Hepatitis A, Measles, Mumps, Polio, Rubella
Conditions
Brief summary
This study evaluated the antibody persistence of Chinese children five years after they received four doses of sIPV, two doses of MMR vaccine and one dose of HepA-L vaccine.
Detailed description
This is a follow-up study of several previous clinical trials (A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR) : NCT04054882, NCT04638985; A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA): NCT04053010, NCT04636827). Five years after vaccination with sIPV, MMR or HepA-L, blood samples were collected from the followed-up children to assess the antibody levels and seropositive rates against polio, measles, rubella, mumps and hepatitis A. This study was conducted in six provinces of China.
Interventions
None listed
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Hubei Provincial Center for Disease Control and Prevention
Jiangsu Provincial Center for Disease Control and Prevention
Anhui Provincial Center for Disease Control and Prevention
Sichuan Provincial Center for Disease Control and Prevention
China National Biotec Group Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Participants in the NCT04638985 or NCT04636827, and who have completed the vaccination of designated batch numbers of sIPV, MMR or HepA-L vaccines; * The time window from the day of enrollment to the date when the participants received the fourth dose of sIPV vaccine, the second dose of MMR vaccine, or the first dose of HepA-L vaccine was 60 to 66 months. * The informed consent form shall be signed by the participant or his/her legal guardian and dated.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seropositive rates of antibodies against poliovirus | 5 years after the four doses of sIPV immunization | The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization. |
| seropositive rates of antibodies against measles, rubella, mumps | 5 years after the two doses of MMR immunization | The percentage of participants with positive antibody against measles, rubella, mumps 5 years after the two doses of MMR immunization. |
| seropositive rates of antibodies against hepatitis A | 5 years after the one doses of HepA-L immunization | The percentage of participants with positive antibody against hepatitis A 5 years after the one doses of HepA-L immunization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of antibodies against poliovirus | 5 years after the four doses of sIPV immunization | The GMTs of participants against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization. |
| GMCs of antibodies against measles, rubella, mumps | 5 years after the two doses of MMR immunization | The GMCs of participants against measles, rubella, mumps 5 years after the two doses of MMR immunization. |
| GMCs of antibodies against hepatitis A | 5 years after the one doses of HepA-L immunization | The GMCs of participants against hepatitis A 5 years after the one doses of HepA-L immunization. |
Countries
China
Contacts
Primary ContactWeijun Hu
Outcome results
None listed