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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT04614597
Date of registration:	28/10/2020
Prospective Registration:	Yes
Primary sponsor:	Centers for Disease Control and Prevention, China
Public title:	A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China
Scientific title:	A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin Strain Inactivated Poliovirus Vaccine in China
Date of first enrolment:	October 29, 2020
Target sample size:	810
Recruitment status:	Enrolling by invitation
URL:	https://clinicaltrials.gov/show/NCT04614597
Study type:	Observational
Study design:
Phase:

Countries of recruitment
China

Contacts

Name:	Zhijie An, MPH
Address:
Telephone:
Email:
Affiliation:	Centers for Disease Control and Prevention, China

Name:	Zijian Feng, MD
Address:
Telephone:
Email:
Affiliation:	Centers for Disease Control and Prevention, China

Name:	Zundong Yin
Address:
Telephone:
Email:
Affiliation:	Centers for Disease Control and Prevention, China

Key inclusion & exclusion criteria

Inclusion Criteria:

- Parent or legal guardian agree to participate in the follow study.

- The subject was vaccinated either two doses or three doses Sabin IPV ,collected two
blood samples and laboratory test results were available per protocol of pervious
study

- The subject is at least 18 months age.

Exclusion Criteria:

- Parent or legal guardian does not agree to participate in the follow up study.

- The subject has received any polio vaccine product beyond the protocol of previous
study.

Age minimum: 18 Months
Age maximum: 3 Years
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Biological: Sabin strain inactivated polio vaccine

Primary Outcome(s)

Antibody persistence [Time Frame: 1 month]

Secondary Outcome(s)

Neutralizing antibody titers [Time Frame: 1 month]

Secondary ID(s)

201935

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shandong Province Centers for Disease Control and Prevention

World Health Organization

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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