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Boostrix-IPV suspension for injection in pre-filled syringe

Last Updated on eMC 09-May-2017 View changes  | GlaxoSmithKline UK Contact details

1. Name of the medicinal product

Boostrix-IPV® suspension for injection in pre-filled syringe

Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)

2. Qualitative and quantitative composition

1 dose (0.5 ml) contains:

Diphtheria toxoid1

not less than 2 International Units (IU) (2.5 Lf)

Tetanus toxoid1

not less than 20 International Units (IU) (5 Lf)

Bordetella pertussis antigens

Pertussis toxoid1

8 micrograms

Filamentous Haemagglutinin1

8 micrograms

Pertactin1

2.5 micrograms

Inactivated poliovirus

type 1 (Mahoney strain)2

40 D-antigen unit

type 2 (MEF-1 strain)2

8 D-antigen unit

type 3 (Saukett strain)2

32 D-antigen unit

1adsorbed on aluminium hydroxide, hydrated (Al(OH)3)

0.3 milligrams Al3+

and aluminium phosphate (AlPO4)

0.2 milligrams Al3+

2 propagated in VERO cells

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Suspension for injection in pre-filled syringe.

Boostrix-IPV is a turbid white suspension.

4. Clinical particulars
4.1 Therapeutic indications

Boostrix-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see section 4.2).

The administration of Boostrix-IPV 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.

Boostrix-IPV may be administered from the age of three years onwards.

The use of Boostrix-IPV 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-IPV contains reduced content of diphtheria, tetanus and pertussis antigens in combination with poliomyelitis antigens. Therefore, Boostrix-IPV should be administered in accordance with official recommendations and/or local practice.

Boostrix-IPV 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, pertussis and poliomyelitis. 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-IPV 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, pertussis and poliomyelitis is indicated. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.

Repeat vaccination against diphtheria, tetanus, pertussis and poliomyelitis should be performed at intervals as per official recommendations.

Paediatric population

The safety and efficacy of Boostrix-IPV in children below 3 years of age have not been established.

Method of administration

Boostrix-IPV 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 or to neomycin or polymyxin.

Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or poliomyelitis vaccines.

Boostrix-IPV 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, tetanus and poliomyelitis vaccines.

Boostrix-IPV 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-IPV should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.

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-IPV 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-IPV 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-IPV 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

Boostrix-IPV may be administered concomitantly with any of the following monovalent or combination vaccines: measles, mumps, rubella, varicella (MMR/V) and human papilloma virus (HPV) vaccine with no clinically relevant interference with antibody response to any of the components of either vaccine (see section 4.8).

Concomitant administration of Boostrix-IPV and 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-IPV 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

Safety data from a prospective observational study where Boostrix (dTpa component of Boostrix-IPV) 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-IPV or to Boostrix in the 3rd and 2nd trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.

The use of Boostrix-IPV may be considered during the third trimester of pregnancy.

Human data from prospective clinical studies on the use of Boostrix-IPV 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-IPV harms the foetus at any trimester of pregnancy. The benefits versus the risks of administering Boostrix-IPV 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-IPV during pregnancy. The clinical relevance of this observation is unknown.

Breastfeeding

The effect of administration of Boostrix-IPV during lactation has not been assessed. Nevertheless, as Boostrix-IPV contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering Boostrix-IPV 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 in Table 1 is based on data from clinical trials where Boostrix-IPV was administered to 908 children (from 4 to 8 years of age) and 955 adults, adolescents and children (from 10 to 93 years of age).

The most common events occurring after Boostrix-IPV administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3 – 82.3% of subjects overall. 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)

Clinical trials

Table 1: Adverse reactions reported in clinical trials with Boostrix-IPV

System Organ Class

Frequency

Adverse reactions

Subjects aged 4 - 8 years (N=908)

Subjects aged 10 - 93 years (N = 955)

Infections and infestations

Uncommon

oral herpes

Blood and lymphatic system disorders

Uncommon

lymphadenopathy

lymphadenopathy

Metabolism and nutrition disorders

Common

anorexia

Uncommon

decreased appetite

Psychiatric disorders

Common

irritability

Uncommon

sleep disorder, apathy

Nervous system disorders

Very common

somnolence

headache

Common

headache

Uncommon

paraesthesia, somnolence, dizziness

Respiratory, thoracic and mediastinal disorders

Uncommon

dry throat

asthma

Gastrointestinal disorders

Common

gastrointestinal disorders (such as vomiting, abdominal pain, nausea)

Uncommon

diarrhoea, vomiting, abdominal pain, nausea

Skin and subcutaneous tissue disorders

Uncommon

pruritus

Musculoskeletal and connective tissue disorders

Uncommon

arthralgia, myalgia

General disorders and administration site conditions

Very common

injection site reactions (such as redness and/or swelling), injection site pain

injection site reactions (such as redness and/or swelling), fatigue, injection site pain

Common

pyrexia (fever ≥ 37.5°C, including fever > 39°C), extensive swelling of vaccinated limb (sometimes involving the adjacent joint), injection site reactions (such as haemorrhage, pruritus and induration)

pyrexia (fever ≥ 37.5°C), injection site reactions (such as haematoma, pruritus, induration and warmth numbness)

Uncommon

fatigue

extensive swelling of vaccinated limb (sometimes involving the adjacent joint), pyrexia (fever > 39.0°C), chills, pain

Coadministration with MMR/V vaccines in children aged 3-6 years

Boostrix-IPV was coadministered with MMR/V vaccines in 2 clinical studies with 406 children aged 3-6 years. In these studies, upper respiratory tract infection and rash were commonly reported. Fever, irritability, fatigue, loss of appetite and gastrointestinal disorders (including diarrhoea and vomiting) were reported with a higher frequency (very common) when compared to Table 1 while all other adverse reactions occurred at the same or lower frequency.

Adverse reactions additionally reported during clinical studies with Boostrix (dTpa component of Boostrix-IPV, administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age), are listed in Table 2.

Table 2: 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)

Infections and infestations

Uncommon

upper respiratory tract infection, pharyngitis

Nervous system disorders

Uncommon

disturbances in attention

syncope

Eye disorders

Uncommon

conjunctivitis

Respiratory, thoracic and mediastinal disorders

Uncommon

cough

Gastrointestinal disorders

Uncommon

diarrhoea

Skin and subcutaneous tissue disorders

Uncommon

hyperhidrosis, rash

Musculoskeletal and connective tissue disorders

Uncommon

joint stiffness, musculoskeletal stiffness

General disorders and administration site conditions

Very common

malaise

Common

injection site reactions (such as injection site mass and injection site abscess sterile)

Uncommon

pain

influenza like illness

Reactogenicity after repeat dose

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 3: Adverse reactions reported with Boostrix-IPV 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

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 and viral vaccines combined, ATC code: J07CA02

Immune response

The immune responses to Boostrix-IPV were evaluated in clinical trials carried out in subjects of different ages having different vaccination histories (see section 4.8).

The following immune responses were observed across studies one month post vaccination with Boostrix-IPV in children, adolescents and adults (Table 4).

Table 4: Immune response in children, adolescents and adults

Antigen

Response

Children aged 3 to 8 years

N=1195

Adults, adolescents and children aged from 10 years onwards

N=923

(% vaccinees)

(% vaccinees)

Diphtheria

≥ 0.1 IU/ml

100%

82.2 – 100%

≥ 0.016 IU/ml (1)

NA

87.7 – 100% (2)

Tetanus

≥ 0.1 IU/ml

99.9 – 100%

99.6 – 100%

Pertussis

Booster response (3)

Pertussis toxoid

84.6 – 90.6%

79.8 – 94.0%

Filamentous haemagglutinin

90.1 – 98.8%

90.7 – 97.2%

Pertactin

94.2 – 96.6%

90.0 – 96.7%

Inactivated poliovirus

≥8 ED50

type 1

98.8 – 100%

99.6 – 100%

type 2

99.2 – 100%

99.6 – 100%

type 3

99.4 – 100%

99.1 – 100%

N=number of subjects

(1) 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).

(2) This assay was not performed in study HPV-042.

(3) Booster response defined as:

- for initially seronegative subjects, antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 El.U/ml);

- for initially seropositive subjects with Pre booster vaccination concentration ≥ 5 El.U/ml and < 20 El.U/ml: an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.

- for initially seropositive subjects with Pre booster vaccination concentration ≥ 20 El.U/ml: an increase in antibody concentrations of at least two times the Pre booster vaccination concentration

As with other adult-type Td vaccines, Boostrix-IPV induces higher seroprotection rates and higher titres of both anti-D and anti-T antibodies in children and adolescents as compared to adults.

