This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.
The trial plans to enroll 960 infants aged 18 months (+4 months) who had completed three primary doses of sIPV vaccine and were assigned in a 2:2:2:1:1 ratio to four groups including trial group 1, trial group 2, control group 1, control group 2, control group 2, with informed consent from the participant's guardian. Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine. Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine. Control group 1 receive one dose of sIPV, control group 2 receive one dose of MMR vaccine, and control group 3 receive one dose of inactivated hepatitis A vaccine. About 3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection. Immediate reactions will be observed for 30 minutes after vaccination, and adverse events occured from 0 to day 30 after vaccination will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
889
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Nanjing, Jiangsu, China
seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
-The SCRs of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination.
Time frame: 30 days
SCRs of anti-meascles IgG antibodies
SCRs of anti-measles IgG antibodies 30 days after vaccination
Time frame: 30 days
SCRs of anti-mumps IgG antibodies
SCRs of anti-mumps IgG antibodies 30 days after vaccination
Time frame: 30 days
SCRs of anti-rubella IgG antibodies
SCRs of anti-rubella IgG antibodies 30 days after vaccination
Time frame: 30 days
SCRs of anti-hepatitis A IgG antibodies
SCRs of anti-hepatitis A antibodies 30 days after vaccination
Time frame: 30 days
Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies
SPRs and GMC of anti-measles virus IgG antibodies 30 days after vaccination.
Time frame: 30 days
SPRs and GMC of anti-mumps virus IgG antibodies
SPRs and GMC of anti-mumps virus IgG antibodies 30 days after vaccination;
Time frame: 30 days
SPRs and GMC of anti-rubella virus IgG antibodies
SPRs and GMC of anti-rubella virus IgG antibodies 30 days after vaccination;
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Time frame: 30 days
SPRs and GMC of anti- hepatitis A virus IgG antibodies
SPRs and GMC of anti- hepatitis A virus IgG antibodies 30 days after vaccination;
Time frame: 30 days
Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III)
-GMTs of antibody of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination;
Time frame: 30 days
- SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III)
\- SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III) at day 30 after vaccination.
Time frame: 30 days
- Incidence of adverse reactions (ARs)
\- Incidence of ARs from 0 to 30 days after vaccination;
Time frame: 30 days
- Incidence of serious adverse events (SAEs)
\- Incidence of SAEs 0\~30 days after vaccination.
Time frame: 30 days