Safety of MenACWY-CRM Vaccination in Adolescents
Kľúčové slová
Abstrakt
Popis
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.
Termíny
| Naposledy overené: | 01/31/2015 |
| Prvý príspevok: | 09/28/2011 |
| Odhadovaná registrácia bola odoslaná: | 10/12/2011 |
| Prvý príspevok: | 10/13/2011 |
| Posledná aktualizácia bola odoslaná: | 02/24/2015 |
| Posledná aktualizácia bola zverejnená: | 02/25/2015 |
| Aktuálny dátum začatia štúdie: | 08/31/2011 |
| Odhadovaný dátum dokončenia primárneho okruhu: | 01/31/2015 |
| Odhadovaný dátum dokončenia štúdie: | 01/31/2015 |
Stav alebo choroba
Intervencia / liečba
Biological: MenACYW-CRM vaccinated adolescents
Fáza
Skupiny zbraní
| Arm | Intervencia / liečba |
|---|---|
| MenACYW-CRM vaccinated adolescents All adolescent recipients of MenACYW-CRM vaccines during the study period. Among these, adolescents who have additionally experienced an event of interest within the 1-year observation period following vaccination will be included in the self-controlled case series. | Biological: MenACYW-CRM vaccinated adolescents MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records. |
Kritériá oprávnenosti
| Vek vhodný na štúdium | 11 Years To 11 Years |
| Pohlavia vhodné na štúdium | All |
| Metóda vzorkovania | Non-Probability Sample |
| Prijíma zdravých dobrovoľníkov | Áno |
| Kritériá | 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: |
Výsledok
Primárne výstupné opatrenia
1. 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.]
Opatrenia sekundárnych výsledkov
1. Frequency (n,%) of each EOI is calculated. [Observational period of 1 year following date of vaccination of that individual.]
2. Incidence (n/person yrs) of each EOI is calculated. [Observational period of 1 year following date of vaccination of that individual.]
