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Showing 1-7 of 7 trials
NCT04440176
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.
NCT07505836
The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.
NCT07505823
The goal of this clinical trial is to evaluate the immunogenicity, safety, and persistence of the immune response of a group ACYW135 meningococcal conjugate vaccine in healthy children aged 6 to 11 months. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine following the primary series? What is the safety profile of the investigational vaccine during the primary series and booster dose? Does the investigational vaccine provide durable immune persistence up to 18 months of age? What is the immunogenicity of a booster dose administered at 18 months of age? Researchers will compare the investigational vaccine group with the active comparator group (licensed group ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO) during the primary immunization phase. Only the investigational group will receive a booster dose at 18 months of age to evaluate booster immunogenicity and safety. Participants will: Be randomly assigned in a 1:1 ratio to receive either two doses of the investigational vaccine or two doses of the control vaccine according to a 0,1-month schedule during the primary immunization phase; In the investigational group only, receive a booster dose at 18 months of age; Provide blood samples at three time points: before primary vaccination, 30 days after primary vaccination, and at 18 months of age to assess primary immunogenicity and immune persistence; In the investigational group only, provide an additional blood sample 30 days after the booster dose to assess booster immunogenicity; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after the last dose administered; A total of 1040 participants will be enrolled.
NCT04819113
This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants \<6 months of age, followed by the booster at 12 months
NCT01266993
The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®. This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)
NCT03263403
This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Quadri Meningo on a total of 88 healthy adult participants (18-45 years of age). 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Quadri Meningo which is produced by BiO-MeD Private Limited. Vaccination will be done in Day 0 following the screening and pre-immunization blood sample collection and post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior and immunogenic among adults in Bangladesh as compared to Quadri Meningo.
NCT01830855
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.