Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Pop… (NCT04236960) | Clinical Trial Compass
CompletedPhase 1
Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
China100 participantsStarted 2018-07-17
Plain-language summary
A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.
Who can participate
Age range2 Months – 55 Years
SexALL
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Inclusion Criteria:
* Healthy children, adolescents and adults (age range: 2 months to 55 years old) based on medical history, physical examination or judgement of the investigator
* Subjects aged ≥18 years old voluntarily agree to participate in this clinical study and sign the informed consent form; or for subjects aged \<18 years old, the legal guardian voluntarily agrees that his/her child to participate in this clinical study, and sign the informed consent form. For juveniles aged ≥8 years old, both the subject and his/her legal guardians should voluntarily agree to participate in this clinical study and sign the informed consent form.
* The subject and his/her legal guardians as well as the family members are able to follow the request of clinical study protocol.
* Subjects aged 2 or 3 months should have no vaccination history of any meningococcal vaccine; subjects aged 7\~23 months should have not received any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in National Immunization Program, and the time since last vaccination of meningococcal group A polysaccharide vaccine should be \>6 months; for subjects ≥2 years, the time since last vaccination of meningococcal vaccine should be \>2 years.
* For subjects aged ≥2 years, there should be no clinically significant abnormal hematology, liver and renal function results judged by the investigator before immunization.
* Subjects should not receive any attenuated live vaccine 14…
What they're measuring
1
Incidence of adverse events after each vaccination