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ACWY Vax Vaccine

Last Updated on eMC 14-Mar-2014 View changes  | GlaxoSmithKline UK Contact details

1. Name of the medicinal product

ACWY Vax® - powder and solvent for solution for injection in a pre-filled syringe

Meningococcal polysaccharide groups A, C, Y and W135 vaccine

2. Qualitative and quantitative composition

After reconstitution, 1 dose (0.5 ml) contains:

Neisseria meningitidis group A polysaccharide

50 µg

Neisseria meningitidis group C polysaccharide

50 µg

Neisseria meningitidis group Y polysaccharide

50 µg

Neisseria meningitidis group W135 polysaccharide

50 µg

Excipients with known effect :

This product contains sodium 77 micromol per dose (see section 4.4)

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Powder and solvent for solution for injection in a pre-filled syringe.

The powder is white. The solvent is clear and colourless.

4. Clinical particulars
4.1 Therapeutic indications

Active immunisation of children older than 2 years, adolescents and adults against invasive meningococcal disease caused by meningococci of groups A, C, W135 and Y.

ACWY Vax should be used in accordance with available official recommendations.

4.2 Posology and method of administration

Posology

One dose of 0.5 ml.

Subjects who remain at increased risk of invasive meningococcal disease may be revaccinated at intervals (see persistence of immune response in section 5.1). Intervals should be in accordance with available official recommendations.

Paediatric population

The safety and efficacy of ACWY Vax in children up to 2 years of age have not been established.

Method of administration

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

ACWY Vax is for deep subcutaneous injection only.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Hypersensitivity after previous administration of ACWY Vax.

As with other vaccines, the administration of ACWY Vax should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contra-indication for immunisation.

4.4 Special warnings and precautions for use

As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine.

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.

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.

ACWY Vax should under no circumstances be administered intravascularly or intradermally.

ACWY Vax will only confer protection against Neisseria meningitidis groups A, C, W135 and Y. Protection cannot be guaranteed in every individual vaccinated.

The vaccine may not elicit a protective immune response in subjects with impaired immune systems.

Group C, W135 and Y polysaccharides are poorly immunogenic in children less than 24 months of age. Group A polysaccharide induces an antibody response in children from the age of 6 months. However, the response is lower than that observed in older subjects and may be transient.

Group C polysaccharide may induce immunological hyporesponsiveness to further doses of polysaccharide C or to meningococcal group C conjugate vaccine. The clinical relevance of this phenomenon remains unknown.

In subjects remaining at high risk of exposure to meningococcal disease caused by groups A, C, W135 and Y, re-vaccination should be considered according to official recommendations (see section 5.1).

The solvent of the vaccine contains less than 1mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

4.5 Interaction with other medicinal products and other forms of interaction

There are no data on concomitant administration of ACWY Vax and other vaccines.

Different injection sites should be used when concomitant administration with other injectable vaccines cannot be avoided.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data from the use of ACWY Vax in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

ACWY Vax should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.

Breastfeeding

It is unknown whether ACWY Vax is excreted in human milk.

ACWY Vax should only be used during breast-feeding when the possible advantages outweigh the potential risks.

Fertility

No fertility data are available.

4.7 Effects on ability to drive and use machines

ACWY Vax may cause drowsiness or dizziness. Those effects may affect the ability to drive or operate machinery.

4.8 Undesirable effects

In recent clinical studies, ACWY Vax was administered to 502 subjects.

The most commonly reported adverse reactions were pain at the injection site and redness at the injection site.

Adverse reactions occurring during these studies were mostly reported within 48 hours following vaccination.

Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows:-

Frequencies are reported as:

Very common: (≥1/10)

Common: (≥1/100 to <1/10)

Uncommon: (≥ 1/1,000 to <1/100)

Metabolism and nutrition disorders:

Common: loss of appetite

Psychiatric disorders:

Common: irritability

Nervous system disorders:

Very Common: headache

Common: drowsiness

Uncommon: dizziness

Gastrointestinal disorders:

Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhoea

Skin and subcutaneous tissue disorders:

Uncommon: urticaria, rash

General disorders and administration site conditions:

Very common: pain, redness at the injection site, fatigue

Common: fever, swelling at the injection site

In a WHO study conducted in Ghana, ACWY Vax was administered to 177 adults. The following adverse reactions were observed in this trial:

Very common: tenderness at injection site

Common: induration at injection site.

In addition, the following adverse reactions have been reported during post-marketing surveillance:

Immune system disorders:

Allergic reactions, including anaphylactic and anaphylactoid reactions

Skin and subcutaneous tissue disorders:

Angioneurotic oedema

Musculoskeletal and connective tissue disorders:

Arthralgia, musculoskeletal stiffness

General disorders and administration site conditions:

Influenza-like symptoms, chills

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Cases of overdose (up to 10 times the recommended dose) have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Bacterial vaccines, ATC code: J07AH04

Immunogenicity data

ACWY Vax induces bactericidal antibodies against meningococci of groups A, C, W135 and Y.

The current formulation of ACWY Vax was shown immunologically non-inferior to the previous formulation of the vaccine in a trial conducted in Lebanon in 161 subjects aged 2-30 years.

The immunogenicity of the previous formulation of ACWY Vax was evaluated in four clinical studies conducted in Belgium, Lebanon, Poland and Taiwan (N =341) in subjects aged 2-30 years.

Antibody titres were measured with the serum bactericidal assay using rabbit complement (rSBA) at GSK laboratories.

Vaccine response was defined as seroconversion for initially seronegative subjects (with SBA titre below 1:8) or as four-fold increase in rSBA titre from pre to post vaccination for initially seropositive subjects.

The percentage of vaccine responders observed in the four clinical studies conducted with the previous formulation were as follows:

In children aged 2-5 years: Group A - 69.1%, Group C - 93.1%, Group W135 - 89.3%, Group Y - 79.2%.

In subjects aged 6-30 years: Group A - 72.2%, Group C - 95.4%, Group W135 - 92.3%, Group Y -81.2%.

In initially seronegative subjects seroconversion rates were 100% for Group A and Y, and at least 92.9% for Group C and W135.

The risk of meningococcal disease is much higher in individuals with late complement component deficiency (LCCD) because of their inability to kill meningococci via the classical and alternative pathways. However, ACWY Vax induces anti-capsular polysaccharide antibodies against each of the four groups in LCCD subjects. In spite of the complement deficiency, killing of meningococci A, C, W135 and Y is observed when sera from LCCD subjects vaccinated with ACWY Vax are incubated with human neutrophils.

Efficacy data

In response to a meningococcal disease epidemic in Burkina Faso, a mass vaccination campaign with Mencevax ACW was performed in more than 1.68 million children and adults aged from 2 to 29 years. The vaccine effectiveness against group A and W135 disease was 95.8% (95% CI: 81.8%-99.0%) for persons with reported vaccination.

Persistence of immune response

The persistence of the immune response elicited by Mencevax ACWY was evaluated up to 5 years after vaccination in adolescents and adults aged 11-55 years primed in study MenACWY-TT-015 conducted in the Philippines and Saudi Arabia (Table 1). The rSBA data generated at Public Health England (PHE) laboratories, indicate that among individuals 11-55 years of age who were vaccinated two years earlier with Mencevax ACWY, immunity to groups W-135 and Y persists in 24.0% and 44.0%, respectively.

The persistence of the immune response elicited by Mencevax ACWY was evaluated 12 months after vaccination in children aged 2-10 years in study MenACWY-TT-027 conducted in Finland (Table 2) and up to 15 months after vaccination in children aged 3-5 years in study MenACWY-TT-013 conducted in Austria and Germany (Table 3). Limited data from these two clinical studies showed a waning of serum bactericidal antibody titres one year post-vaccination when using human complement in the assay (hSBA).

The clinical relevance of the waning of antibody titres is unknown and data suggest that revaccination may be appropriate for individuals who remain at high risk of exposure to Neisseria meningitides. Use of conjugate vaccines is recommended when revaccination within two years after administration of the previous Mencevax ACWY dose. The risk of hyporesponsiveness precludes the use of non-conjugated polysaccharide vaccines within this time-period.

Table 1: 5 year persistence data (rSBA) in adolescents and adults aged 11-55 years at vaccination

Group

Time-point

N*

rSBA** ≥1:8

(95%CI)

GMT

(95%CI)

A

Mencevax ACWY

Month 1

19

100%

(82.4; 100)

1463.2

(886.5; 2415.0)

Year 1

19

84.2%

(60.4; 96.6)

218.0

(71.0; 669.6)

Year 2

98

91.8%

(84.5; 96.4)

385.8

(259.4; 573.9)

Year 4

107

73.8%

(64.4; 81.9)

105.4

(67.6; 164.4)

Year 5

105

74.3%

(64.8; 82.3)

103.6

(67.8; 158.3)

MenACWY-TT

Month 1

30

100%

(88.4; 100)

4231.2

(2730.0; 6556.2)

Year 1

30

93.3%

(77.9; 99.2)

1066.9

(472.4; 2409.6)

Year 2

99

94.9%

(88.6; 98.3)

807.1

(559.5; 1164.2)

Year 4

312

86.5%

(82.2; 90.1)

278.6

(219.7; 353.2)

Year 5

299

90.0%

(86.0; 93.1)

303.9

(248.2; 372.0)

C

Mencevax ACWY

Month 1

18

100%

(81.5; 100)

8070.7

(4896.6; 13302.2)

Year 1

17

94.1%

(71.3; 99.9)

1956.8

(731.8; 5232.7)

Year 2

99

86.9%

(78.6-92.8)

286.3

(181.8; 450.9)

Year 4

107

84.1%

(75.8; 90.5)

315.0

(196.8; 504.1)

Year 5

104

71.2%

(61.4; 79.6)

142.4

(85.3; 237.6)

MenACWY-TT

Month 1

30

100%

(88.4; 100)

6886.0

(4473.9; 10598.7)

Year 1

30

96.7%

(82.8; 99.9)

462.7

(239.2; 895.2)

Year 2

100

98.0%

(93.0; 99.8)

304.4

(232.0; 399.5)

Year 4

312

88.5%

(84.4; 91.8)

273.6

(220.6; 339.4)

Year 5

299

79.3%

(74.2; 83.7)

114.0

(90.5; 143.5)

W-135

Mencevax ACWY

Month 1

17

76.5%

(50.1; 93.2)

881.6

(150.8; 5154.0)

Year 1

18

66.7%

(41.0; 86.7)

120.3

(23.6; 614.5)

Year 2

100

24%

(16.0; 33.6)

6.5

(4.2; 10.0)

Year 4

107

25.2%

(17.3; 34.6)

11.3

(7.8; 16.3)

Year 5

105

24.8%

(16.9; 34.1)

11.7

(7.9; 17.1)

MenACWY-TT

Month 1

30

96.7%

(82.8; 99.9)

9571.6

(4649.0; 19706.4)

Year 1

30

93.3%

(77.9; 99.2)

1659.2

(728.5; 3778.7)

Year 2

100

84.0%

(75.3; 90.6)

257.8

(161.8; 410.7)

Year 4

312

74.0%

(68.8; 78.8)

175.1

(131.5; 233.0)

Year 5

299

71.6%

(66.1; 76.6)

170.2

(124.7; 232.4)

Y

Mencevax ACWY

Month 1

12

100%

(73.5; 100)

2663.0

(1821.9; 3892.4)

Year 1

12

50.0%

(21.1; 78.9)

22.3

(3.4; 146.2)

Year 2

100

44.0%

(34.1; 54.3)

19.4

(11.4; 33.0)

Year 4

107

43.9%

(34.3; 53.9)

26.0

(16.6; 40.7)

Year 5

105

44.8%

(35.0; 54.8)

29.6

(18.7; 46.7)

MenACWY-TT

Month 1

27

100%

(87.2; 100)

3659.5

(2193.4; 6105.6)

Year 1

28

96.4%

(81.7; 99.9)

1157.7

(572.2; 2342.3)

Year 2

100

86.0%

(77.6; 92.1)

367.1

(232.2; 580.2)

Year 4

309

82.8%

(78.2; 86.9)

350.5

(268.9; 456.7)

Year 5

299

84.3%

(79.7; 88.2)

306.0

(236.3; 396.3)

GMT: Geometric Mean Titre

MenACWY-TT: Meningococcal group A, C, W-135 and Y vaccine conjugated to tetanus toxoid

* For one Month 1, Year 1 and Year 2 post-vaccination time points, a subset of samples were tested with PHE rSBA assays

**rSBA testing performed at PHE laboratories in UK

Table 2: 1 year persistence data (hSBA) in children aged 2 to 10 years at vaccination

Group

Response to

Time-point

hSBA*

N

≥4

(95%CI)

GMT

(95%CI)

A

Mencevax ACWY

Month 1

35

25.7%

(12.5; 43.3)

4.1

(2.6; 6.5)

Year 1

35

11.4%

(3.2; 26.7)

2.5

(1.9; 3.3)

MenACWY-TT

Month 1

111

82.0%

(73.6; 88.6)

57.0

(40.3; 80.6)

Year 1

104

18.3%

(11.4; 27.1)

3.5

(2.7; 4.4)

C

Mencevax ACWY

Month 1

38

39.5%

(24.0; 56.6)

13.1

(5.4; 32.0)

Year 1

31

32.3%

(16.7; 51.4)

7.7

(3.5; 17.3)

MenACWY-TT

Month 1

107

89.7%

(82.3; 94.8)

154.8

(101.1; 237.1)

Year 1

105

95.2%

(89.2; 98.4)

129.5

(95.4; 175.9)

W-135

Mencevax ACWY

Month 1

35

34.3%

(19.1; 52.2)

5.8

(3.3; 9.9)

Year 1

31

12.9%

(3.6; 29.8)

3.4

(2.0; 5.8)

MenACWY-TT

Month 1

107

95.3%

(89.4; 98.5)

134.2

(101.4; 177.6)

Year 1

103

100%

(96.5; 100)

256.7

(218.2; 301.9)

Y

Mencevax ACWY

Month 1

32

43.8%

(26.4; 62.3)

12.5

(5.6; 27.7)

Year 1

36

33.3%

(18.6; 51.0)

9.3

(4.3; 19.9)

MenACWY-TT

Month 1

94

84.0%

(75.0; 90.8)

93.7

(62.1; 141.4)

Year 1

106

99.1%

(94.9; 100)

265.0

(213.0; 329.6)

The analysis of immunogenicity was conducted on ATP cohort adapted for each time-point.

GMT: Geometric Mean Titre

MenACWY-TT: Meningococcal group A, C, W-135 and Y vaccine conjugated to tetanus toxoid

* hSBA testing performed at GSK laboratories

Table 3: 15 months persistence data (hSBA) in children aged 3 to 5 years at vaccination

Group

Response to

Time-point

hSBA*

N

≥4

(95%CI)

GMT

(95%CI)

A

Mencevax ACWY

Month 1

26

42.3%

(23.4; 63.1)

5.9

(3.2; 11.0)

Month 15

14

7.1%

(0.2; 33.9)

2.2

(1.8; 2.7)

MenACWY-TT

Month 1

42

83.3%

(68.6; 93.0)

23.7

(14.8; 38.1)

Month 15

24

20.8%

(7.1; 42.2)

3.5

(2.2; 5.7)

C

Mencevax ACWY

Month 1

14

92.9%

(66.1; 99.8)

25.7

(12.6; 52.7)

Month 15

22

77.3%

(54.6; 92.2)

28.1

(12.9; 61.0)

MenACWY-TT

Month 1

23

95.7%

(78.1; 99.9)

95.0

(53.6; 168.5)

Month 15

35

94.3%

(80.8; 99.3)

112.4

(70.2; 180.0)

W-135

Mencevax ACWY

Month 1

22

63.6%

(40.7; 82.8)

49.6

(14.9; 165.4)

Month 15

6

33.3%

(4.3; 77.7)

8.1

(0.8; 79.7)

MenACWY-TT

Month 1

40

90.0%

(76.3; 97.2)

284.0

(154.5; 522.0)

Month 15

24

95.8%

(78.9; 99.9)

221.5

(136.8; 358.7)

Y

Mencevax ACWY

Month 1

28

53.6%

(33.9; 72.5)

10.8

(5.3; 21.9)

Month 15

19

63.2%

(38.4; 83.7)

20.9

(7.4; 58.9)

MenACWY-TT

Month 1

38

92.1%

(78.6; 98.3)

55.7

(35.9; 86.5)

Month 15

32

90.6%

(75.0; 98.0)

92.3

(48.6; 175.1)

The analysis of immunogenicity was conducted on ATP cohort adapted for each time-point.

GMT: Geometric Mean Titre

MenACWY-TT: Meningococcal group A, C, W-135 and Y vaccine conjugated to tetanus toxoid

*hSBA testing performed at GSK laboratories

5.2 Pharmacokinetic properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.

6. Pharmaceutical particulars
6.1 List of excipients

Powder :

Sucrose

Trometamol

Solvent:

Sodium chloride

Water for injections

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.

After reconstitution, the vaccine should be used immediately. However, chemical and physical in-use stability has been demonstrated for 8 hours at 2-8°C.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Store in the original package in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Powder in a vial (type I glass) with a stopper and solvent (0.5 ml) in a pre-filled syringe (type I glass) with a stopper with or without needles– pack size of 1.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The vaccine should be inspected visually for any foreign particulate matter and/or other coloration prior to administration. In the event of either being observed, discard the vaccine.

ACWY Vax must be reconstituted by adding the entire content of the supplied container of solvent to the vial containing the powder. The powder should be completely dissolved in the solvent. The reconstituted vaccine is a clear colourless solution.

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 10592/0301

9. Date of first authorisation/renewal of the authorisation

23 June 2008/10 August 2012

10. Date of revision of the text

24 February 2014

POM

Discontinued Items
VIEW

The preparations being discontinued are:

  • ACWY Vax vaccine powder and solvent for solution for injection 0.5ml vials (GlaxoSmithKline UK Ltd)

The pharmaceutical company has decided to discontinue the product and so it may not be available in the future.  This document has been left on the eMC for information purposes.

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Company contact details

GlaxoSmithKline UK

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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

acwy meningococcal polysaccharide

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