The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)
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| ClinicalTrials.gov Identifier: NCT01048190 |
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Recruitment Status :
Completed
First Posted : January 13, 2010
Last Update Posted : January 14, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Poliomyelitis | Biological: Inactivated Poliomyelitis Vaccine (Sabin strains) | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
| Arm | Intervention/treatment |
|---|---|
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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;
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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 |
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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;
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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 |
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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.
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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 |
- To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ]
- To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does. [ Time Frame: one year ]
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| Ages Eligible for Study: | 60 Days to 90 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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 ).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048190
| China, Guangxi | |
| Hezhou Center for Disease Prevention and Control | |
| He Zhou, Guangxi, China, 542800 | |
| Principal Investigator: | Liao Guoyang, PhD | Chinese Academy of Medical Sciences | |
| Principal Investigator: | Li Rongcheng, MD | Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control | |
| Principal Investigator: | Li Changgui, PhD | National Institute for the Control of Pharmaceutical and Biological Products, China |
| Responsible Party: | Liao Guoyang, PhD, Institute of Medical Biology, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01048190 |
| Other Study ID Numbers: |
imbcams-01 SFDA2007L02021 ( Other Identifier: China state food and drug adminstration ) |
| First Posted: | January 13, 2010 Key Record Dates |
| Last Update Posted: | January 14, 2010 |
| Last Verified: | August 2008 |
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Inactivated Poliomyelitis Vaccine Sabin Strains poliomyelitis |
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Poliomyelitis Myelitis Central Nervous System Infections Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases |
Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |