02-10-2019
02-10-2019
רבמטפס
2019
:ןודנה
BOOSTRIX
/
סקירטסוב
for injection
Suspension
ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
תרבח
ג
ןיילקתימסוסקל
) מ"עב לארשי
GSK
ןוכדע לע עידוהל תשקבמ ( רישכתה לש אפורל ןולעה
BOOSTRIX
/
.סקירטסוב
דע רשע ליגמ רישכתה תיוותה תבחרה םג ללוכ ןולעה ןוכ
םינש
םינש עברא ליגל . ןונימה רטשמ ףיעס ןוכדעו
םירמוח :םיליעפ
היוותהה תרשואמה תינכדעה רישכתל
:לארשיב
For Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of
four years onwards. The administration of Boostrix should be based on official recommendations
העדוהב םינייוצמ וז ןולעל ועצובש םייונישה
.
:םינמוסמה םינוכדעל ארקמ
תפסות
םודא בתכ
הקיחמ
וק םע לוחכ בתכ הקיחמ
םינוכדיעה ןלהל
םייתוהמה
:אפורל ןולעב ושענש
Marked update
Section
Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis
of individuals from the age of tenfour years onwards (see section 4.2).
The administration of Boostrix is not intended for primary immunisationshould be
based on official recommendations.
4.1
Therapeutic
indications
Posology
A single 0.5 ml dose of the vaccine is recommended.
years onwards.
four
Boostrix may be administered from the age of
The use of Boostrix may be considered during the third trimester of pregnancy. For the
use of the vaccine before the third trimester of pregnancy, see section 4.6.
Boostrix should be administered in accordance with official recommendations and/or
with reduced
that provide low (adult) dose
local practice regarding the use of vaccines
diphtheria, tetanus and pertussis antigens.
content of
or tetanus containing
diphtheria
40 years of age that had not received any
In subjects
past 20 years, one dose of Boostrix induces an antibody response against
vaccine in the
in the majority of cases. Two
diphtheria
tetanus and
against
and protects
pertussis
maximize the
will
additional doses of a diphtheria and tetanus containing vaccine
when administered one and six months
vaccine response against diphtheria and tetanus
(see section 5.1).
after the first dose
4.2 Posology
and method of
administration
2 IU / 0.5 ML
-
DIPHTHERIA TOXOID
20 IU / 0.5 ML
-
TETANUS TOXOID
8 MCG / 0.5 ML
-
FILAMENTOUS HAEMAGGLUTININ (FHA)
8 MCG / 0.5 ML
PERTUSSIS TOXOID (PT)
-
2.5 MCG / 0.5 ML
PERTACTIN (PRN OR 69 KDA OMP)
-
Boostrix may be administered to adolescents and adults with unknown vaccination
inst diphtheria, tetanus and pertussis as part of an
status or incomplete vaccination aga
immunisation series against diphtheria, tetanus and pertussis. Based on data in adults,
two additional doses of a diphtheria and tetanus containing vaccine are recommended
rst dose to maximize the vaccine response against
one and six months after the fi
diphtheria and tetanus (see section 5.1).
……….
……….
Extremely rare cases of collapse or shock-like state (hypotonic-hyporesponsiveness
episode) and convulsions within 2 to 3 days of vaccination have been reported in DTPa
and DTPa combination vaccines.
……….
4.4
Special
warnings and
precautions
for use
……….
Boostrix can be given concomitantly with meningococcal serogroups A, C, W-135 and
Y (MenACWY) conjugate vaccines. Clinical studies in subjects aged 9 to 25 years
demonstrated that the immune responses to the tetanus, diphtheria and meningococcal
antigens were unaffected. Lower geometric mean concentrations (GMCs) were
observed for the pertussis antigens; however, these data do not suggest clinically
relevant interference.
………
4.5 Interaction
with other
medicinal
products and
other forms of
interaction
Pregnancy
The use of Boostrix may be considered during the third trimester of pregnancy.
For data relating to the prevention of pertussis disease in infants born to women
vaccinated during pregnancy, see section 5.1.
Safety data from a prospective observational study where Boostrix was administered to
pregnant women during the third trimester (793 pregnancy outcomes) as well as data
from passive surveillance where pregnant women were exposed to Boostrix or to
Boostrix-IPV (dTpa-IPV vaccine) in the 3
and 2
trimester
have shown no vaccine
related adverse effect on pregnancy or on the health of the foetus/newborn child.
Human data from prospective clinical studies on the use of Boostrix during the first
and second trimester of pregnancy are not available. However, as with other inactivated
vaccines, it is not expected that vaccination with Boostrix harms the foetus at any
trimester of pregnancy. The benefits versus the risks of administering Boostrix during
pregnancy should be carefully evaluated.
Animal studies do not indicate direct or indirect harmful effects with respect to
pregnancy, embryonal/foetal development, parturition or post-natal development (see
section 5.3).
As with other inactivatedLimited data indicate that maternal antibodies may reduce the
magnitude of the immune response to some vaccines, it is not expected that
vaccination in infants born from mothers vaccinated with Boostrix harms the foetus.
However, human data from prospective clinical studies on the
use of Boostrix during
pregnancy are not available
.
Therefore, the vaccine should be used during pregnancy
only when clearly needed, and the possible advantages outweigh the possible risks for
the foetus. . The clinical relevance of this observation is unknown.
……….
4.6
Fertility,
pregnancy
and lactation
םיפסונ םינוכדע םימייק
.ןכדועמה אפורל ןולעב ןייעל שי ףסונ עדימל .
ןולעה
אפורל
חלשנ
םוסרפל
רגאמב
תופורתה
רתאבש
דרשמ
תואירבה
https://www.old.health.gov.il/units/pharmacy/trufot/index.asp?safa=h
ןתינו לבקל ספדומ ו
לע
תרבחל הינפ ידי לזב 'חר ןיילקתימסוסקלג
:ןופלטב הוקת חתפ
03-9297100
,הכרבב
רטלב הנאיליל
הנוממ תחקור
Page 1 of 12
Boostrix Dr V6.0_notification_07.07.2019
The format of this leaflet was determined by the Ministry of Health and its content was checked
and approved in May 2019 and was updated according to the guidelines of the Ministry of Health
in July 2019.
BOOSTRIX
1.
NAME OF THE MEDICINAL PRODUCT
Boostrix suspension for injection
Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s)
content)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid
not less than 20 International Units (IU) (5 Lf)
Bordetella pertussis
antigens
Pertussis toxoid
8 micrograms
Filamentous Haemagglutinin
8 micrograms
Pertactin
2.5 micrograms
adsorbed on aluminium hydroxide, hydrated (Al(OH)
0.3 milligrams Al
and aluminium phosphate (AlPO
0.2 milligrams Al
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Boostrix is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of
individuals from the age of four years onwards (see section 4.2).
The administration of Boostrix should be based on official recommendations.
4.2
Posology and method of administration
Posology
A single 0.5 ml dose of the vaccine is recommended.
Page 2 of 12
Boostrix Dr V6.0_notification_07.07.2019
Boostrix may be administered from the age of four years onwards.
The use of Boostrix may be considered during the third trimester of pregnancy. For the use of the
vaccine before the third trimester of pregnancy, see section 4.6.
Boostrix should be administered in accordance with official recommendations and/or local
practice regarding the use of vaccines with reduced content of diphtheria, tetanus and pertussis
antigens.
Boostrix may be administered to adolescents and adults with unknown vaccination status or
incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series
against diphtheria, tetanus and pertussis. Based on data in adults, two additional doses of a
diphtheria and tetanus containing vaccine are recommended one and six months after the first
dose to maximize the vaccine response against diphtheria and tetanus (see section 5.1).
Boostrix can be used in the management of tetanus prone injuries in persons who have previously
received a primary vaccination series of tetanus toxoid vaccine and for whom a booster against
diphtheria and pertussis is indicated. Tetanus immunoglobulin should be administered
concomitantly in accordance with official recommendations.
Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals as
per official recommendations (generally 10 years).
Paediatric population
The safety and efficacy of Boostrix in children below 4 years of age have not been established.
Method of administration
Boostrix is for deep intramuscular injection preferably in the deltoid region (see section 4.4).
4.3
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.
Boostrix is contraindicated if the subject has experienced an encephalopathy of unknown
aetiology, occurring within 7 days following previous vaccination with pertussis-containing
vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination
course should be continued with diphtheria and tetanus vaccines.
Boostrix should not be administered to subjects who have experienced transient
thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive
episodes, see section 4.4) following an earlier immunisation against diphtheria and/or tetanus.
As with other vaccines, administration of Boostrix should be postponed in subjects suffering from
acute severe febrile illness. The presence of a minor infection is not a contraindication.
