Trumenba

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.

1. NAME OF THE MEDICINAL PRODUCT

Trumenba suspension for injection in pre-filled syringe

Meningococcal group B vaccine (recombinant, adsorbed)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 dose (0.5 ml) contains:

Neisseria meningitidis serogroup B fHbp subfamily A1,2,3 60 micrograms

Neisseria meningitidis serogroup B fHbp subfamily B1,2,3 60 micrograms

1 Recombinant lipidated fHbp (factor H binding protein)
2 Produced in Escherichia coli cells by recombinant DNA technology
3 Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.
White liquid suspension.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive 
meningococcal disease caused by Neisseria meningitidis serogroup B.

See section 5.1 for information on the immune response against specific serogroup B strains.

The use of this vaccine should be in accordance with official recommendations.

4.2 Posology and method of administration

Posology

Primary series
2 doses: (0.5 ml each) administered at a 6 month interval (see section 5.1).

3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least
4 months after the second dose (see section 5.1).



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Booster dose
A booster dose should be considered following either dosing regimen for individuals at continued risk 
of invasive meningococcal disease (see section 5.1).

Other paediatric populations
Safety and efficacy of Trumenba in children younger than 10 years of age have not been established.
Currently available data for children 1 to 9 years of age are described in sections 4.8 and 5.1; however,
no recommendation on a posology can be made as data are limited.

Method of administration

For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper 
arm.

For instructions on the handling of the vaccine before administration, see section 6.6.

There are no data available on the interchangeability of Trumenba with other meningococcal group B 
vaccines to complete the vaccination series.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

In order to improve the traceability of biological medicinal products, the tradename and batch number 
of the administered product should be clearly recorded.

Appropriate medical treatment and supervision should always be readily available in case of an 
anaphylactic event following the administration of the vaccine.

As with other injectable vaccines, syncope (fainting) can occur in association with administration of 
Trumenba. Procedures should be in place to avoid injury from fainting.

Vaccination should be postponed in individuals suffering from an acute severe febrile illness. 
However, the presence of a minor infection, such as cold, should not result in the deferral of 
vaccination.

Do not inject intravenously, intradermally, or subcutaneously.

Trumenba should not be given to individuals with thrombocytopenia or any coagulation disorder that 
would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of 
administration.

Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons 
receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at 
increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop 
antibodies following vaccination with Trumenba.

As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients. 

Limitations of clinical trials
There are no data on the use of Trumenba in immunocompromised individuals. Immunocompromised 
individuals, including individuals receiving immunosuppressant therapy, may have a diminished 
immune response to Trumenba.



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There are limited data on the use of Trumenba in individuals 40 to 65 years of age and there are no 
data on the use of Trumenba in individuals older than 65 years of age.

4.5 Interaction with other medicinal products and other forms of interaction

Trumenba can be given concomitantly with any of the following vaccines: Tetanus Toxoid, Reduced 
Diphtheria Toxoid, Acellular Pertussis, and Inactivated Poliovirus Vaccine (TdaP-IPV), Quadrivalent 
Human Papillomavirus vaccine (HPV4), Meningococcal Serogroups A, C, W, Y conjugate vaccine 
(MenACWY) and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine 
Adsorbed (Tdap).

When given concomitantly with other vaccines Trumenba must be administered at a separate injection
site.

Trumenba should not be mixed with other vaccines in the same syringe.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of Trumenba in pregnant women. The potential risk for pregnant 
women is unknown. Nevertheless, vaccination should not be withheld when there is a clear risk of 
exposure to meningococcal infection.

Reproduction studies performed in female rabbits have revealed no evidence of impaired female 
fertility or harm to the foetus due to Trumenba. 

Breast-feeding

It is unknown whether Trumenba is excreted in human milk. Trumenba should only be used during 
breast-feeding when the possible advantages outweigh the potential risks.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see 
section 5.3).

Trumenba has not been evaluated for impairment of fertility in males.

4.7 Effects on ability to drive and use machines

Trumenba has no or negligible influence on the ability to drive and use machines. However, some of 
the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

4.8 Undesirable effects

Summary of the safety profile

The safety profile presented is based on analysis of over 15,500 subjects (1 year of age and older) who 
have been vaccinated with at least 1 dose of Trumenba in completed clinical studies. 

