Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Nanjing, Jiangsu, 210009, China
NCT Number: NCT06442449
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.
Looking for future studies?
Notify Me18 month–22 month
All sexes
Interventional
Phase 4
Nanjing, Jiangsu, 210009, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
vaccination with sIPV
vaccination with MMR
vaccination with HepA-I
Time frame: 30 days
-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-measles IgG antibodies 30 days after vaccination
Time frame: 30 days
SCRs of anti-mumps IgG antibodies 30 days after vaccination
Time frame: 30 days
SCRs of anti-rubella IgG antibodies 30 days after vaccination
Time frame: 30 days
SCRs of anti-hepatitis A antibodies 30 days after vaccination
Time frame: 30 days
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 30 days after vaccination;
Time frame: 30 days
SPRs and GMC of anti-rubella virus IgG antibodies 30 days after vaccination;
Time frame: 30 days
SPRs and GMC of anti- hepatitis A virus IgG antibodies 30 days after vaccination;
Time frame: 30 days
-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
Time frame: 30 days
Time frame: 30 days
Sinovac Biotech Co., Ltd
Industry
Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07073144
Behavior, Behavioral Symptoms
Hong Kong
View Trial DetailsNCT03891758
Actinomycetales Infections, Bacterial Infections
Fukuoka, Japan
View Trial DetailsNCT07297186
Central Nervous System Diseases, Central Nervous System Infections
Nanjing, Jiangsu, China
View Trial DetailsNCT05850364
Central Nervous System Diseases, Central Nervous System Infections
Dhaka, Bangladesh
View Trial Details