Page 3 of 12
Boostrix Dr V6.0_notification_07.07.2019
4.4
Special warnings and precautions for use
Vaccination should be preceded by a review of the medical history (especially with regard to
previous vaccination and possible occurrence of undesirable events).
If any of the following events are known to have occurred in temporal relation to receipt of
pertussis-containing vaccine, the decision to give doses of pertussis-containing vaccines should
be carefully considered:
Temperature of
40.0°C within 48 hours of vaccination, not due to another identifiable
cause.
Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of
vaccination.
Persistent, inconsolable crying lasting
3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits
outweigh possible risks.
As for any vaccination, the risk-benefit of immunising with Boostrix or deferring this vaccination
should be weighed carefully in a child suffering from a new onset or progression of a severe
neurological disorder.
As with all injectable vaccines, appropriate medical treatment and supervision should always be
readily available in case of a rare anaphylactic reaction following the administration of the
vaccine.
Boostrix should be administered with caution to subjects with thrombocytopenia (see section 4.3)
or a bleeding disorder since bleeding may occur following an intramuscular administration to
these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least
two minutes.
Boostrix should in no circumstances be administered intravascularly.
A history or a family history of convulsions and a family history of an adverse event following
DTP vaccination do not constitute contraindications.
Human Immunodeficiency Virus (HIV) infection is not considered as a contraindication. The
expected immunological response may not be obtained after vaccination of immunosuppressed
patients.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents
as a psychogenic response to the needle injection. This can be accompanied by several
neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb
movements during recovery. It is important that procedures are in place to avoid injury from
faints.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
4.5
Interaction with other medicinal products and other forms of interaction
Use with other vaccines or immunoglobulins
Page 4 of 12
Boostrix Dr V6.0_notification_07.07.2019
Boostrix may be administered concomitantly with human papilloma virus vaccine with no
clinically relevant interference with antibody response to any of the components of either vaccine.
Boostrix can be given concomitantly with meningococcal serogroups A, C, W-135 and Y
(MenACWY) conjugate vaccines. Clinical studies in subjects aged 9 to 25 years demonstrated
that the immune responses to the tetanus, diphtheria and meningococcal antigens were unaffected.
Lower geometric mean concentrations (GMCs) were observed for the pertussis antigens;
however, these data do not suggest clinically relevant interference.
Concomitant administration of Boostrix
with other vaccines or with immunoglobulins has not
been studied.
It is unlikely that co-administration will result in interference with the immune responses.
According to generally accepted vaccine practices and recommendations, if concomitant
administration of Boostrix with other vaccines or immunoglobulins is considered necessary, the
products should be given at separate sites.
Use with immunosuppressive treatment
As with other vaccines, patients receiving immunosuppressive therapy may not achieve an
adequate response.
4.6
Fertility, pregnancy and lactation
Pregnancy
The use of Boostrix may be considered during the third trimester of pregnancy.
For data relating to the prevention of pertussis disease in infants born to women vaccinated
during pregnancy, see section 5.1.
Safety data from a prospective observational study where Boostrix was administered to pregnant
women during the third trimester (793 pregnancy outcomes) as well as data from passive
surveillance where pregnant women were exposed to Boostrix or to Boostrix-IPV (dTpa-IPV
vaccine) in the 3
and 2
trimester
have shown no vaccine related adverse effect on pregnancy or
on the health of the foetus/newborn child.
Human data from prospective clinical studies on the use of Boostrix during the first and second
trimester of pregnancy are not available. However, as with other inactivated vaccines, it is not
expected that vaccination with Boostrix harms the foetus at any trimester of pregnancy. The
benefits versus the risks of administering Boostrix during pregnancy should be carefully
evaluated.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal/foetal development, parturition or post-natal development (see section 5.3).
Limited data indicate that maternal antibodies may reduce the magnitude of the immune response
to some vaccines in infants born from mothers vaccinated with Boostrix during pregnancy. The
clinical relevance of this observation is unknown.
Breastfeeding
Page 5 of 12
Boostrix Dr V6.0_notification_07.07.2019
The effect of administration of Boostrix during lactation has not been assessed. Nevertheless, as
Boostrix contains toxoids or inactivated antigens, no risk to the breastfed infant should be
expected. The benefits versus the risk of administering Boostrix to breastfeeding women should
carefully be evaluated by the health-care providers.
Fertility
No human data from prospective clinical studies are available. Animal studies do not indicate
direct or indirect harmful effects with respect to female fertility (see section 5.3).