In over 15,000 individuals ≥ 10 years of age studied, the most common adverse reactions were
headache, diarrhoea, nausea, muscle pain, joint pain, fatigue, chills, and injection site pain, swelling 
and redness.



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Adverse reactions following booster vaccination in 301 subjects 15 to 23 years of age were similar to 
adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.

List of adverse reactions

Adverse reactions reported in clinical studies of subjects 10 years of age and older are listed in 
decreasing order of frequency and seriousness.

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) 
Not known (cannot be estimated from available data)

Immune system disorder
Not known: Allergic reactions*

Nervous system disorders
Very Common: Headache

Gastrointestinal disorders
Very Common: Diarrhoea; nausea
Common: Vomiting

Musculoskeletal and connective tissue disorders
Very Common: Muscle pain (myalgia); joint pain (arthralgia)

General disorders and administration site conditions
Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site
Common: Fever ≥ 38 °C (Pyrexia)

* The following is considered an adverse reaction for Trumenba and was reported in the 
postmarketing experience. Because this reaction was derived from spontaneous reports, the frequency 
could not be determined and is thus considered as not known.

In a study of 220 toddlers 1 to < 2 years of age, the following adverse reactions occurred at a 
frequency of very common (≥ 1/10): drowsiness, irritability (fussiness), loss of or decreased appetite, 
fever, and injection site pain, swelling and redness.

In a study of 294 children 2 to 9 years of age, the following adverse reactions occurred at a frequency 
of very common (≥ 1/10): headache, diarrhoea, vomiting, muscle pain, joint pain, fever, fatigue, and
injection site pain, swelling and redness.

In clinical studies, fever (≥ 38°C) occurred more frequently as subject age decreased. Of subjects 1 to 
< 2 years of age, 37.3% reported fever; of subjects 2 to 9 years of age, 24.5% reported fever; of 
subjects 10 to 18 years of age, 9.8% reported fever; and of subjects 18 to 25 years of age, 4.4% 
reported fever. Fever followed a predictable pattern after vaccination: onset occurred within 2 to 
4 days, lasted 1 day, and was mild to moderate in severity. Fever rate and severity tended to decrease 
with subsequent Trumenba vaccinations.

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 national reporting system 
listed in Appendix V.

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose

Experience of overdose is limited. In the event of overdose, monitoring of vital functions and possible 
symptomatic treatment is recommended.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: vaccines; ATC code: J07AH09

Mechanism of action

Trumenba is a vaccine composed of 2 recombinant lipidated factor H binding protein (fHbp) variants. 
fHbp is found on the surface of meningococcal bacteria and is essential for bacteria to avoid host 
immune defenses. fHbp variants segregate into 2 immunologically distinct subfamilies, A and B, and 
over 96% of meningococcal serogroup B isolates in Europe express fHbp variants from either 
subfamily on the bacterial surface.

Immunisation with Trumenba, which contains one fHbp variant each from subfamily A and B, is 
intended to stimulate the production of bactericidal antibodies that recognize fHbp expressed by 
meningococci. The Meningococcal Antigen Surface Expression (MEASURE) assay was developed to 
relate the level of fHbp surface expression to killing of meningococcal serogroup B strains in serum 
bactericidal assays with human complement (hSBAs). A survey of over 2,150 different invasive 
meningococcal serogroup B isolates collected from 2000-2014 in 7 European countries, the US and 
Canada demonstrated that over 91% of all meningococcal serogroup B isolates expressed sufficient 
levels of fHbp to be susceptible to bactericidal killing by vaccine-induced antibodies.

Clinical efficacy 

The efficacy of Trumenba has not been evaluated through clinical trials. Vaccine efficacy has been 
inferred by demonstrating the induction of serum bactericidal antibody responses to 4 meningococcal 
serogroup B test strains (see the Immunogenicity section). The 4 test strains express fHbp variants 
representing the 2 subfamilies (A and B) and, when taken together, are representative of
meningococcal serogroup B strains causing invasive disease. 

Immunogenicity 

Protection against invasive meningococcal disease is mediated by serum bactericidal antibodies to 
bacterial surface antigens. Bactericidal antibodies act in concert with human complement to kill 
meningococci. This process is measured in vitro with hSBA for meningococcal serogroup B. An 
hSBA titre of greater than or equal 1:4 is assumed to be protective against meningococcal disease. In 
the immunogenicity analysis for Trumenba, a response was defined as an hSBA titre of at least 1:8 or 
1:16 depending on the hSBA strain. A 4-fold increase in hSBA titre for each of the 4 primary 
meningococcal serogroup B test strains was defined as follows: (1) For subjects with a baseline hSBA 
titre < 1:4, a 4-fold response was defined as an hSBA titre ≥ 1:16. (2) For subjects with a baseline 
hSBA titre ≥ 1:4, a 4-fold response was defined as an hSBA titre ≥ 4 times the lower limit of 
quantitation or ≥ 4 times the baseline titre, whichever was higher. A composite response was defined 
as a response for all 4 hSBA strains combined.

Immunogenicity in individuals 10 years of age and older

The immunogenicity of Trumenba following 2 or 3 vaccinations was evaluated in individuals 11 to 
18 years of age in Europe (Study B1971012) and following 3 vaccinations in individuals 10 to 
25 years of age globally (Studies B1971009 and B1971016). 



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In Study B1971012, Trumenba was administered according to the following schedules: Group 1 (0, 1, 
and 6 months); Group 2 (0, 2, and 6 months); Group 3 (0 and 6 months); Group 4 (0 and 2 months); 
Group 5 (0 and 4 months). Of the 1,713 subjects randomised, 427 were in Group 1, 430 were in 
Group 2, 427 were in Group 3, 286 were in Group 4, and 143 were in Group 5. All subjects received 
4 study injections, either 2 or 3 doses of Trumenba and 1 or 2 doses of saline. The hSBA responses 
observed after the second or third dose for Groups 1, 2, and 3 are presented in Tables 1 and 2.

For the second and third doses, serum was obtained approximately 1 month after the second or third 
vaccination dose.

Table 1: Immune Responses Among Individuals 11 to 18 Years of Age Administered 
Trumenba After Various 2- and 3-Dose Schedules (Study B1971012)

Group 1 Group 2 Group 3
(0, 1, and 6 Months) (0, 2, and 6 Months) (0 and 6 Months)
N %

(95% CI)
N %

(95% CI)
N %

(95% CI)
hSBA Strain (fHbp
Variant)
                        Dose

PMB80 
(A22)

% hSBA ≥ 1:16 

Dose 2 351
73.5

(68.6, 78.0)
344

88.1
(84.2, 91.3)

369
93.2

(90.2, 95.6)

Dose 3 360
91.4

(88.0, 94.1)
357

95.0
(92.1, 97.0)

-- --

≥ 4-Fold rise in hSBA titre (%)

Dose 2 343
55.7

(50.3, 61.0)
336

73.8
(68.8, 78.4)

362
80.7

(76.2, 84.6)

Dose 3 351
78.1

(73.4, 82.3)
349

84.0
(79.7, 87.6)

-- --

PMB2001 
(A56)

% hSBA ≥ 1:8

Dose 2 353
96.6

(94.1, 98.2)
339

97.9
(95.8, 99.2)

370
98.4

(96.5, 99.4)

Dose 3 362
99.4

(98.0, 99.9)
359

98.9
(97.2, 99.7)

-- --

≥ 4-Fold rise in hSBA titre (%)

Dose 2 338
86.1

(81.9, 89.6)
327

90.5 
(86.8, 93.5)

354
90.4

(86.8, 93.3)

Dose 3 347
93.4

(90.2, 95.8)
347

94.2
(91.2, 96.4)

-- --

PMB2948 
(B24)

% hSBA ≥ 1:8

Dose 2 344
62.2

(56.9, 67.4)
337

70.3
(65.1, 75.2)

359
81.1

(76.6, 85.0)

Dose 3 354
89.0

(85.2, 92.0)
354

88.4
(84.6, 91.6)

-- --

≥ 4-Fold rise in hSBA titre (%)

Dose 2 341
47.2

(41.8, 52.7)
333

54.1
(48.5, 59.5)

357
65.5

(60.4, 70.5)

Dose 3 351
74.6

(69.8, 79.1)
350

75.4
(70.6, 79.8)

-- --

PMB2707 
(B44)

% hSBA ≥ 1:8

Dose 2 341
54.0

(48.5, 59.3)
331

61.9
(56.5, 67.2)

356
77.5

(72.8, 81.8)

Dose 3 356
88.5

(84.7, 91.6)
352

86.1
(82.0, 89.5)

-- --

≥ 4-Fold rise in hSBA titre (%)



