A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults
详细信息 查看全文
- 作者：Lars Ostergaarda ; larsoest@rm.dk" class="auth_mail" title="E-mail the corresponding author ; Gregg H. Lucksingerb ; glucksinger@tektonresearch.com" class="auth_mail" title="E-mail the corresponding author ; Judith Absalonc ; Judith.Absalon@pfizer.com" class="auth_mail" title="E-mail the corresponding author ; Johannes Beeslaard ; johannes.beeslaar@pfizer.com" class="auth_mail" title="E-mail the corresponding author ; Joseph Eidenc ; joseph.eiden@pfizer.com" class="auth_mail" title="E-mail the corresponding author ; Kathrin U. Jansenc ; kathrin.jansen@pfizer.com" class="auth_mail" title="E-mail the corresponding author ; Laura J. Yorke ; laura.york@pfizer.com" class="auth_mail" title="E-mail the corresponding author ; Angela Quinnc ; angela.quinn@pfizer.com" class="auth_mail" title="E-mail the corresponding author ; Mette E. Graversena ; metgrave@rm.dk" class="auth_mail" title="E-mail the corresponding author ; John L. Perezf ; john.perez@pfizer.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：AE ; adverse event ; fHBP ; factor H binding protein ; HAV ; hepatitis A virus vaccine ; IMD ; invasive meningococcal disease ; MAE ; medically-attended adverse event ; MnB ; Neisseria meningitidis serogroup B ; NDCMC ; newly-diagnosed chronic medical condition ; SAE ; serious adverse event
- 刊名：Vaccine
- 出版年：2016
- 出版时间：14 March 2016
- 年：2016
- 卷：34
- 期：12
- 页码：1465-1471
- 全文大小：477 K
文摘
- class="listitem" id="list_lis0005">
- class="label">•
Largest controlled safety study of a recombinant meningococcal serogroup B vaccine.
- class="label">•
SAEs occurred in lower percentage of bivalent rLP2086 group than control group.
- class="label">•
SAEs related to vaccine were rare.
- class="label">•
Rates of medically-attended AEs were similar between vaccine groups.
- class="label">•
Bivalent rLP2086 was safe and tolerable in adolescents and young adults 10–25 years.