4.7
Effects on ability to drive and use machines
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
4.8
Undesirable effects
Summary of the safety profile
The safety profile presented below is based on data from clinical trials where Boostrix was
administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children
(from 10 to 76 years of age) (Table 1).
The most common events occurring after Boostrix administration in both groups were local
injection site reactions (pain, redness and swelling) reported by 23.7 – 80.6% of subjects in each
trial. These usually had their onset within the first 48 hours after vaccination. All resolved
without sequelae.
Tabulated list of adverse reactions
Adverse reactions reported are listed according to the following frequency:
Very common:
1/10)
Common:
1/100 to < 1/10)
Uncommon:
1/1,000 to < 1/100)
Rare:
1/10,000 to < 1/1,000)
Very rare:
(< 1/10,000)
Within each frequency grouping, undesirable effects are presented in order of decreasing
seriousness.
Clinical trials
Table 1:
Adverse reactions reported in clinical trials with Boostrix
System Organ Class
Frequency
Adverse reactions
Subjects aged 4 - 8 years
(N=839)
Subjects aged 10 - 76
years
(N = 1931)
Page 6 of 12
Boostrix Dr V6.0_notification_07.07.2019
Infections and
infestations
Uncommon
upper respiratory tract
infection
upper respiratory tract
infection, pharyngitis
Blood and lymphatic
system disorders
Uncommon
lymphadenopathy
Metabolism and
nutrition disorders
Common
anorexia
Psychiatric disorders
Very common
irritability
Nervous system disorders
Very common
somnolence
headache
Common
headache
dizziness
Uncommon
disturbances in attention
syncope
Eye disorders
Uncommon
conjunctivitis
Respiratory, thoracic
and mediastinal
disorders
Uncommon
cough
Gastrointestinal
disorders
Common
diarrhoea, vomiting,
gastrointestinal disorders
nausea, gastrointestinal
disorders
Uncommon
diarrhoea, vomiting
Skin and subcutaneous
tissue disorders
Uncommon
rash
hyperhidrosis, pruritus,
rash
Musculoskeletal and
connective tissue
disorders
Uncommon
arthralgia, myalgia, joint
stiffness, musculoskeletal
stiffness
General disorders and
administration site
conditions
Very common
injection site reactions
(such as redness and/or
swelling), injection site
pain, fatigue
injection site reactions
(such as redness and/or
swelling), malaise, fatigue,
injection site pain
Common
pyrexia (fever ≥ 37.5°C
including fever >
39.0°C), extensive
swelling of vaccinated
limb (sometimes
involving the adjacent
joint)
pyrexia (fever
37.5°C),
injection site reactions
(such as injection site mass
and injection site abscess
sterile)
Uncommon
other injection site
reactions (such as
induration), pain
pyrexia (fever > 39.0°C),
influenza like illness, pain
Reactogenicity after repeat dose
Data on 146 subjects suggest that there might be a small increase in local reactogenicity (pain,
redness, swelling) with repeated vaccination according to a 0, 1, 6 months schedule in adults
(> 40 years of age).
Page 7 of 12
Boostrix Dr V6.0_notification_07.07.2019
Data suggest that in subjects primed with DTP in childhood a second booster dose might give an
increase of local reactogenicity.
Post-marketing surveillance
Because these events were reported spontaneously, it is not possible to reliably estimate their
frequency.
Table 2:
Adverse reactions reported with Boostrix during post-marketing surveillance
System Organ Class
Frequency
Adverse reactions
Immune system disorders
unknown
allergic reactions, including anaphylactic and
anaphylactoid reactions
Nervous system disorders
unknown
hypotonic-hyporesponsiveness episodes,
convulsions (with or without fever)
Skin and subcutaneous tissue
disorders
unknown
urticaria, angioedema
General disorders and
administration site conditions
unknown
asthenia
Following administration of tetanus toxoid containing vaccines, there have been very rare reports
of adverse reactions on the central or peripheral nervous systems, including ascending paralysis
or even respiratory paralysis (e.g. Guillain-Barré syndrome).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product Any suspected
adverse events should be reported to the Ministry of Health according to the National Regulation
by using an online form https://sideeffects.health.gov.il/
Additionally, you should also report to GSK Israel, (il.safety@gsk.com).
4.9
Overdose
Cases of overdose have been reported during post-marketing surveillance. Adverse events
following overdosage, when reported, were similar to those reported with normal vaccine
administration.
