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

% 0.1 IU/ml

95% CI δ < 10%

95% CI δ < 10%

Tetanus

% booster

% 0.1 IU/mL

95% CI δ < 10%

95% CI δ < 10%

PT

GMC

% booster*

 

95% CI ratio Tdap/Sweden I 0.67

95% CI > 80.8%

(85 EU/ml)

FHA

GMC

% booster*

95% CI ratio Tdap/Sweden I 0.67

95% CI > 79.5%

(170 EU/ml)

Pertactin

GMC

% booster*

95% CI ratio Tdap/Sweden 1 0.67

95% CI > 86.2%

(115 EU/ml)

Fim

GMC

% booster*

 

95% CI ratio Tdap/Sweden 1 0.67

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