Corrections to the FDA Clinical Briefing Document

December 15, 2005

Patricia Rohan, M.D.

 

 

1.  Table 5-1, page 13, success criteria for Substantial Interference with Activities of Daily Living included a p-value < 0.05.

 

2.  The footnote for Table 9-3, page 21 contains an extraneous comment which should be removed  to read as follows:

 

Table 9-3  Follow-Up by Vaccine Potency (ZOSTAVAX™ recipients)

 

Group 1

Group 2

Group 3

Group 4

Vaccine recipients (N)

835

978

8720

8737

Dose (pfu / 0.5ml dose)

50,000-62,000

34,000-42,000

26,000-33,000

21,000-26,000

Dates administered

11/98 - 11/99

04/99 – 11/99

07/99 – 12/00

07/00 – 09/01

Approx. Avg. F/U (days)

1400

1400

1200

900

See Table 4-1 for further information on Clinical Lots.

#Accelerated aged lot groups

 

2.  Table 9-7, page 25 contains an error in the header row describing PHN incidence which should be PHN Incidence (not HZ Incidence):

 

Table 9-7  Durability of ZOSTAVAX™ Effect on Major Efficacy Endpoints (MITT)

Annual Incidence of PHN1

 

 

 

 

n

 

 

 

m

Follow-Up

Time (Person-

Years)

PHN Incidence (Per 1000

Person-Years)

 

 

 

n

 

 

 

m

Follow-Up

Time (Person-

Years)

PHN Incidence

(Per 1000

Person-Years)

PHN Incidence

 

3.  The description of Protocol 009 on page 51 is revised.  The study was not placebo controlled:

 

10.2     Design

Protocol 009 is a randomized, double-blind, 18-center study comparing the safety profile of a higher potency zoster vaccine (~207,000 PFU/0.65-mL dose) with that of a lower potency (~58,000 PFU/0.65-mL dose) that had been assessed in prior clinical studies.