I LEAD THE CLINICAL DEVELOPMENT
AT GLAXO SMITHKLINE VACCINE.
IT IS MY PRIVILEGE TO PRESENT
THE DEVELOPMENT OF THE INFLUENZA
VACCINE.
YOU ALREADY HEARD THAT THE
DISEASE CAN BE SERIOUS AND ONLY
PARTIALLY ADDRESS AND WE ARE
DEVELOPING THE VACCINE
CONTAINING TWO B STRAINS.
ON AN AVERAGE APPROXIMATELY 25%
OF THE TIME INFLUENZA B
CIRCULATES AND MORTALITY IS
SECOND TO IT AND ESPECIALLY IN
THOSE OLDER THAN 65 YEARS OF
AGE.
IN 2010 AND 2011, 38% OF ALL
INFLUENZA ASSOCIATED WITH
PEDIATRIC DEATHS WERE INFLUENZA
B.
IT DOES CIRCULATE AND TWO
LINEAGES ARE CIRCULATING.
IN SIX OUT OF THE PAST 11
SEASONS, VACCINE CONTAINED THE B
VACCINE AND THAT'S B CONTAINED
IN THE VACCINE WAS NOT THE
PREDOMINANT STRAIN.
IT SEEMS TO BE THE LOGICAL STEP.
THEY DEVELOPED THE CANDIDATE AND
THEY HAVE TWO LICENSED.
WE HAVE COMMITTED LICENSE
APPLICATIONS FOR BOTH VACCINES
FOR THE FORMULATIONS.
FIRST IT WAS SUBMITTED EARLY
THIS YEAR WHICH THE ONLY
DIFFERENCE IS THE STRAIN IS
ADDED.
THIS IS MANUFACTURED IN DREZ
DON, GERMANY.
WE HAVE ANOTHER CANDIDATE WHICH
IS MANUFACTURED IN QUEBEC.
THE TARGET INDICATION WOULD BE
ACTIVE IMMUNIZATION CAUSED BY
THE TWO VIRUS SUBTYPES AND THE
TWO TYPES CONTAINED IN THE
VACCINE IN ADULTS AND CHILDREN
AS FROM THREE YEARS OF AGE.
>> THE TWO STUDIES THAT I AM
GOING TO PRESENT TO YOU HERE HAD
SIMILAR OBJECTIVES.
THE STUDY WAS CONDUCTED IN THREE
TO 17 YEARS OF AGE AND DOES
STUDY IN 18 YEARS AND ABOVE.
WE CONFIRMED IMMUNOGENIC
SUPERIORITY FOR THE ADDED B
STRAIN VERSUS TWO FORMULATIONS
THAT CONTAIN DIFFERENT B
STRAINS.
WE ALSO CONFIRMED THE
NON-INFERIORITY TO THE THREE
COMMON CORRESPONDING STREAMS TO
EACH.
IN ADDITION WE DESCRIBED THEM TO
BE THE SAFETY AND THE
PARAMETERS.
IN THE DOSE STUDY, WE ALSO
DEMONSTRATED CONSISTENCY OF
PREPRODUCTION LOTS.
IN THE INTEREST OF TIME, I WILL
DESCRIBE THE RESULTS ON THE END
POINTS WHICH ARE IN THE RED
BOXES.
THAT IS SUPERIORITY AS WELL AS
FOR BOTH STUDIES.
LET'S LOOK AT THE STUDY
DESIGNED.
THEY WERE SIMILAR AS WELL FOR
THE PEDIATRIC AND THE ADULT
STUDIES.
THEY WERE RANDOMIZED AT TRIALS
AND THEY WERE IN 3 TO 17 YEARS
OF AGE.
IT WAS AGE STRATIFIED FURTHER IN
3 TO 8 AND 9 TO 17.
WE HAD MORE THAN 4,000 CHILDREN
IN THE ADULT STUDIES.
THAT WAS ALSO STRATIFIED IN 18
TO 64 AND ABOUT 64 YEARS OF AGE.
IN BOTH WE COMPARED TO TWO
FORMULATIONS.
AGAIN THEY CONTAINED AN EXTRA B
STRAIN FROM ALTERNATE LINEAGE.
