The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

NCT ID: NCT01048190

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-03-31

Brief Summary

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Detailed Description

The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Infants I-1

Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Intervention Type: BIOLOGICAL

15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Infants I-2

15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Intervention Type: BIOLOGICAL

15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Infant I-3

15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Intervention Type: BIOLOGICAL

15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Interventions

Inactivated Poliomyelitis Vaccine (Sabin strains)

15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Intervention Type: BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Intervention Type: BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Intervention Type: BIOLOGICAL

Other Intervention Names

Sabin IPV,lot No.20080303; Sabin IPV, lot No.20080302; Sabin IPV, lot No.20080301

Eligibility Criteria

Inclusion Criteria

• Males and females, age from 60 days to 60 years old;
• Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
• Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
• Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
• Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
• Axillary temperature ≤37℃.

Exclusion Criteria

• Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
• Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
• Low platelet or bleeding disorder do not allow vaccination into the muscle;
• Have damaged or lower immunological function;
• Received blood, plasma or immunoglobulin treatment since birth;
• Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ).

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

OTHER_GOV

Sponsor Role: collaborator

National Institute for the Control of Pharmaceutical and Biological Products, China

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Institute of Medical Biology, Chinese Academy of Medical Sciences

Principal Investigators

Liao Guoyang, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Biology, Chinese Academy of Medical Sciences

Li Rongcheng, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Li Changgui, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute for the Control of Pharmaceutical and Biological Products, China

Locations

Hezhou Center for Disease Prevention and Control

Hezhou, Guangxi, China

Countries

China

Other Identifiers

SFDA2007L02021

Identifier Type: OTHER

Identifier Source: secondary_id

imbcams-01

Identifier Type: -

Identifier Source: org_study_id