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 [\>]{.underline} 0.67, with the revision shown
    in **bold**.

Table 2.1. Summary of Study Td506 Endpoints

+---------------+-----------------------+-----------------------------+
| **Antigen**   | **Endpoint**          | **Criteria**                |
+---------------+-----------------------+-----------------------------+
| *             | \% booster            | 95% CI δ \< 10%             |
| *Diphtheria** |                       |                             |
|               | > \% 0.1 IU/ml        | 95% CI δ \< 10%             |
+---------------+-----------------------+-----------------------------+
| **Tetanus**   | \% booster            | 95% CI δ \< 10%             |
|               |                       |                             |
|               | \% 0.1 IU/mL          | 95% CI δ \< 10%             |
+---------------+-----------------------+-----------------------------+
| **PT**        | GMC                   | **95**% CI ratio            |
|               |                       | Tdap/Sweden I 0.67          |
|               | ## % booster\*        |                             |
|               |                       | 95% CI \> 80.8%             |
|               | ##                    |                             |
|               |                       | (85 EU/ml)                  |
+---------------+-----------------------+-----------------------------+
| **FHA**       | GMC                   | **95**% CI ratio            |
|               |                       | Tdap/Sweden I 0.67          |
|               | \% booster\*          |                             |
|               |                       | 95% CI \> 79.5%             |
|               |                       |                             |
|               |                       | (170 EU/ml)                 |
+---------------+-----------------------+-----------------------------+
| **Pertactin** | GMC                   | **95**% CI ratio            |
|               |                       | Tdap/Sweden 1 0.67          |
|               | \% booster\*          |                             |
|               |                       | 95% CI \> 86.2%             |
|               |                       |                             |
|               |                       | (115 EU/ml)                 |
+---------------+-----------------------+-----------------------------+
| **Fim**       | GMC                   | **95**% CI ratio            |
|               |                       | Tdap/Sweden 1 0.67          |
|               | ## % booster\*        |                             |
|               |                       | 95% CI \> 81.7%             |
|               |                       |                             |
|               |                       | (285 EU/ml)                 |
+---------------+-----------------------+-----------------------------+
| **Safety**    | Erythema, swelling,   | 95% CI δ \< 10%             |
|               | pain and fever        |                             |
+---------------+-----------------------+-----------------------------+

\*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 ¶, 3^rd^ line: The sentence has been
    corrected as follows:

    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.  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, 3^rd^ ¶: The 1^st^
    sentence has been corrected as follows:

    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.

    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, 2^nd^ ¶: The percent of subjects in the
    separate administration study group with sore/swollen joints has
    been revised from 12% to 18%, as follows:

    1.  Strike through: Of note, reports of swollen and/or sore joints
        were frequent (\~22% for concomitant vaccination and \~~~12~~18%
        for separate administration) and appeared more frequent in this
        trial compared to the others in the BLA.

    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