ema-adama
28-02-10, 03:45 PM
14.6 Immunogenicity
A relationship between antibody responses to RotaTeq and protection against rotavirus gastroenteritis has not been established. In phase 3 studies, 92.9% to 100% of 439 recipients of RotaTeq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0%of 397 placebo recipients.From the product insert (http://www.google.co.il/url?sa=t&source=web&ct=res&cd=1&ved=0CAYQFjAA&url=https%3A%2F%2Fwww.merck.com%2Fproduct%2Fusa%2F pi_circulars%2Fr%2Frotateq%2Frotateq_pi.pdf&rct=j&q=a+relationship+between+antibody+responses+to+Rot aTeq+against+rotavirus+gastroenteritis+has+not+bee n+established&ei=cwGKS4D3LpL00gTSnuXHCw&usg=AFQjCNHgUZxPpzA_sLqDZ-laCaBF92IyDw&sig2=np3A5Ueqn0bYhbATUy7OCg)
Bolding mine.
Is this relevant? Do the numbers that follow not indicate that in the study sample the vaccine is working? Admittedly, 836 babies is hardly a large study when it comes to making claims for the vaccine for millions of children.
I have not read much about this vaccine, so I have no idea if there have been more substantial studies done or not.
ETA: please fix the title for me by dropping the 'a'. Thanks
A relationship between antibody responses to RotaTeq and protection against rotavirus gastroenteritis has not been established. In phase 3 studies, 92.9% to 100% of 439 recipients of RotaTeq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0%of 397 placebo recipients.From the product insert (http://www.google.co.il/url?sa=t&source=web&ct=res&cd=1&ved=0CAYQFjAA&url=https%3A%2F%2Fwww.merck.com%2Fproduct%2Fusa%2F pi_circulars%2Fr%2Frotateq%2Frotateq_pi.pdf&rct=j&q=a+relationship+between+antibody+responses+to+Rot aTeq+against+rotavirus+gastroenteritis+has+not+bee n+established&ei=cwGKS4D3LpL00gTSnuXHCw&usg=AFQjCNHgUZxPpzA_sLqDZ-laCaBF92IyDw&sig2=np3A5Ueqn0bYhbATUy7OCg)
Bolding mine.
Is this relevant? Do the numbers that follow not indicate that in the study sample the vaccine is working? Admittedly, 836 babies is hardly a large study when it comes to making claims for the vaccine for millions of children.
I have not read much about this vaccine, so I have no idea if there have been more substantial studies done or not.
ETA: please fix the title for me by dropping the 'a'. Thanks