the Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChina National Biotec Group Company Limited
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None.
Trial population
Participants who have taken part in the NCT04638985 or NCT04636827 trials and have completed the designated batches of sIPV, MMR or HepA-L vaccinations, with a time interval of 60 to 66 months since the fourth dose of sIPV, the second dose of MMR or the first dose of HepA-L vaccination at the time of enrollment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: 5 years of follow-up group
Trial outcomes
Primary outcomes
1
seropositive rates of antibodies against poliovirus
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization.
Time frame
5 years after the four doses of sIPV immunization2
seropositive rates of antibodies against measles, rubella, mumps
The percentage of participants with positive antibody against measles, rubella, mumps 5 years after the two doses of MMR immunization.
Time frame
5 years after the two doses of MMR immunization3
seropositive rates of antibodies against hepatitis A
The percentage of participants with positive antibody against hepatitis A 5 years after the one doses of HepA-L immunization.
Time frame
5 years after the one doses of HepA-L immunizationSecondary outcomes
1
GMTs of antibodies against poliovirus
The GMTs of participants against all three serotypes of poliovirus 5 years after the four doses of sIPV immunization.
Time frame
5 years after the four doses of sIPV immunization2
GMCs of antibodies against measles, rubella, mumps
The GMCs of participants against measles, rubella, mumps 5 years after the two doses of MMR immunization.
Time frame
5 years after the two doses of MMR immunization3
GMCs of antibodies against hepatitis A
The GMCs of participants against hepatitis A 5 years after the one doses of HepA-L immunization.
Time frame
5 years after the one doses of HepA-L immunizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
China National Biotec Group Company Limited
Lead sponsor
Shaanxi Provincial Center for Disease Control and Prevention
Collaborator
Hubei Provincial Center for Disease Control and Prevention
Collaborator
Jiangsu Province Centers for Disease Control and Prevention
Collaborator
Anhui Provincial Center for Disease Control and Prevention
Collaborator
Sichuan Provincial Center for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov
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