Dokument firmy GSK dotyczący zgonów ujawniony przez Włoski sąd.pdf

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CONFIDENTIAL
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Table of Contents
1. INTRODUCTION
2. WORLDWIDE MARKET AUTHORISATION STATUS
3. UPDATE ON REGULATORY AUTHORITY OR
MANUFACTURER ACTIONS TAKEN FOR SAFETY REASONS
4. CHANGES TO REFERENCE SAFETY INFORMATION
5. PATIENT EXPOSURE
5.1. Market Experience
6. INDIVIDUAL CASE HISTORIES
7. STUDIES
7.1. Newly-Analysed Studies
7.2. Targeted Safety Studies
7.3. Other Safety Studies
7.4. Published Safety Studies
8. OTHER INFORMATION
8.1. Late-breaking information
8.2. Cumulative review of Gaze palsy
9. OVERALL SAFETY EVALUATION AND CONCLUSION
10. REFERENCES
APPENDICES
APPENDIX 1 : SUMMARY TABULATION OF INFANRIX HEXA
ADVERSE EVENTS
APPENDIX 2 : SUMMARY of CASES OF GAZE PALSY SINCE
LAUNCH
APPENDIX 3 : PSUR - 23 OCTOBER 2010 to 22 OCTOBER 2011
APPENDIX 4 : PSUR - 23 OCTOBER 2009 to 22 OCTOBER 2010
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1.
INTRODUCTION
This summary bridging report integrates the information presented in the two Combined
Diphtheria, Tetanus and Acellular Pertussis, Hepatitis B enhanced Inactivated
Poliomyelitis and Haemophilus influenzae type B vaccine (Infanrix™ hexa) periodic
safety update reports (PSURs) covering the two year period from 23 October 2009 to 22
October 2011. Further details are provided below.
Report Number
16
15
Dates of Report
23 October 2010 - 22 October 2011
23 October 2009 - 22 October 2010
Time Period
1 year
1 year
This report presents data on all formulations.
2.
WORLDWIDE MARKET AUTHORISATION STATUS
Infanrix™ hexa has been approved in 92 countries (see APPENDIX 1 of PSUR 16).
3.
UPDATE ON REGULATORY AUTHORITY OR
MANUFACTURER ACTIONS TAKEN FOR SAFETY
REASONS
During the period under review, no actions have been taken for safety reasons concerning
withdrawal, rejection, suspension or failure to obtain a renewal of a Marketing
Authorisation; neither have there been any dosage modifications, changes in target
population, formulation changes, restriction on distribution, or clinical trial suspension.
4.
CHANGES TO REFERENCE SAFETY INFORMATION
The Reference Safety Information (RSI) in effect at the beginning of the reporting period
is the Global Prescriber Information (GPI) of Global Datasheet (GDS) version 9 dated 23
November 2007. Refer to APPENDIX 2A of PSUR 15; the RSI is identified by double-
underlining within the GPI.
During the period of this report one new version (version 10) of the RSI was issued.
Refer to APPENDIX 2B of PSUR 15; the RSI is identified as grey shaded text within the
GPI. In CSI version 10 dated 21 October 2010 the following changes were implemented:
A warning about the risk of syncope (fainting) after any vaccination was added in the
Warnings and Precautions Section: Syncope (fainting) can occur following, or even
before, any vaccination as a psychogenic response to the needle injection. It is
important that procedures are in place to avoid injury from faints.
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The following changes were implemented as well in RSI version 10 compared to
version 9, although not mentioned in PSUR 15:
The Company revised the text considered as RSI in the GDS taking into account the
fact that any text that refers to ‘ negative data’ or ‘ no data available’ should not be
considered as RSI. As a consequence, the following is no longer considered to be
RSI:
Dosage and Administration Section
Interactions Section (except for the key message related to higher incidence of
fever reported with Infanrix™ hexa)
Pregnancy and Lactation Section
The sentence The safety profile presented below is based on data from more
than 16 000 subjects in the Clinical Trials Section.
Overdosage Section
Several changes were made to the Use and Handling Section:
wording regarding reconstitution of the vaccine was clarified
paragraph related to Bioset presentation was deleted
instructions related to PRTC pre-filled syringe and information related to the
vial and vial presentation were added
a statement regarding disposal of unused products or waste material was added
5.
5.1.
PATIENT EXPOSURE
Market Experience
Information on the actual number of people exposed to Infanrix™ hexain the different
countries is not available to the MAH. Therefore, the total patient exposure is
approximated by the number of doses distributed which is the most reliable data available
with regard to patient exposure for a vaccine in a post-marketing setting.
It is important to note that the sales database from which data are retrieved is an in-house
‘ living’ database and is subject to updates and corrections depending on information
provided by GSK local country subsidiaries (e.g. vaccine doses may be returned by
subsidiaries to the central warehouse). These constant updates may result in discrepancies
between consecutive queries of the database.
During the period covered by this report 24 283 415 doses of Infanrix™ hexahave been
distributed. Since launch until the data lock point (DLP) of this report, 72 931 338 doses
have been distributed. As vaccination with Infanrix™ hexa can vary between 1 and 4
doses per subject in accordance with local recommendations and compliance with the
vaccination schedule, and assuming that one dose distributed corresponds to one dose
administered, post-marketing exposure to Infanrix™ hexa during the SBR reporting
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period is estimated to be between 6 070 854 and 24 283 415 subjects. The number of
subjects exposed since launch until the data lock point of this report is estimated between
18 232 834 and 72 931 338.
6.
INDIVIDUAL CASE HISTORIES
A total of 2408 reports meeting ICH E2C PSUR criteria have been received during the
period of this report. These reports include all serious and non-serious reports from
spontaneous notifications (including published reports), but exclude all non-healthcare
professional reports and all non-serious reports received solely from regulatory
authorities. In addition, unblinded, serious attributable reports arising from clinical
studies, post-marketing surveillance studies, named patient use or solicited reports
following use of a GSK product have been included. These cases are presented within the
summary tabulation in Appendix 1.
The tabulation shows the MedDRA System Organ Class (SOC), High Level Group Term
(HLGT) and Preferred Term (PT), and the number of unique cases for each adverse
event.
The total number of cases presented in line listings and summary tabulations in the series
of PSURs appended to this summary report is 2388.
It should be noted that the data-set for the summary tabulation differs from the data-sets
included in the individual PSURs during the time period given that the summary
tabulation in this report contains follow-up information on cases previously included in
the PSURs.
7.
7.1.
STUDIES
Newly-Analysed Studies
Three new corporate studies relevant to the safety of Infanrix™ hexa were completed and
analysed during the period of this report.
Study #112157 (DTPa-HBV-I PV=Hib-M enC-TT-002 PRI) A phase II, open-
label, randomised, multicentre study to evaluate the safety and immunogenicity of
GSK Biologicals‟ DTPa-HBV-IPV/Hib-MenC-TT vaccine co- dministered with
GSK Biologicals‟ 10-valent pneumococcal conjugate vaccine in healthy infants
when administered as a three-dose primary vaccination course at 2, 3 and 4 months
of age.
The observed incidence of solicited and unsolicited adverse events was in the same
range in the 3 groups, i.e. “ Hepta” (candidate heptavalent vaccine), “ HexaMnC”
(Infanrix™ hexa co-administered with conjugate meningococcal vaccine
(Menjugate), and “ HexaPn” [Infanrix™ hexa co-administered with conjugate
pneumococcal vaccine (Synflorix)]; all the vaccines administered in the study were
well tolerated. One SAE (thrombocytopenia) reported for a subject in the Hepta
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