Poliomyelitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALsIPV vaccine /DTaP vaccine
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.
BIOLOGICALsIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine
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.
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants aged 2-3 months should be involved in primary immunization and they have not received Sabin strain inactivated polio vaccine (Vero Cell) in the past; * Children aged 18 months should be immunized with the first three doses of Sabin strain inactivated polio vaccine (Vero Cell) and they have not received any inactivated or attenuated live vaccines in the past 14 days; * The guardian agrees to sign the informed consent and voluntarily use the mobile APP to participate in the follow-up visits.
Exclusion criteria
* Allergic to the active ingredient in the vaccine, any inactive ingredient, or substance used in the manufacturing process; * Allergic to this product or similar vaccines in the past; * Patients with severe chronic diseases or allergies; * Patients with fever or acute illness. The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine | Within 0~7 days after primary immunization | Incidence of adverse reactions within 0\ 7 days after primary immunization of sIPV vaccine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine | Within 0~7 days after booster immunization | Incidence of adverse reactions within 0\ 7 days after booster immunization of sIPV vaccine . |
| Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine | Within 0~30 days after booster immunization | Incidence of adverse reactions within 0\ 30 days after booster immunization of sIPV vaccine. |
| Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine | Within 0-7 days after primary immunization combined with DTaP vaccine | Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine. |
| Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine | Within 0~30 days after primary immunization | Incidence of adverse reactions within 0\ 30 days after primary immunization of sIPV vaccine. |
| Incidence of adverse reactions after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine | Within 0~7 days after booster immunization 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. |
| Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine | Within 0 ~14 days after booster immunization | Incidence of adverse reactions within 0 \ 14 days after booster immunization of sIPV vaccine combined with MMR vaccine or attenuated hepatitis A vaccine. |
| Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine | Within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A 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. |
| Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine | Within 0-30 days after primary immunization combined with DTaP vaccine | Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine combined with DTaP vaccine. |
Countries
China
Outcome results
None listed