5.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Bacterial vaccines, pertussis vaccines, ATC code: J07AJ52
Page 8 of 12
Boostrix Dr V6.0_notification_07.07.2019
Immune response
Approximately one month following booster vaccination with Boostrix, the following
seroprotection / seropositivity rates were observed (Table 3).
Table 3:
Immune response in children, adolescents and adults
Antigen
Response
(1)
Adults and
adolescents from
the age of 10
years onwards
ATP
(2)
N=1694
(% vaccinees)
Children from
the age of 4
years onwards
ATP
(2)
N=415
(% vaccinees)
Diphtheria
0.1 IU/ml
97.2%
99.8%
Tetanus
0.1 IU/ml
99.0%
100.0%
Pertussis:
- Pertussis toxoid
- Filamentous haemagglutinin
- Pertactin
5 EL.U/ml
97.8%
99.9%
99.4%
99.0%
100.0%
99.8%
Response: where, at the specified time point, a concentration of antibodies against diphtheria and tetanus
0.1 IU/ml was considered as seroprotection and a concentration of antibodies against pertussis
EL.U/ml was considered as seropositivity.
ATP: According to protocol – includes all eligible subjects, who had received a single booster dose of
Boostrix, for whom immunogenicity data was available for at least one antigen at the specified time-point.
N: the minimum number of subjects with available data for each antigen
In adolescents and adults, comparative trials have demonstrated that one month post-vaccination,
diphtheria antibody titres are similar to adult-type Td vaccines with the same antigen content as
Boostrix; lower tetanus antibody titres were seen as compared to adult-type Td vaccines.
As with other adult-type Td vaccines, Boostrix induces higher titres of both anti-D and anti-T
antibodies in children and adolescents as compared to adults.
Persistence of the immune response
Three to 3.5 years, 5 to 6 years and 10 years following a first vaccination with Boostrix, the
following seroprotection/seropositivity rates were observed in subjects vaccinated according to
protocol (ATP
) (Table 4).
Table 4
: Persistence of immune response in children, adolescents and adults
Page 9 of 12
Boostrix Dr V6.0_notification_07.07.2019
Antigen
Response
(2)
Adults and adolescents from the age of 10 years onwards
(% vaccinees)
Children from the age
of 4 years onwards
(% vaccinees)
3-3.5 years
persistence
5 years persistence
10 years
persistence
3-3.5 years
persistence
5 to 6
years
persistence
Adult
(N=309)
Adole-
scent
(N=261)
Adult
(N=232)
Adole-
scent
(N=250)
Adult
(N=158)
Adole-
scent
(N=74)
(N=118)
(N=68)
Diphtheria
0.1 IU/ml
71.2%
91.6%
84.1%
86.8%
64.6%
82.4%
97.5 %
94.2 %
0.016 IU/ml
97.4%
100%
94.4%
99.2%
89.9%
98.6%
100 %
determined
Tetanus
0.1 IU/ml
94.8%
100%
96.2%
100%
95.0%
97.3%
98.4 %
98.5 %
Pertussis
Pertussis toxoid
Filamentous
haemagglutinin
Pertactin
5 EL.U/ml
90.6%
100%
94.8%
81.6%
100%
99.2%
89.5%
100%
95.0%
76.8%
100%
98.1%
85.6%
99.4%
95.0%
61.3%
100%
96.0%
58.7 %
100 %
99.2 %
51.5 %
100 %
100 %
ATP: According to protocol – includes all eligible subjects, who had received a single booster dose of Boostrix, for
whom immunogenicity data was available for at least one antigen at the specified time-point.
Response: Where, at the specified time point, a concentration of antibodies against diphtheria and tetanus
0.1 IU/ml
was considered as seroprotection and a concentration of antibodies against pertussis
5 EL.U/ml was considered as
seropositivity.
The terms ‘adult’ and ‘adolescent’ reflect the ages at which subjects received their first vaccination with Boostrix.
Percentage of subjects with antibody concentrations associated with protection against disease (
0.1 IU/ml by ELISA
assay or
0.016 IU/ml by an in-vitro Vero-cell neutralisation assay).
N = the minimum number of subjects with available data for each antigen
Efficacy in protecting against pertussis
The pertussis antigens contained in Boostrix are an integral part of the paediatric acellular
pertussis combination vaccine (Infanrix), for which efficacy after primary vaccination has been
demonstrated in a household contact efficacy study. The antibody titres to all three pertussis
components following vaccination with Boostrix are higher than those observed during the
household contact efficacy trial. Based on these comparisons, Boostrix would provide protection
against pertussis, however the degree and duration of protection afforded by the vaccine are
undetermined.
