BOOSTRIX

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN (PRN OR 69 KDA OMP); PERTUSSIS TOXOID (PT); TETANUS TOXOID
Available from:
GLAXO SMITH KLINE (ISRAEL) LTD
ATC code:
J07AM51
Pharmaceutical form:
SUSPENSION FOR INJECTION
Composition:
DIPHTHERIA TOXOID NLT 2 IU / 0.5 ML; TETANUS TOXOID NLT 20 IU / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 8 MCG / 0.5 ML; PERTUSSIS TOXOID (PT) 8 MCG / 0.5 ML; PERTACTIN (PRN OR 69 KDA OMP) 2.5 MCG / 0.5 ML
Administration route:
I.M
Prescription type:
Required
Manufactured by:
GLAXO SMITH KLINE BIOLOGICALS S.A
Therapeutic group:
TETANUS TOXOID, COMBINATIONS WITH DIPHTHERIA TOXOID
Therapeutic area:
TETANUS TOXOID, COMBINATIONS WITH DIPHTHERIA TOXOID
Therapeutic indications:
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
Authorization number:
121 34 30059 00
Authorization date:
2020-12-31

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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Boostrix Dr V6.0_notification_07.07.2019

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

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