BOTH WERE IN AND THE SAME TWO A
STRAINS WERE IN BOTH, BUT EACH
OF THEM CONTAINED EITHER A B
VICTORIOUS AND THE BYAMAGATA
STRAIN.
WE CONDUCTED THE TEST IN FIVE
COUNTRIES AND U.S. CONTRIBUTED
THE MAXIMUM NUMBER OF SUBJECTS
IN BOTH.
IN PEDIATRIC STUDIES OF PRIME
SUBJECTS TO RECEIVE ONE DOSE AND
PRIME SUBJECTS RECEIVED TWO
DOSES.
THIS DEFINITION WAS USED AND BY
PREVIOUS VACCINES PRIMING.
THEY HAD RECEIVED TWO OR MORE
MODELS WITH THE VACCINE IN THE
PAST.
THEY WERE CONSIDERED PRIME.
IN THE ADULT STUDIES, EACH
RECEIVED ONLY ONE DOSE.
THE BLOOD SAMPLES WERE COLLECTED
AND WE HAD THE SAFETY ASSESSMENT
DONE INITIALLY FOR DAY FOR LOCAL
AND GENERAL SYMPTOMS AND 28 DAYS
AND UP TO SIX MONTHS OF EXTENDED
SAFETY.
LET'S LOOK AT THE RESULTS IN
PEDIATRIC STUDY.
ON THIS SLIDE YOU SEE PRE AND
POST GEOMETRIC FOR ALL FOUR
STRAINS CONTAINED.
THEY ARE SHOWN AS THE FIRST BAR
GRAPH IN ORANGE.
THE COLORS ARE A LITTLE BIT
CHANGED HERE.
THEN CONTAINING IN BLUE AND THE
LAST BAR IS CONTAINING THE B
YAMAGATA.
FOR ALL FOUR STRAINS, 1 H AND
YOU CAN SEE SIMILAR RESPONSES
AROUND 200 RESPECTIVELY.
YOU GO TO B VICTORIA AND B
YAMAGATA, YOU CAN SEE CONTAINING
THE CORRESPONDING B STRAIN SHOWS
SIMILAR RESPONSES.
THIS IS THE NON-INFERIORITY
ANALYSIS.
YOU SEE THE RED ARROWS WHICH
SHOWS THE RESPONSE COMPARED TO
CONTAINING ALTERNATE LINEAGE
THAT. IS CONTAINED THERE, BUT
NOT IN THE TIB AND YOU SEE THE
RESPONSE IN THE SCENE, BUT NOT
IN THE TRAVEL VACCINE.
I WILL SHOW YOU THE NUMBERS FOR
THE SUPERIORITY IN TERMS OF
CONVERSION RATE AS WELL, BUT
LET'S LOOK AT THE ADULT DATA
NOW.
FOR ADULTS IF YOU FOCUS THAT
NON-INFERIORITY WITH ALL FOUR
STRAINS THROUGH THE
CORRESPONDING, THEY ARE ALSO
SCENE AT THE PREDEFINED AREA FOR
SUPERIORITY WERE ALSO MET.
AS WE GO TO THE NEXT SLIDE, YOU
SEE INCREASED IMMUNE RESPONSES
FOR THE ADDED B STRAIN.
FIRST IN TERMS OF THE RATIO AND
CONVERSION RATE DIFFERENCES.
FOR THE RATIO, IF YOU FOCUS, THE
FIRST ROW IS FOR INCREASED
RESPONSE FOR B YAMAGATA.
THE VICTORIA DID NOT CONTAIN THE
YAMAGATA.
THE INCREASE WAS SEEN IN
PEDIATRIC STUDY AND 1.5 FOLD
INCREASE FOR B YAMAGATA STRAIN.
VICTORIA STRAIN WAS CONTAINED
HERE, BUT NOT IN THE YAMAGATA.
THE 2.9 FOLD INCREASE IN THE
RATIO VERSUS 1.6% INCREASE FOR
THE ADULTS.
THE CONVERSION RATE DIFFERENCES,
30 TO 40% INCREASE IN TERMS OF
CONVERSION RATE WAS OBSERVED IN
PEDIATRIC STUDY WHERE AS 10 TO
16% INCREASE WAS SEEN IN THE
CONVERSION RATE DIFFERENCES FOR
THE ADULT TRIAL.
