Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

Polio and Post-Polio Syndrome Clinical Trial

Official title:

A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902054
• Other study ID #: JSVCT042
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: April 2019
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 28, 2018
• Est. primary completion date: May 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 90 Days

Eligibility

Inclusion Criteria:

• Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;

• Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;

• Complying with the requirement of the study protocol;

• Axillary temperature = 37.0 °C;

Exclusion Criteria:

• Preterm or low birth weight infants;

• Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;

• History of polio;

• Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;

• History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;

• Autoimmune disease or immunodeficiency/immunosuppressive;

• Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;

• Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;

• Mother of the participant has HIV infection;

• Acute illness or acute exacerbation of chronic disease within the past 7 days;

• Had a high fever within the past 3 days (axillary temperature = 38.0°C);

• Receipt of any subunit or inactivated vaccine within the past 7 day;

• Receipt of any live attenuated vaccine within the past 14 days;

• Receipt of any blood product within the past 3 months;

• Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;

Related Conditions & MeSH terms

• Polio and Post-Polio Syndrome
• Postpoliomyelitis Syndrome

Intervention

Biological:
• Three-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
• Three-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
• Three-dose regimen of low dosage investigational sIPV
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
• Three-dose regimen of commercialized sIPV
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
• Three-dose regimen of commercialized IPV
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Diseases Control and Prevention	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Beijing Minhai Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The seroconversion rates (SCRs) of each group after three-dose regimen	Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level = 1:8, or those whose pre-immune antibody level = 1:8 and the increase of post-immune antibody level = 4 folds are considered seroconverted.	28~42 days
Primary	The post-immune geometric mean titer (GMT) of each group after three-dose regimen	GMT of each group 28~42 days after three-dose regimen.	28~42 days
Primary	The geometric mean fold increase (GMI) of each group after three-dose regimen	The GMI is the increase of post-immune GMT from pre-immune GMT.	28~42 days
Secondary	The incidences of solicited adverse events (AEs) of each group	Solicited AEs occurred within 7 days after each injection will be collected.	7 days
Secondary	The incidences of unsolicited adverse events (AEs) of each group	Unsolicited AEs occurred within 30 days after each injection will be collected.	30 days
Secondary	The incidences of serious adverse events (SAEs) of each group	SAEs occurred within 30 days after each injection will be collected.	30 days