Poliomyelitis
Conditions
Keywords
Inactivated Poliomyelitis Vaccine, Sabin Strains, poliomyelitis
Brief summary
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Detailed description
The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose. Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU. This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.
Interventions
Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
BIOLOGICALInactivated Poliomyelitis Vaccine (Salk strains)
Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
Sponsors
Guangxi Center for Disease Control and Prevention
National Institute for the Control of Pharmaceutical and Biological Products, China
Institute of Medical Biology, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Males and females, age from 60 days to 90 days; * 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; * 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 ); * Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants | fours year | Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants | One year | Comparison of geometric mean titers (GMTs) of Sabin IPV and Salk IPV after three doses of vaccination |
| Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV | 30-60 days after third dose immunization | One dose of tOPV was given after one month of third dose of IPV. The stool specimens were obtained at 0, 7, 14, 21, 28 days after OPV challenge. And determine the excretion rates of polioviruses. |
Countries
China
Outcome results
None listed