close

Вход

Забыли?

вход по аккаунту

?

VRBPAC January 25, 2007 - Food and Drug Administration

код для вставкиСкачать
VRBPAC
Pentacel
Theresa Finn, Ph.D
OVRR, CBER
January 25, 2007
Pentacel (DTaP-IPV/Hib)
• DTaP-IPV used to reconstitute Hib (PRP-T)
• DTaP-IPV/Hib
• 2, 4, 6 and 15-18 months of age
VRBPAC
• Safety
• Efficacy (Immunogenicity):
– D, T, polio: protective levels post-dose 3
– Hib: protective levels and GMC post-dose 3
– Pertussis:
• Serology bridge to DAPTACEL (DTaP) in Sweden I
efficacy trial
• Comparison to DAPTACEL (DTaP) in a U.S. study
Questions and Discussion Items
1.
Are the available data adequate to support the safety of
four doses of Pentacel administered at 2, 4, 6 and 1518 months of age?
(Voting Item)
If the available data are not adequate, what additional
data are needed?
Questions and Discussion Items
cont’d.
2.
Please discuss whether the available data are
adequate to support the efficacy of:
a) The diphtheria, tetanus and polio components of
Pentacel,
b) The Hib (PRP-T) component of Pentacel, and
c) The pertussis component of Pentacel.
Are the available data adequate to support the efficacy
of Pentacel?
(Voting Item)
If the available data are not adequate, what additional
data are needed?
Questions and Discussion Items
cont’d.
3.
If Pentacel is licensed, please identify
any issues which should be addressed in
post-licensure studies.
Документ
Категория
Презентации
Просмотров
0
Размер файла
31 Кб
Теги
1/--страниц
Пожаловаться на содержимое документа