Effectiveness in the protection against pertussis disease in infants born to women vaccinated
during pregnancy
Boostrix or Boostrix-IPV vaccine effectiveness (VE) was evaluated in three observational studies,
in UK, Spain and Australia. The vaccine was used during the third trimester of pregnancy to
protect infants below 3 months of age against pertussis disease, as part of a maternal vaccination
programme.
Details of each study design and results are provided in Table 5.
Page 10 of 12
Boostrix Dr V6.0_notification_07.07.2019
Table 5:
VE against pertussis disease for infants below 3 months of age born to mothers
vaccinated during the third trimester of pregnancy with Boostrix/Boostrix-IPV:
Study location
Vaccine
Study design
Vaccination Effectiveness
UK
Boostrix-
Retrospective,
screening method
88% (95% CI: 79, 93)
Spain
Boostrix
Prospective, matched
case-control
90.9% (95% CI: 56.6, 98.1)
Australia
Boostrix
Prospective, matched
case-control
69% (95% CI: 13, 89)
CI: confidence interval
If maternal vaccination occurs within two weeks before delivery, vaccine effectiveness in the
infant may be lower than the figures in the table.
Immune response after a repeat dose of Boostrix
The immunogenicity of Boostrix, administered 10 years after a previous booster dose with
reduced-antigen content diphtheria, tetanus and acellular pertussis vaccine(s) has been evaluated.
One month post vaccination, > 99 % of subjects were seroprotected against diphtheria and tetanus
and seropositive against pertussis.
Immune response in subjects without prior or with unknown vaccination history
After administration of one dose of Boostrix to 83 adolescents aged from 11 to 18 years, without
previous pertussis vaccination and no vaccination against diphtheria and tetanus in the previous 5
years, all subjects were seroprotected against tetanus and diphtheria. The seropositivity rate after
one dose varied between 87% and 100% for the different pertussis antigens.
After administration of one dose of Boostrix to 139 adults
40 years of age that had not
received any diphtheria and tetanus containing vaccine in the past 20 years, more than 98.5% of
adults were seropositive for all three pertussis antigens and 81.5% and 93.4% were seroprotected
against diphtheria and tetanus respectively. After administration of two additional doses one and
six months after the first dose, the seropositivity rate was 100% for all three pertussis antigens
and the seroprotection rates for diphtheria and tetanus reached 99.3% and 100% respectively.
5.2
Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
5.3
Preclinical safety data
Reproductive toxicology
Fertility
Non-clinical data obtained with Boostrix reveal no specific hazard for humans based on
conventional studies of female fertility in rats and rabbits.
Pregnancy
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Non-clinical data obtained with Boostrix reveal no specific hazard for humans based on
conventional studies of embryo-foetal development in rats and rabbits, and also of parturition and
postnatal toxicity in rats (up to the end of the lactation period).
Animal toxicology and/or pharmacology
Preclinical data reveal no special hazard for humans based on conventional studies of safety and
of toxicity.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Aluminium (as aluminium salts)
Sodium chloride
Water for injections
For adjuvants, see section 2.
6.2
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other
medicinal products.
6.3
Shelf life
The expiry date of the vaccine is indicated on the label and packaging.
6.4
Special precautions for storage
Store in a refrigerator (2°C – 8°C).
After first opening, boostrix should be used immediately.
Do not freeze.
Store in the original package in order to protect from light.
6.5
Nature and contents of container
0.5 ml of suspension in pre-filled syringe (Type I glass) with a stopper (butyl rubber) with or
without needles in pack sizes of 1, 10, 20, 25 or 50.
0.5 ml suspension in vials (Type I glass) with stopper (butyl rubber) in pack sizes of 1, 10, 20, 25
or 50.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal and other handling
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Prior to use, the vaccine should be at room temperature, and well shaken in order to obtain a
homogeneous turbid white suspension.
Prior to administration, the vaccine should be
visually
inspected for any foreign particulate matter and/or variation of physical aspect. In the event of
either being observed, discard the vaccine.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
7.
Manufacturer
GlaxoSmithKline Biologicals S.A., Rixensart, Belgium.
8.
License Holder
GlaxoSmithKline (Israel) Ltd., 25 Basel St., Petach Tikva, Israel.
9.
License Number
121-34-30059
Boo DR V6.0
Trade marks are owned by or licensed to the GSK group of companies.
©2019 GSK group of companies or its licensor