drugs / interventions tested

Sabin IPV — full drug profile →

Conditions studied

Poliomyelitis — all drugs for Poliomyelitis →

Sponsor

Centers for Disease Control and Prevention, China — full company profile →

Who can join

Adults 2 Months to 18 Months, any sex, with Poliomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In April 2017, WHO recommended that a two-dose, Inactivated Poliovirus Vaccine, IPV-only schedule at 4 months and 8 months of age can be used after polio eradication, with a schedule seroconversion target of at least 90%. However, there is no such data for China domestic Sabin strain IPVs to support a 2-dose schedule among Chinese infants. This research is to determine the seroconversion rates among two arms: Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose at 4 month of age, and the second dose at 8-11 month of age. Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4 month of age respectively. This schedule is currently recommended by manufacture's package insert for routine use. The hypothesis is the seroconversion will be above 90% in both groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immunogenicity of two-dose and three-dose vaccination schedules with Sabin inactivated poliovirus vaccine in China: An open-label, randomized, controlled trial.
Wang Y, Xu Q, Jeyaseelan V, Ying Z, et al · · 2021 · cited 3× · PMID 34327346 · DOI 10.1016/j.lanwpc.2021.100133

Verify or expand the search:

Other trials of Sabin IPV

Trials testing the same drug.

NCT03546634 — Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China · Phase 4 · completed

Other recruiting trials for Poliomyelitis

Currently open trials in the same condition.

NCT07457060 — Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine · Phase 4 · recruiting
NCT06895486 — Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation · Phase 2 · recruiting
NCT07354269 — Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations · Phase 4 · recruiting
NCT06137664 — Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines · Phase 1, PHASE2 · recruiting
NCT05644184 — Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh · Phase 2 · recruiting

Other Centers for Disease Control and Prevention, China trials

Trials by the same sponsor.

NCT05298800 — Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23 · Phase 4 · unknown
NCT04614597 — A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China · completed
NCT05087277 — Correlation Study of Isotype Switching and Neutralizing Capacity to the COVID-19 Variants Strain · unknown
NCT05072496 — Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine · completed
NCT03546634 — Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03597919 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centers for Disease Control and Prevention, China
Last refreshed: 24 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03597919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing