The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.
This study is an open and observational phase Ⅳ clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.A total of 3200 subjects including 2000 subjects aged 2\~3 months in primary immunization group,1200 subjects aged 18 months in primary immunization group will be enrolled and will receive sIPV vaccine or sIPV vaccine and other vaccines simultaneously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,200
All subjects received 3 doses of sIPV vaccines and 3 doses of DTaP vaccines. Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.
All subjects will receive 1 dose of sIPV and 2 doses of hepatitis A inactivated vaccine/or 1 dose of attenuated hepatitis A vaccine and 1 dose of MMR vaccine.Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.
Gaoan Center for Disease Control and Prevention
Gao’an, Jiangxi, China
Shangli County Center for Disease Control and Prevention
Pingxiang, Jiangxi, China
Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine
Incidence of adverse reactions within 0\~7 days after primary immunization of sIPV vaccine
Time frame: Within 0~7 days after primary immunization
Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine
Incidence of adverse reactions within 0\~30 days after primary immunization of sIPV vaccine.
Time frame: Within 0~30 days after primary immunization
Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine
Incidence of adverse reactions within 0\~7 days after booster immunization of sIPV vaccine .
Time frame: Within 0~7 days after booster immunization
Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine
Incidence of adverse reactions within 0\~30 days after booster immunization of sIPV vaccine.
Time frame: Within 0~30 days after booster immunization
Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine
Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine.
Time frame: Within 0-7 days after primary immunization combined with DTaP vaccine
Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine
Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine combined with DTaP vaccine.
Time frame: Within 0-30 days after primary immunization combined with DTaP vaccine
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Incidence of adverse reactions after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine
Incidence of adverse reactions within 0\~7 days after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine.
Time frame: Within 0~7 days after booster immunization combined with inactivated hepatitis A vaccine
Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine
Incidence of adverse reactions within 0 \~14 days after booster immunization of sIPV vaccine combined with MMR vaccine or attenuated hepatitis A vaccine.
Time frame: Within 0 ~14 days after booster immunization
Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine
Incidence of adverse events within 0 \~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.
Time frame: Within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.