The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)
This study has been completed.
Sponsor:
Chinese Academy of Medical Sciences
Collaborators:
Guangxi Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Information provided by:
Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01048190
First received: January 12, 2010
Last updated: January 13, 2010
Last verified: August 2008
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Purpose
The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
| Condition | Intervention | Phase |
|---|---|---|
|
Poliomyelitis |
Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains |
Resource links provided by NLM:
Further study details as provided by Chinese Academy of Medical Sciences:
Primary Outcome Measures:
- To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 130 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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;
|
Biological: 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.
Other Name: Sabin IPV,lot No.20080303
|
|
Experimental: 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;
|
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;
Other Name: Sabin IPV, lot No.20080302
|
|
Experimental: 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.
|
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.
Other Name: Sabin IPV, lot No.20080301
|
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.
Eligibility| Ages Eligible for Study: | 60 Days to 90 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 ).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048190
Locations
| China, Guangxi | |
| Hezhou Center for Disease Prevention and Control | |
| He Zhou, Guangxi, China, 542800 | |
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Guangxi Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Investigators
| Principal Investigator: | Liao Guoyang, PhD | Institute of Medical Biology, Chinese Academy of Medical Sciences |
| Principal Investigator: | Li Rongcheng, MD | Guangxi Center for Disease Prevention and Control |
| Principal Investigator: | Li Changgui, PhD | National Institute for the Control of Pharmaceutical and Biological Products, China |
More Information
Additional Information:
No publications provided
| Responsible Party: | Liao Guoyang, PhD, Institute of Medical Biology, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01048190 History of Changes |
| Other Study ID Numbers: | imbcams-01, SFDA2007L02021 |
| Study First Received: | January 12, 2010 |
| Last Updated: | January 13, 2010 |
| Health Authority: | United States: Food and Drug Administration China: Food and Drug Administration |
Keywords provided by Chinese Academy of Medical Sciences:
|
Inactivated Poliomyelitis Vaccine Sabin Strains poliomyelitis |
Additional relevant MeSH terms:
|
Poliomyelitis Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013