Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

Poliomyelitis Clinical Trial

Official title:

A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985320
• Other study ID #: PRO-sIPV-1001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 5, 2016
• Last updated: July 25, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

Description:

This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 49 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;

• Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;

• Proven legal identity;

• Participants (= 18 years old), or guardians of the participants (< 18 years old) 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:

• Breast feeding, pregnant, or expected to conceive in the next 60 days;

• 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;

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

• Autoimmune disease or immunodeficiency/immunosuppressive;

• serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;

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

• History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;

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

• Long term history of alcoholism or drug abuse;

• Receipt of any of the following products:

1. Any subunit or inactivated vaccine within the past 7 day;

2. Any live attenuated vaccine within the past 14 days;

3. Any other investigational medicine(s) within the past 30 days;

4. Any blood product within the past 3 months;

5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;

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

• Axillary temperature > 37.0 °C;

• Infant participants with prior vaccination of poliovirus;

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

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Single-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
• Single-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
• Three-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
• Three-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
• Three-dose regimen of low dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech 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	Pizhou City Center for Disease Control and Prevention	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech 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 of the phase II trial 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.	90 days
Primary	The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen	GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.	90 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.	90 days
Secondary	The incidences of solicited adverse events (AEs) of each group in both phase I and II trials	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 in both phase I and II trials	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 in both phase I and II trials	SAEs occurred within 30 days after each injection will be collected.	30 days