Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers⦠(NCT05252715) | Clinical Trial Compass
UnknownPhase 3
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months
China1,200 participantsStarted 2021-12-18
Plain-language summary
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months.
Who can participate
Age range3 Months ā 5 Months
SexALL
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Inclusion Criteria:
For primary vaccination
* Subjects aged 3-5 months;
* Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ⤠body weight ⤠4000g);
* Axillary body temperature ⤠37.0 ā;
* The guardian signs the informed consent form;
* The guardian and his family agree to comply with the requirements of the clinical trial protocol;
* Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine at the aged of 3-5 months;
* Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
For booster vaccination
* Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
* The guardian and his family agree to comply with the requirements of the clinical trial protocol.
Exclusion Criteria:
For primary vaccination
* Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
* History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
* A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
* History of Abnormal production process, asphyxia rescue, or congenital malformation, serious developmental disorder, serious genetic defect, seriousā¦
What they're measuring
1
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate