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REPEVAX SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE

Active substance(s): DIPHTHERIA TOXOID ADSORBED PURIFIED / PERTACTIN ADSORBED PURIFIED / PERTUSSIS ADSORBED PURIFIED FILAMENTOUS HAEMAGGLUTININ / PERTUSSIS FIMBRIAL AGGLUTINOGENS 2 AND 3 ADSORDED PURIFIED / PERTUSSIS TOXOID PURIFIED ADSORBED / POLIOMYELITIS INACTIVATED VIRUS TYPE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
REPEVAX, 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 Toxoid............................................Not less than 2 IU* (2 Lf)
Tetanus Toxoid ............................................Not less than 20 IU* (5 Lf)
Pertussis Antigens
Pertussis Toxoid.................................................................... 2.5 micrograms
Filamentous Haemagglutinin ................................................ 5 micrograms
Pertactin ................................................................................ 3 micrograms
Fimbriae Types 2 and 3......................................................... 5 micrograms
Poliovirus (Inactivated)**
Type 1 ................................................................................. 40 D antigen units
Type 2 ................................................................................... 8 D antigen units
Type 3 ................................................................................. 32 D antigen units
Adsorbed on aluminium phosphate .......................1.5 mg (0.33 mg aluminium)
* As lower confidence limit (p = 0.95) of activity measured according to the
assay described in the European Pharmacopoeia.
** Produced in Vero cells.
REPEVAX may contain traces of formaldehyde, glutaraldehyde,
streptomycin, neomycin, polymyxin B and bovine serum albumin, which are
used during the manufacturing process (see sections 4.3 and 4.4).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe
REPEVAX appears as a uniform, cloudy, white suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
REPEVAX is indicated for active immunization against diphtheria, tetanus, pertussis
and poliomyelitis in persons from 3 years of age as a booster following primary
immunization.
The use of REPEVAX should be determined on the basis of official
recommendations.

4.2

Posology and method of administration
Posology
A single injection of one (0.5 mL) dose is recommended in all indicated age groups.
REPEVAX is a vaccine containing low-dose diphtheria toxoid plus tetanus toxoid in
combination with pertussis and polio antigens for booster vaccinations.
In adolescents and adults with an unknown or incomplete diphtheria or tetanus
vaccination status against diphtheria or tetanus, one dose of REPEVAX® can be
administered as part of a vaccination series to protect against pertussis and
poliomyelitis and in most cases also against tetanus and diphtheria. One additional
dose of a diphtheria- and tetanus- (dT) containing vaccine can be administered one
month later followed by a 3rd dose of a diphtheria or dT containing vaccine 6 months
after the first dose to optimize protection against disease (see section 5.1). The
number and schedule of doses should be determined according to local
recommendations.
REPEVAX can be used for repeat vaccination to boost immunity to diphtheria,
tetanus and pertussis at 5 to 10 year intervals (see section 5.1). Repeat vaccination
should be performed according to official recommendations.
REPEVAX can be used in the management of tetanus prone injuries with or without
concomitant administration of Tetanus Immunoglobulin according to official
recommendations.
Paediatric Population
REPEVAX should not be used in children under 3 years of age.
Children from the age of 3 years onwards and adolescents should receive the same
dosage as adults.

Method of administration
A single injection of one dose (0.5 mL) of REPEVAX should be administered
intramuscularly. The preferred site is into the deltoid muscle.
REPEVAX should not be administered into the gluteal area; intradermal or
subcutaneous routes should not be used (in exceptional cases the subcutaneous route
may be considered, see section 4.4).
Precautions to be taken before handling or administering the medicinal product
For instructions on handling of the medicinal product before administration, see
section 6.6.

4.3

Contraindications


4.4

REPEVAX should not be administered to persons with known hypersensitivity
-

to diphtheria, tetanus, pertussis or poliomyelitis vaccines

-

to any other component of the vaccine (see Section 6.1)

-

to any residual substances carried over from manufacture (formaldehyde,
glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum
albumin), which may be present in undetectable trace amounts.



REPEVAX should not be administered to persons who experienced an
encephalopathy of unknown origin within 7 days of previous immunization with a
pertussis-containing vaccine.



As with other vaccines, administration of REPEVAX should be postponed in persons
suffering from an acute severe febrile illness. The presence of a minor infection (e.g.,
mild upper respiratory infection) is not a contraindication.

Special warnings and precautions for use
REPEVAX should not be used for primary immunization.
Regarding the interval between a booster dose of REPEVAX and preceding booster
doses of diphtheria and/or tetanus containing vaccines, the official recommendations
should generally be followed. Clinical data in adults have demonstrated that there was
no clinically relevant difference in rates of adverse reactions associated with
administration of REPEVAX as early as 4 weeks, compared to at least 5 years after a
preceding dose of tetanus and diphtheria-containing vaccine.
Prior to immunization

Vaccination should be preceded by a review of the person’s medical history (in
particular previous vaccinations and possible adverse events). In persons who have a
history of serious or severe reaction within 48 hours of a previous injection with a
vaccine containing similar components, administration of REPEVAX vaccine must
be carefully considered.
As with all injectable vaccines, appropriate medical treatment and supervision should
be readily available for immediate use in case of a rare anaphylactic reaction
following the administration of the vaccine.
If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior
vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus
toxoid should be based on careful consideration of the potential benefits and possible
risks.
REPEVAX should not be administered to individuals with a progressive or unstable
neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a
treatment regimen has been established and the condition has stabilized.
The rates and severity of adverse events in recipients of tetanus toxoid antigen are
influenced by the number of prior doses and level of pre-existing antitoxins.
The immunogenicity of the vaccine could be reduced by immunosuppressive
treatment or immunodeficiency. It is recommended to postpone the vaccination until
the end of such disease or treatment if practical. Nevertheless, vaccination of HIV
infected persons or persons with chronic immunodeficiency, such as AIDS, is
recommended even if the antibody response might be limited.
Administration precautions
Do not administer by intravascular or intradermal injection.
Intramuscular injections should be given with care in patients on anticoagulant
therapy or suffering from coagulation disorders because of the risk of haemorrhage.
In these situations and following official recommendations the administration of
REPEVAX by deep subcutaneous injection may be considered, although there is a
risk of increased local reactions.
Syncope (fainting) can occur in association with administration of injectable
vaccines, including REPEVAX. Procedures should be in place to prevent falling
injury and manage syncopal reactions.
Other considerations

As with any vaccine, a protective immune response may not be elicited in all
vaccinees (see section 5.1).
A persistent nodule at the site of injection may occur with all adsorbed vaccines,
particularly if administered into the superficial layers of the subcutaneous tissue.

4.5

Interaction with other medicinal products and other forms of interaction
REPEVAX may be administered concomitantly with a dose of inactivated
influenza vaccine, based on the results of a clinical trial conducted in persons
60 years of age and older.

REPEVAX may be administered concomitantly with a dose of hepatitis B
vaccine.
REPEVAX may be administered concurrently with a dose of recombinant
Human Papillomavirus vaccine with no significant interference with antibody
response to any of the components of either vaccine. However, a trend of
lower anti-HPV GMTs was observed in the concomitant group. The clinical
significance of this observation is not known. This is based on the results from
a clinical trial in which REPEVAX was administered concomitantly with the
first dose of Gardasil (see section 4.8).
Separate limbs must be used for the site of injection. Interaction studies have
not been carried out with other vaccines, biological products or therapeutic
medications. However, in accordance with commonly accepted immunization
guidelines, since REPEVAX is an inactivated product it may be administered
concomitantly with other vaccines or immunoglobulins at separate injection
sites.
In the case of immunosuppressive therapy please refer to Section 4.4.

4.6

Pregnancy and lactation
Pregnancy
The effect of REPEVAX on embryo-foetal development has not been
assessed. No teratogenic effect of vaccines containing diphtheria or tetanus
toxoids, or inactivated poliovirus has been observed following use in pregnant
women.
Available data on exposures during pregnancy do not indicate any adverse
foetal or maternal outcomes attributable to REPEVAX. The administration of
REPEVAX to a pregnant woman should be on the basis of official

recommendations or on an individual assessment of the benefits versus the
risks.
Breastfeeding
The effect of administration of REPEVAX during lactation has not been
assessed. Nevertheless, as REPEVAX contains toxoids or inactivated antigens,
no risk to the breastfed infant should be expected. The benefits versus the risk
of administering REPEVAX to breastfeeding women should be evaluated by
the health-care providers.
Fertility
REPEVAX has not been evaluated in fertility studies.

4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed.
REPEVAX has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects
Summary of the safety profile
In clinical trials REPEVAX was given to a total of 1,384 persons including
390 children 3 through 6 years of age and 994 adolescent and adults. Most
commonly reported reactions following vaccination included local reactions at
the injection site (pain, redness and swelling). These signs and symptoms
usually were mild in intensity and occurred within 48 hours following
vaccination (Adverse Events have been observed within 24 hours and 7 days
following vaccination in children 3 through 6 years). They all resolved without
sequelae.
There was a trend for higher rates of local and systemic reactions in
adolescents than in adults. In both age groups, injection site pain was the most
common adverse reaction.
Late-onset local adverse reactions (i.e. a local adverse reaction which had an
onset or increase in severity 3 to 14 days post-immunization), such as injection
site pain, erythema and swelling occurred in less than 1.2%. Most of the
reported adverse reactions occurred within 24 hours after the vaccination.
In a clinical trial of 843 healthy adolescent males and females 11-17 years of
age, administration of the first dose of Gardasil concomitantly with
REPEVAX showed that there was more injection-site swelling and headache
reported following concomitant administration. The differences observed were

< 10% and in the majority of subjects, the adverse events were reported as
mild to moderate in intensity.
Tabulated list of adverse reactions
Adverse reactions are ranked under headings of frequency using the following
convention:
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), including individual cases
Not known
cannot be estimated from the available data
Table 1 presents adverse reactions observed in clinical trials and also includes
additional adverse events which have been spontaneously reported during the
post-marketing use of REPEVAX worldwide. Adverse events in children were
collected from clinical trials conducted in 3 to 5 years of age and 5 to 6 years
of age. The highest frequency from either study is presented. Because postmarketing adverse events are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to vaccine exposure. Therefore, the frequency
category “Not known” is assigned to these adverse events.
Table 1: Adverse events from clinical trials and worldwide post
marketing experience
System Organ
Class
Blood and
lymphatic system
disorders
Immune system
disorders
Nervous system
disorders

Gastrointestinal
disorders

Skin and
subcutaneous

Frequency

Children 3 through 6
years

Adolescents and
Adults

Not known
Lymphadenopathy*
Not known
Very
common
Common
Not known

Very
common
Common
Not known
Common

Anaphylactic reactions, such as urticaria, face
oedema and dyspnea*
Headache
Headache
Convulsions, Vasovagal Syncope, Guillain Barré
syndrome, Facial Palsy, Myelitis, Brachial
Neuritis, Transient paresthesia/hypoesthesia of
vaccinated limb, Dizziness*
Diarrhoea
Vomiting,
Nausea
Abdominal pain
Rash

Nausea
Diarrhoea, Vomiting

System Organ
Class

Frequency

Children 3 through 6
years

Adolescents and
Adults

system disorders
Musculoskeletal
and connective
tissue disorders

Very
common
Common
Not known
Very
common

Arthralgia/joint
swelling, Myalgia

Arthralgia/joint swelling
Pain in vaccinated limb*
General disorders
Fatigue/Asthenia,
Fatigue/Asthenia,
and administration
Fever†
Chills
site conditions
Injection site pain, Injection site swelling,
Injection site erythema
Common
Irritability, Injection site
Fever†
dermatitis, Injection site
bruising, Injection site
pruritus
Not known Malaise§, Pallor*, Extensive limb swelling‡,
Injection site induration*
*
Post marketing adverse events

Fever was measured as temperature ≥37.5°C in Children groups and
measured as temperature ≥38°C in Adolescents and Adults group

See section c)
§
was observed at a frequency of very common in adolescents and
adults, in studies with COVAXiS (Tdap component of REPEVAX; containing
the same amounts of diphtheria, tetanus and pertussis antigens)
Description of selected adverse reactions
Extensive limb swelling which may extend from the injection site beyond one
or both joints and is frequently associated with erythema, and sometimes with
blisters has been reported following administration of REPEVAX. The
majority of these reactions appeared within 48 hours of vaccination and
spontaneously resolved over an average of 4 days without sequelae.
The risk appears to be dependent on the number of prior doses of d/DTaP
vaccine, with a greater risk following the 4th and 5th doses.
Paediatric population

-

-

The safety profile of REPEVAX in 390 children 3 to 6 years of age as
presented in Table 1 is derived from two clinical studies:
In a clinical study, 240 children were primed at 3, 5 and 12 months of age with
a DTaP vaccine with no additional dose in the second year of life. These
children received REPEVAX at 5 to 6 years of age.
One hundred and fifty children primed at 2, 3, and 4 months of age with a
DTwP vaccine (with no additional dose in the second year of life) received
REPEVAX at 3 to 5 years of age.

In both studies the rates of most systemic adverse events within 7 to 10 days
following vaccination were less than 10%. Only fever (≥37.5°C) and fatigue
were reported in more than 10 % of subjects 3 to 6 years of age. In addition,
irritability was reported in more than 10% of subjects 3 to 5 years of age. (See
Table 1).
Transient severe swelling of the injected upper arm was reported in <1% of
children aged 5 to 6 years.
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 Medicines and Healthcare products
Regulatory Agency (MHRA), Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Not-applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic Group: Vaccine against diphtheria, tetanus, pertussis and
poliomyelitis
ATC Code: J07CA02
Clinical trials
The immune responses of adults, adolescents and children 3 to 6 years of age
one-month after vaccination with REPEVAX are shown in the table below.
The use of REPEVAX in children aged 3 to 5 years is based upon studies in
which REPEVAX was given as the fourth dose (first booster) of diphtheria,
tetanus, pertussis and poliomyelitis vaccines.
Table 2: Immune responses 4 weeks after vaccination

Antigen
Diphtheria

Criteria
0.1 IU/mL

Adults and
Adolescents*
(n = 994)

Children
5-6 years old
† (n = 240)

92.8%

99.4%

Children
3-5 years old

(n = 148)
100%

Antigen

Criteria

Adults and
Adolescents*
(n = 994)

Children
5-6 years old
† (n = 240)

0.1 IU/mL§ 100%
99.5%
Tetanus
Pertussis
5 EU/mL** 99.7%
91.2%
Pertussis Toxoid
5 EU/mL** 99.9%
99.1%
Filamentous
5 EU/mL** 99.6%
100%
Haemagglutinin
5 EU/mL** 99.8%
99.5%
Pertactin
Fimbriae Types 2 and
3
1:8 Dilution 99.9%
100%
Polio 1
1:8 Dilution 100%
100%
Polio 2
1:8 Dilution 100%
100%
Polio 3
*
From the age of 10 years onwards

Primed with DTaP at 3 and 5 months with a booster at 12 months of
age

Primed with DTwP at 2, 3 and 4 months of age
§
Measured by ELISA
**
EU = ELISA units: Antibody levels of >5 EU/mL were postulated as
possible surrogate markers for protection against
pertussis by Storsaeter J. et al, Vaccine 1998;16:1907-16.

Children
3-5 years old

(n = 148)
100%
99.3%
99.3%
100%
100%

100%
100%
100%

The safety and immunogenicity of REPEVAX in adults and adolescents was
shown to be comparable to that observed with a single booster dose of Td
adsorbed or Td Polio adsorbed vaccines containing a similar amount of tetanus
and diphtheria toxoids and inactivated poliovirus types 1, 2 and 3.
The lower response to diphtheria toxoid in adults probably reflected the
inclusion of some participants with an uncertain or incomplete immunization
history.
Serological correlates for protection against pertussis have not been
established. On comparison with data from the Sweden I pertussis efficacy
trials conducted between 1992 and 1996, where primary immunization with
Sanofi Pasteur Limited’s acellular pertussis infant DTaP formulation
confirmed a protective efficacy of 85% against pertussis disease, it is
considered that REPEVAX had elicited protective immune responses.
In a subsequent study, robust immune responses were observed following a
single dose of REPEVAX in UK children 3.5 to 4.0 years of age previously
primed with either an acellular pertussis combination vaccine (DTaP-IPV-Hib)
or whole cell pertussis combination vaccine (DTwP//Hib) and OPV.
Antibody persistence
Pivotal studies conducted with COVAXiS (Tdap component of REPEVAX;
containing the same amounts of diphtheria, tetanus and pertussis antigens)
provide serology follow-up data at 3, 5 and 10 years, in individuals previously

immunized with a single booster dose of COVAXiS. Persistence of
seroprotection to diphtheria and tetanus, and seropositivity to pertussis is
summarised in Table 3.
Table 3: Persistence of Seroprotection/Seropositivity Rates to Diphtheria
and Tetanus in Children, Adolescents and Adults at 3-, 5- and 10- years
following a dose of COVAXiS (Tdap component of REPEVAX) (PPI
Population1)
Childr
en (4-6
years)2
5 years

≥ 0.1

N=128150
86.0

3
years
N=30
0
97.0

≥ 0.01

100.0

≥ 0.1

97.3

Time point
Antibody
Diphtheria
(SN,
IU/mL)
Tetanus
(ELISA,
IU/mL)
Pertussis
(ELISA,
IU/mL)
PT
FHA
PRN
FIM

Adults
(18-64 years)2

Adolescents
(11-17 years)2
5 years
N=204206
95.1

10
years
N=2839
94.9

3 years

10 years

81.2

5
years
N=237
-238
81.1

N=292

100.0

100.0

100.0

95.2

93.7

99.3

100.0

100.0

100.0

99.0

97.1

100.0

N=120136
84.6

Seropositivit
y3

63.3
97.3
85.4
82.1
94.2
89.1
85.8
97.3
100.0 99.5
100.0
99.3
100.0
100.0
95.3
99.7
98.5
100.0
98.6
97.1
99.3
98.7
98.3
99.5
100.0
93.5
99.6
98.5
N = number of subjects with available data; SN: seroneutralisation; ELISA:
Enzyme Linked Immunoassay
1
Eligible subjects for whom immunogenicity data was available for at least
one antigen at the specified time-point.
2
Age at which subjects received a dose of COVAXiS
3
Percentage of subjects with antibodies ≥ 4 EU/mL for PT, FHA and PRN, and
≥ 17 EU/mL for FIM for the 3 year follow-up; ≥ 4 EU/mL for PT, FIM and
PRN, and ≥ 3 EU/mL for FHA for the 5-year and 10-year follow-up
In serology follow-up studies conducted with REPEVAX, seroprotective
antibody levels (≥1:8 dilution) for each poliovirus (type1, 2 and 3) were
maintained in 95% to 100% of the children, adolescents and adults at the 5year follow-up time point, and in 100% of the adolescents at the 10-year
follow-up time point.
Immunogenicity following repeat vaccination
The immunogenicity of COVAXiS (Tdap component of REPEVAX)
following repeat vaccination 10 years after a previous dose of COVAXiS or
REPEVAX, has been evaluated. One month post-vaccination ≥ 98.5% of study

participants achieved seroprotective antibody levels (≥ 0.1 IU/ml) for
diphtheria and tetanus, and ≥ 84% achieved booster responses to the pertussis
antigens. (A pertussis booster response was defined as a post-vaccination
antibody concentration ≥ 4 times the LLOQ if the pre-vaccination level was
< LLOQ; ≥ 4 times the pre-vaccination level if that was ≥ LLOQ but < 4 times
LLOQ; or ≥ 2 times the pre-vaccination level if that was ≥ 4 times the LLOQ).
Based on the serology follow-up and repeat vaccination data, REPEVAX can
be used instead of a dT vaccine or dT-IPV vaccine to boost immunity to
pertussis in addition diphtheria, tetanus and polio.

Immunogenicity in naïve subjects






After administration of one dose of REPEVAX to 330 adults ≥40 years of age
that had not received any diphtheria- and tetanus-containing vaccine in the
past 20 years:
≥95.8% of adults were seropositive (≥ 5 IU/mL) for antibodies to all vaccinecontaining pertussis antigens,
82.4% and 92.7% were seroprotected against diphtheria at a threshold ≥0.1
and ≥0.01 IU/mL, respectively,
98.5% and 99.7% were seroprotected against tetanus at a threshold ≥0.1 and
≥0.01 IU/mL, respectively,
and ≥98.8% were seroprotected against polio (types 1, 2 and 3) at a threshold
≥1:8 dilution.
After administration of two additional doses of diphtheria- tetanus- and poliocontaining vaccine to 316 subjects, one and six months after the first dose, the
seroprotection rates against diphtheria were 94.6% and 100% (≥0.1 and ≥
0.01 IU/mL, respectively), against tetanus 100% (≥0.1 IU/mL), and against
polio (types 1, 2 and 3) 100% (≥1:8 dilution) (see Table 4).

Table 4: Serological immune status (seroprotection/seroresponse rates
and GMC/GMT) before vaccination and after each dose of a 3 dosevaccination schedule including REPEVAX® (Dose 1) followed by 2 doses
of REVAXIS® 1 and 6 months later (Dose 2 and 3) in subjects vaccinated
according to protocol (FAS)
Antigen

Criteria

Diphtheria
(SN, IU/mL)

GMC
95%CI
≥0.1
95%CI
≥0.01
95%CI
GMC

Tetanus

Prevaccination
N=330
0.059
[0.046; 0.077]
44.5%
[39.1; 50.1]
72.4%
[67.3; 77.2]
0.48

Post-dose 1
REPEVAX®
N=330
0.813
[0.624; 1.059]
82.4%
[77.9; 86.4]
92.7%
[89.4; 95.3]
6.82

Post-dose 2
REVAXIS®
N=325
1.373
[1.100; 1.715]
90.5%
[86.7; 93.4]
96.0%
[93.3; 97.9]
7.60

Post-dose 3
REVAXIS®
N=316
1.489
[1.262; 1.757]
94.6%
[91.5; 96.8]
100%
[98.8; 100]
5.46

(ELISA,
IU/mL)

95%CI

≥0.1
95%CI
≥0.01
95%CI
Poliomyelitis (SN, 1/dil)
GMT
Type 1
95%CI

Type 2

Type 3

[0.39;0.60]

[5.92;7.87]

[6.77;8.52]

[5.01;5.96]

81.2%
[76.6; 85.3]
92.4%
[89.0; 95.0]

98.5%
[96.5; 99.5]
99.7%
[98.3; 100]

100%
[98.9; 100]
100%
[98.9; 100]

100%
[98.8; 100]
100%
[98.8; 100]

162.6
[133.6; 198.0]

2869.0
[2432.9;
3383.4]
99.4%
[97.8; 99.9]
3829.7
[3258.5;4501.1
]
100%
[98.9; 100]
5011.4
[4177.4;
6012.0]
98.8%
[96.9; 99.7]

2320.2
[2010.9;
2677.0]
100%
[98.9; 100]
3256.0
[2818.2;3761.7
]
100%
[98.9; 100]
3615.6
[3100.5;
4216.4]
99.7%
[98.3; 100]

1601.9
[1425.4;
1800.3]
100%
[98.8; 100]
2107.2
[1855.7;2392.8
]
100%
[98.8; 100]
2125.8
[1875.5;
2409.6]
100%
[98.8; 100]

≥8
95%CI
GMT
95%CI

93.3%
[90.1; 95.8]
164.5
[137.6;196.8]

≥8
95%CI
GMT
95%CI

95.5%
[92.6; 97.4]
69.0
[56.9; 83.6]

≥8
89.1%
95%CI
[85.2; 92.2]
Pertussis (ELISA, EU/mL)
GMC
7.7
41.3
PT
95%CI
[6.8; 8.7]
[36.7; 46.5]
≥5
96.3%
95%CI
[93.6; 98.1]
GMC
28.5
186.7
FHA
95%CI
[25.5; 31.8]
[169.6; 205.6]
≥5
100%
95%CI
[98.9; 100]
GMC
7.7
328.6
PRN
95%CI
[6.7; 8.9]
[273.0; 395.6]
≥5
99.4%
95%CI
[97.8; 99.9]
GMC
6.1
149.6
FIM2&3
95%CI
[5.2; 7.1]
[123.6; 181.0]
≥5
95.8%
95%CI
[93.0; 97.7]
GMC: Geometric mean of antibody concentrations; GMT: Geometric mean of
antibody titres; CI: Confidence Interval; SN: seroneutralisation; ELISA:
Enzyme Linked Immunoassay; dil: dilution
FAS: Full Analysis Set – includes all subjects who received the study vaccine
dose and for whom the post-vaccination immunogenicity evaluation was
available.

5.2

Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.

5.3

Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional
studies of repeated doses toxicity.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Phenoxyethanol
Polysorbate 80
Water for injections

6.2

Incompatibilities
In the absence of compatibility studies, REPEVAX® must not be mixed with
any vaccine or other medicinal products.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Store in a refrigerator at 2°C to 8°C.
Do not freeze. Discard the vaccine if it has been frozen.
Keep the container in the outer carton in order to protect from light.

6.5

Nature and contents of container
0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper
(chlorobromobutyl or bromobutyl or chlorobutyl elastomer), without attached

needle, with a tip-cap (chlorobromobutyl elastomer or synthetic isoprenebromobutyl elastomer) - pack size of 1, 10 or 20.
0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper
(chlorobromobutyl or bromobutyl or chlorobutyl elastomer), without attached
needle, with a tip-cap (chlorobromobutyl elastomer or synthetic isoprenebromobutyl elastomer) and 1 or 2 separate needles - pack size of 1 or 10.
0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper
(chlorobromobutyl or bromobutyl or chlorobutyl elastomer) with attached
needle and needle guard (translucent polypropylene rigid safeshield and
polyisoprene) - pack size of 1, 10 or 20.
The stoppers, plunger stoppers and caps for all presentations of REPEVAX are
latex-free.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Instructions for use
Parenteral products should be inspected visually for extraneous particulate
matter and/or discoloration prior to administration. In the event of either being
observed, discard the medicinal product.
The normal appearance of the vaccine is a uniform cloudy, white suspension
which may sediment during storage. Shake the prefilled syringe well to
uniformly distribute the suspension before administering the vaccine.
For needle free syringes, the needle should be pushed firmly on to the end of
the prefilled syringe and rotated through 90 degrees.
Disposal
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
Needles should not be recapped.

7

MARKETING AUTHORISATION HOLDER
Sanofi Pasteur Europe
2 Avenue Pont Pasteur

69007 Lyon
FRANCE

8

MARKETING AUTHORISATION NUMBER(S)
PL 46602/0005

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/12/2006

10

DATE OF REVISION OF THE TEXT
01/11/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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