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A randomized, multi-center, control trial for Sabin-IPV replacement vaccination

A randomized, multi-center, control trial for Sabin-IPV replacement vaccination

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016767
Enrollment
Unknown
Registered
2018-06-22
Start date
2018-06-29
Completion date
Unknown
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

poliomyelitis

Interventions

Group 1:1st dose of IPV manufactured by Pasteur at the age of 2 months, 2nd and 3rd dose of IPV manufactured by Beijing Bio-Institute Biological Products at the age of 3 and 4 months respectively
Group 2:1st, 2nd and 3rd dose of IPV manufactured by Pasteur at the age of 2, 3 and 4 months, respectively

Sponsors

Beijing Center for Diseases Prevention and Control
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects aged more than 2 months on the day of enrollment; 2. Subjects parent(s)/legal guardian(s) are able to understand and sign informed consents with date; 3. guardians are able to participate in all follow-up visits and agree to comply all research procedures; 4. not less than 14 days after the last vaccination; 5. make sure body temperature is no more than 37.0 degree C.

Exclusion criteria

Exclusion criteria: (1) Allergic to the vaccine's active substance , any inactive substance or material used in preparation processes, or allergic to the vaccine; (2) Have serious chronic diseases or allergies; (3) Have a fever or acute illness.

Design outcomes

Primary

MeasureTime frame
poliovirus type I, II, III seroconversion rate;poliovirus type I, II, III antibody level (GMT);

Secondary

MeasureTime frame
incidence of adverse reactions;

Countries

China

Contacts

Public ContactWu Jiang
wj81732@hotmail.com+86 13381081732

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026