Persistence of the immune response

Five years following a first vaccination of children 4 to 8 years of age with Boostrix-IPV, the following seroprotection / seropositivity rates were observed in subjects vaccinated according to protocol (ATP1):

Antigen

Response(2)

Children 4 to 8 years of age

(% vaccinees)

(N=337)

Diphtheria

≥ 0.1 IU/ml

89.4%

≥ 0.016 IU/ml(3)

98.2%

Tetanus

≥ 0.1 IU/ml

98.5%

Pertussis

Pertussis toxoid

Filamentous haemagglutinin

Pertactin

≥ 5 EL.U/ml

40.9%

99.7%

97.1%

Poliovirus type 1

Poliovirus type 2

Poliovirus type 3

≥ 8 ED50

98.8%

99.7%

97.1%

(1)ATP: According to protocol – includes all eligible subjects, who had received a single booster dose of Boostrix-IPV, for whom immunogenicity data was available for at least one antigen at the specified time-point.

(2)Response: Where, after five years, a concentration of antibodies against diphtheria and tetanus ≥ 0.1 IU/ml was considered as seroprotection, a concentration of antibodies against pertussis ≥ 5 EL.U/ml was considered as seropositivity and dilution titres against poliovirus types 1, 2 and 3 of 1:8 were considered as positive.

(3)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

Three to 3.5 years, 5 and 10 years following a first vaccination with Boostrix (dTpa component of Boostrix-IPV), the following seroprotection / seropositivity rates were observed in subjects vaccinated according to protocol (ATP1):

Antigen

Response(2)

Adults and adolescents from the age of 10 years onwards

(% vaccinees)

3-3.5 years persistence

5 years persistence

10 years persistence

Adult(3)

(N=309)

Adolescent(3)

(N=261)

Adult(3)

(N=232)

Adolescent(3)

(N=250)

Adult(3)

(N=158)

Adole-scent(3)

(N=74)

Diphtheria

≥ 0.1 IU/ml

71.2%

91.6%

84.1%

86.8%

64.6%

82.4%

≥ 0.016 IU/ml(4)

97.4%

100%

94.4%

99.2%

89.9%

98.6%

Tetanus

≥ 0.1 IU/ml

94.8%

100%

96.2%

100%

95.0%

97.3%

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%

(1)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.

(2)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.

(3)The terms 'adult' and 'adolescent' reflect the ages at which subjects received their first vaccination with Boostrix.

(4)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

Immune response after a repeat dose of Boostrix-IPV or Boostrix

The immunogenicity of Boostrix-IPV, administered 5 years after a first booster dose of Boostrix-IPV at 4 to 8 years of age, has been evaluated. One month post vaccination, > 99 % of subjects were seropositive against pertussis and seroprotected against diphtheria, tetanus and all three poliovirus types.

The immunogenicity of Boostrix (dTpa component of Boostrix-IPV), administered 10 years after a first 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 (dTpa component of Boostrix-IPV) 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-IPV to 140 adults ≥ 40 years of age (including those who have never been vaccinated or whose vaccination status was unknown), that had not received any diphtheria and tetanus containing vaccine in the past 20 years, more than 96.4% of adults were seropositive for all three pertussis antigens and 77.7% and 95.7% were seroprotected against diphtheria and tetanus respectively.

Efficacy in protecting against pertussis

The pertussis antigens contained in Boostrix-IPV 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-IPV are at least as high or higher than those observed during the household contact efficacy trial. Based on these comparisons, Boostrix-IPV would provide protection against pertussis, however the degree and duration of protection afforded by the vaccine are undetermined.

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-IPV reveal no specific hazard for humans based on conventional studies of female fertility in rats and rabbits.

Pregnancy

Non-clinical data obtained with Boostrix-IPV 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

Medium 199 (as stabilizer containing amino acids, mineral salts, vitamins and other substances)

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

3 years

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Upon removal from refrigerator, the vaccine is stable for 8 hours at 21°C.

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 stopper (butyl rubber) with or without needles in pack sizes of 1 or 10.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

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. Marketing authorisation holder

SmithKline Beecham Ltd

980 Great West Road

Brentford

Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK

Stockley Park West, Uxbridge

Middlesex, UB11 1BT

8. Marketing authorisation number(s)

PL 10592/0214

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 6 July 2005

Date of last renewal: 16 December 2008

10. Date of revision of the text

21/04/2017

Company contact details

GlaxoSmithKline UK

Company image
Address

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Fax

+44 (0)208 990 4328

Medical Information e-mail
Telephone

0800 221 441

E-mail
Customer Care direct line

0800 221 441

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Active ingredients

diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated)

Legal categories

POM - Prescription Only Medicine

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