Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452464
Other study ID # V59_34OB
Secondary ID
Status Completed
Phase N/A
First received September 29, 2011
Last updated February 25, 2015
Start date September 2011
Est. completion date February 2015

Study information

Verified date February 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.


Description:

This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.

Events of interest: Seizure, Aseptic meningitis, Bell's Palsy, Multiple Sclerosis, Guillain-Barre Syndrome, Acute disseminated encephalomyelitis, Cerebellar ataxia, Transverse myelitis, Brachial Neuritis, Hashimoto's disease, Systemic Lupus Erythematosis, Henoch Schonlein Purpura, New Onset Juvenile Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Suicide attempt.


Recruitment information / eligibility

Status Completed
Enrollment 55397
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 21 Years
Eligibility Inclusion Criteria:

1. Enrolled in the HMO for at least 6 months prior to vaccination

2. Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination.

3. Received the vaccine during the study period

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
MenACWY-CRM
MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.

Locations

Country Name City State
United States Riverside Medical Center Campus, 10800 Magnolia Ave Riverside California
United States San Diego Medical Center Campus, 4647 Zion Ave 92120 San Diego California
United States Fontana Medical Center Campus Valley Annex, 16994 E. Valley Blvd., Fontana California

Sponsors (2)

Lead Sponsor Collaborator
Novartis Vaccines Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relative incidence (RI) for an Event of Interest (EOI) is calculated using the self controlled case series method. RI is the ratio of the incidence of an EOI in a pre-specified, event-specific risk window relative to the incidence in the control period. Observational period of 1 year following date of vaccination of that individual. No
Secondary Frequency (n,%) of each EOI is calculated. Observational period of 1 year following date of vaccination of that individual. No
Secondary Incidence (n/person yrs) of each EOI is calculated. Observational period of 1 year following date of vaccination of that individual. No
See also
  Status Clinical Trial Phase
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Completed NCT01434680 - Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers Phase 2
Completed NCT01452438 - Safety Surveillance of MenACWY-CRM Vaccine in Children N/A
Completed NCT02173704 - Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan. Phase 3
Completed NCT01682876 - Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age. Phase 3
Recruiting NCT04023929 - Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT01214837 - Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life Phase 3
Completed NCT03378258 - Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
Recruiting NCT04239430 - Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study
Completed NCT01994629 - Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers Phase 2
Completed NCT01973218 - Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years. Phase 3
Completed NCT01725217 - Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia Phase 3
Completed NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 Phase 3
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT01000311 - A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months Phase 3
Completed NCT02140762 - Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents Phase 2
Completed NCT02141516 - Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects Phase 3
Completed NCT01823536 - Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose Phase 4
Completed NCT01478347 - A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults Phase 3