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Table 1: Immune Responses Among Individuals 11 to 18 Years of Age Administered 
Trumenba After Various 2- and 3-Dose Schedules (Study B1971012)

Group 1 Group 2 Group 3
(0, 1, and 6 Months) (0, 2, and 6 Months) (0 and 6 Months)
N %

(95% CI)
N %

(95% CI)
N %

(95% CI)

Dose 2 339
43.4

(38.0, 48.8)
328

55.2
(49.6, 60.6)

355
66.8

(61.6, 71.6)

Dose 3 354
82.2

(77.8, 86.0)
349

81.7
(77.2, 85.6)

-- --

Composite response (A response for all 4 hSBA strains combined)
Before 
Dose 1

339
3.5

(1.8, 6.1)
333

2.4
(1.0, 4.7)

345
3.2

(1.6, 5.6)

Dose 2 308
45.1

(39.5, 50.9)
311

54.3
(48.6, 60.0)

343
73.5

(68.5, 78.1)

Dose 3 337
83.1

(78.6, 86.9)
345

81.7
(77.3, 85.7)

-- --

Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding 
protein.
Note: The lower limit of quantitation is an hSBA titre=1:16 for PMB80 (A22) and 1:8 for 
PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).

Table 2: Immune Responses Among Individuals 11 to 18 Years of Age Administered 
Trumenba After Various 2- and 3-Dose Schedules (Study B1971012)

Group 1 Group 2 Group 3
(0, 1, and 6 Months) (0, 2, and 6 Months) (0 and 6 Months)

N
GMT

(95% CI)
N

GMT
(95% CI)

N
GMT

(95% CI)
hSBA Strain 
(fHbp Variant)
                    Dose

PMB80 
(A22) 

hSBA GMT

Dose 2 351
29.0

(26.0, 32.5)
344

35.6
(32.2, 39.4)

369
50.6

(45.9, 55.8)

Dose 3 360
58.4 

(52.4, 64.9)
357

58.3 
(53.2, 63.9)

--

PMB2001 
(A56)

hSBA GMT

Dose 2 353
77.3

(68.5, 87.1)
339

94.6
(84.6, 105.7)

370
125.6

(112.6, 140.2)

Dose 3 362
152.9

(137.2, 170.5)
359

155.6
(140.4, 172.4)

-- --

PMB2948 
(B24)

hSBA GMT

Dose 2 344
13.8

(12.2, 15.6)
337

14.9
(13.2, 16.7)

359
20.6

(18.4, 23.2)

Dose 3 354
29.1

(25.9, 32.7)
354

25.6
(23.0, 28.5)

-- --

PMB2707 
(B44)

hSBA GMT

Dose 2 341
13.1

(11.3, 15.1)
331

15.5
(13.5, 17.9)

356
22.5

(19.6, 25.7)

Dose 3 356
40.3

(35.2, 46.1)
352

35.0
(30.6, 39.9)

-- --

Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement;
fHbp=factor H binding protein.

Study B1971009 was a Phase 3, randomised, active-controlled, observer-blinded, multicentre trial in 
which subjects 10 to 18 years of age received 1 of 3 lots (Groups 1, 2, and 3) of Trumenba or the 



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active control hepatitis A virus (HAV) vaccine/saline. A total of 2,693 subjects received at least 1 dose 
of Trumenba and 897 received at least 1 dose of HAV vaccine/saline. The study assessed the safety, 
tolerability, immunogenicity, and demonstration of manufacturability of 3 lots of Trumenba 
administered on a 0-, 2-, and 6-month schedule. The hSBA responses observed after the third dose in 
Group 1 are presented in Tables 3 and 4. Results from Groups 2 and 3 are not presented, as only 
2 representative strains were evaluated. Similar results were observed in Groups 2 and 3 as observed 
in Group 1. 

Study B1971016 was a Phase 3, randomised, placebo-controlled, observer-blinded, multicentre trial in 
which subjects 18 to 25 years of age were assigned to 2 groups in a 3:1 ratio (Group 1:Group 2). 
Group 1 received Trumenba at months 0, 2, and 6. Group 2 received saline at months 0, 2, and 6. A 
total of 2,471 subjects received Trumenba and 822 received saline. The hSBA responses observed 
after the third dose in Groups 1 and 2 are presented in Tables 3 and 4.

Serum was obtained approximately 1 month after vaccination.

