Corrections to Errata in the
FDA Clinical Briefing Document
March 10, 2005
ChrisAnna M. Mink M.D.
1. Page 8, Table 2.1:
The criteria for the endpoints for each of the pertussis antigens have
been corrected from 90% CI ratio to 95% CI ratio Tdap/Sweden I > 0.67,
with the revision shown in bold.
Table 2.1. Summary of Study Td506
Endpoints
|
Antigen |
Endpoint |
Criteria |
|
Diphtheria |
% booster %
³0.1 IU/ml |
95%
CI δ < 10% 95% CI δ < 10% |
|
Tetanus |
% booster % ³0.1 IU/mL |
95% CI δ < 10% 95% CI δ < 10% |
|
PT |
GMC % booster*
|
95% CI ratio Tdap/Sweden I ³ 0.67 95% CI > 80.8% (85 EU/ml) |
|
FHA |
GMC % booster* |
95% CI ratio Tdap/Sweden I ³ 0.67 95% CI > 79.5% (170 EU/ml) |
|
Pertactin |
GMC % booster* |
95% CI ratio Tdap/Sweden 1 ³ 0.67 95% CI > 86.2% (115 EU/ml) |
|
Fim |
GMC % booster*
|
95% CI ratio Tdap/Sweden 1 ³0.67 95% CI > 81.7% (285 EU/ml) |
|
Safety |
Erythema, swelling, pain and fever |
95%
CI δ < 10% |
*Booster response = 4-fold rise for values below and 2-fold rise for
values above the pre-defined cutoff levels (for diphtheria: cut-off value = 2.56 IU/ml and for tetanus
cut-off value =2.7 IU/ml)
2. Page 9, Laboratory Methods ¶, 3rd
line: The sentence has been corrected
as follows:
2.1. Strike through:
Seroneutralization assays were performed for dip antibodies (IUs/ml) and
ELISA for tetanus antibodies with values in EUs/ml converted to
IUs/ml.
2.2. Revised:
Seroneutralization assays were performed for dip antibodies (IUs/ml) and
ELISA for tetanus antibodies with values in IUs/ml.
3. Page 19, Section 4.3.6 Serious Adverse Events, 3rd
¶: The 1st sentence has been corrected as follows:
3.1. Strike through:
Three seizure events reported, two in adolescent male Tdap recipients
with pre-existing histories of seizure disorders and one seizure event that
occurred 22 days after Tdap in a 55 year old female with a history of migraines
and hypertension.
3.2. Revised: Three
seizure events reported, two in adolescent males (one Tdap recipient and one Td
recipient) with pre-existing histories of seizure disorders and one seizure
event that occurred 22 days after Tdap in a 55 year old female with a history
of migraines and hypertension.
4. Page 43, Section 25, 2nd ¶: The percent of subjects in the separate administration
study group with sore/swollen joints has been revised from 12% to 18%, as
follows:
4.1. Strike through:
Of note, reports of swollen and/or sore joints were frequent (~22% for
concomitant vaccination and ~1218% for separate administration) and appeared
more frequent in this trial compared to the others in the BLA.
4.2. Revised: Of
note, reports of swollen and/or sore joints were frequent (~22% for concomitant
vaccination and ~18% for separate administration) and appeared more frequent in
this trial compared to the others in the BLA