LOOKING AT THE REACTION WITH
SAFETY, WE HAVE SIMILAR
RESPONSES WITH BOTH VACCINES.
HERE YOU SEE ALL SYMPTOMS VERSUS
GENERAL AND LOCAL SYMPTOMS IN
THE BAR GRAPH.
THE SYMPTOMS WERE ALSO SIMILAR.
I AM NOT SHOWING THE DATA
SEPARATELY, BUT NO DIFFERENCES
IN TEMPERATURE OR ANY OTHER
SYMPTOMS.
YOU SEE ANY SYMPTOMS AND LOCAL
SYMPTOMS DURING SEVEN DAYS FOR
VACCINATION OR SIMILAR.
AS WE LOOK AT THE 27 DAY DATA
AND 180 DAY DATA, THE
UNSOLICITED SYMPTOMS WERE IN THE
SIMILAR RANGE AND ALSO THEY WERE
IN THE SIMILAR RANGE.
IF YOU LOOK AT MEDICALLY
ATTENDED EVENTS, THEY WERE IN
THE SAME RANGE.
THE SERIOUS ADVERSE EVENTS WERE
ORDERED IN THE SIMILAR PERCENT
OF SUBJECTS.
THERE WERE NO ADVERSE EVENTS
WHICH WERE CONSIDERED RELATED OR
REPORTED IN THE PEDIATRIC STUDY
OR IN THE ADULT STUDY.
YOU SEE THE ADULT STUDY AGAIN
WITH SIMILAR RESPONSES FOR QIV
IN THE FIRST BAR GRAPH YOU SEE.
THE SECOND IS THE CONTAINING V
VICTORIA AND THE OTHER
CONTAINING THE YAMAGATA.
THE GENERAL OR LOCAL SYMPTOMS,
NO DIFFERENCES OBSERVED BETWEEN
THEM.
FOR THE FOLLOW-UP, BE DID NOT
OBSERVE DIFFERENCES.
NOT ADVERSE EVENTS WERE REPORT
TO BE RELATED BY THE
INVESTIGATORS.
SO TO SUMMARIZE, WE MET ALL
OBJECTIVES IN THE PEDIATRIC AND
ADULT STUDIES.
ALL SPECIFIED IMMUNOJENS WERE
MET AND THE RESPONSES TO THE
STRAIN WAS DEMONSTRATED.
NO COMPROMISED IMMUNE RESPONSE
FOR THE THREE SHARED STRAINS.
BY ADDING AN EXTRA B STRAIN, WE
DID NOT DECREASE THE RESPONSES.
OR IN OTHER WORDS WE
DEMONSTRATED NON-INFERIORITY.
IN THE BACK UP SLIDES, WE DO
SHOW THE ANALYSIS, BUT IN THE
INTEREST OF TIME, I HAVE NOT
SHOWN YOU THE DATA.
WE DID SEE AN ACCEPTABLE
REACTION ON THE SAFETY PROFILE
SIMILAR.
IT IS EXPECTED TO INCLUDE
PROTECTION AGAINST INFLUENZA B.
WE EXPECT LICENSURE FOR THEM IN
DECEMBER OF THIS YEAR.
THAT IS WITHIN TWO MONTHS.
THE LICENSE OF THE OTHER VACCINE
HAS SUBMITTED THE APPLICATION
BEFORE WE EXPECT THE LICENSE
NEXT YEAR.
IN TERMS OF SUPPLIES, WE CAN
SUPPLY 15 MILLION DOSES FOR THE
U.S. FOR THE NEXT SEASON.
THAT IS 2013-14 INFLUENZA SEASON
AND UP TO 75 MILLION DOSES FOR
THE 2014-15.
THE SEASON THERE AFTER.
THEY WILL STILL BE AVAILABLE.
I WANT TO THANK ALL THE
VOLUNTEERS WHO VOLUNTEERED IN
THE STUDY.
THEIR PARENTS IN THE PEDIATRIC
STUDY WHO BROUGHT THE CHILDREN
TO PARTICIPATE IN THE TRIAL AND
ALSO THE ADULT PARTICIPANTS.
I WANT TO THANK THE TEAM AND
ALSO ALL THE INVESTIGATORS AND
THEIR TEAMS.
THANK YOU.