A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine...
Meningococcal MeningitisHuman Papillomavirus Infection2 moreThis study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers...
Meningococcal MeningitisMeasles3 moreThis is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. Observational Objectives: Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups. Immunogenicity: - To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants...
MeningitisMeningococcalThis study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy...
Meningococcal MeningitisMeasles3 moreThis clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.
High and Low Resource Interventions to Promote HPV Vaccines
Human Papilloma VirusTdap - Tetanus5 moreHuman Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile cancers as well as genital warts.The purpose of this study is to test the comparative effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic settings. Providers and staff at four pediatric practices will be randomized to receive an in-person AFIX consultation or an AFIX consultation combined with communication training and commitment poster displays. Provider and parent data will be collected via a tablet computer RedCap survey. Additional practice and provider level HPV vaccination rates will be collected via patient de-identified claims data. The results of this study could contribute to the existing body of literature that suggests provider recommendations and routine vaccination assessments are key to increasing HPV vaccination uptake. This project has the potential to lead to the implementation and dissemination of low resource interventions to increase HPV vaccination rates among children and adolescents.
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
MeningitisMeningococcalThe purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
MeningitisMeningococcalThe purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which serves for the development, qualification, validation, and maintenance of immunological assays which supports the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the two vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during their participation in the study.
Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018
MeningitisMeningococcalThe trial is an interventional, cluster-randomized trial to assess the impact of oral ciprofloxacin for household and community contacts of meningitis cases on the incidence of meningitis during an epidemic. The trial contains a nested sub-study ("resistance study") to assess the effect of a single dose of ciprofloxacin on the prevalence of fluoroquinolone-resistant enterobacteriaceae in the study area.
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Meningococcal DiseaseMeningococcal MeningitisThe primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate...
Meningococcal MeningitisThe primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).