Table 3. Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third 
Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and 
Study B1971016) 

Study B1971009
(10-18 years of age)

Study B1971016
(18-25 years of age)

Group 1 Group 4 Group 1 Group 2

Trumenba HAV/saline Trumenba Saline

hSBA Strain

(fHbp Variant)                 
N

%

(95% CI)
N

%

(95% CI)
N

%

(95% CI)
N

%

(95% CI)

PMB80 

(A22)

% hSBA ≥ 1:16

1266
97.8

(96.8, 98.5)
749

34.0

(30.7, 37.6)
1714

93.5

(92.2, 94.6)
577

36.6

(32.6, 40.6)

≥ 4-Fold rise in hSBA titre (%)

1225
83.2

(81.0, 85.2)
730

9.6

(7.6, 12.0)
1695

80.5

(78.6, 82.4)
568

6.3

(4.5, 8.7)

PMB2001 

(A56)

% hSBA ≥ 1:8

1229
99.5

(98.9, 99.8)
363

27.5

(23.0, 32.5)
1708

99.4

(98.9, 99.7)
552

34.2

(30.3, 38.4)

≥ 4-Fold rise in hSBA titre (%)

1128
90.2 

(88.4, 91.9)
337

11.3

(8.1, 15.1)
1642

90.0

(88.4, 91.4)
533

10.3

(7.9, 13.2)

PMB2948 

(B24)

% hSBA ≥ 1:8

1250
87.1

(85.1, 88.9)
762

7.0

(5.3, 9.0)
1702

95.1

(93.9, 96.0)
573

30.2

(26.5, 34.1)

≥ 4-Fold rise in hSBA titre (%)

1235
79.8

(77.4, 82.0)
752

2.7

(1.6, 4.1)
1675

79.3

(77.3, 81.2)
562

5.5

(3.8, 7.7)

PMB2707 

(B44)

% hSBA ≥ 1:8

1210
89.3

(87.4, 90.9)
393

5.3

(3.3, 8.1)
1703

87.4 

(85.8, 89.0)
577

11.4 

(9.0, 14.3)

≥ 4-Fold rise in hSBA titre (%)

1203
85.9

(83.8, 87.8)
391

1.0

(0.3, 2.6)
1696

79.6

(77.6, 81.5)
573

1.6

(0.7, 3.0)



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Table 3. Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third 
Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and 
Study B1971016) 

Study B1971009
(10-18 years of age)

Study B1971016
(18-25 years of age)

Group 1 Group 4 Group 1 Group 2

Trumenba HAV/saline Trumenba Saline

Composite response (A response for all 4 hSBA strains combined)

Before 

Dose 1
1088

1.1

(0.6, 1.9)
354

2.0

(0.8, 4.0)
1612

7.3

(6.0, 8.6)
541

6.1

(4.2, 8.5)

Dose 3 1170
83.5

(81.3, 85.6)
353

2.8

(1.4, 5.1)
1664

84.9

(83.1, 86.6)
535

7.5

(5.4, 10.0)
Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein; HAV=hepatitis A 
virus vaccine.
Note: The lower limit of quantitation is an hSBA titre=1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 
(B24), and PMB2707 (B44).

Table 4. Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third 
Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and 
B1971016)

Study B1971009
(10-18 years of age)

Study B1971016
(18-25 years of age)

Group 1 Group 4 Group 1 Group 2
Trumenba HAV/saline Trumenba Saline

hSBA Strain 
(fHbp Variant)

N
GMT

(95% CI)
N

GMT
(95% CI)

N
GMT

(95% CI)
N

GMT
(95% CI)

PMB80 (A22) 1266
86.8

(82.3, 91.5)
749

12.6
(12.0, 13.4)

1714
74.3

(70.2, 78.6)
577

13.2
(12.4, 14.1)

PMB2001 
(A56)

1229
222.5

(210.1, 235.6)
363

8.8
(7.6, 10.1)

1708
176.7

(167.8, 186.1)
552

9.1
(8.2, 10.1)

PMB2948 
(B24)

1250
24.1

(22.7, 25.5)
762

4.5
(4.4, 4.7)

1702
49.5

(46.8, 52.4)
573

7.2
(6.6, 7.8)

PMB2707 
(B44)

1210
50.9

(47.0, 55.2)
393

4.4
(4.2, 4.6)

1703
47.6

(44.2, 51.3)
577

4.8
(4.6, 5.1)

Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHbp=factor H 
binding protein; HAV=hepatitis A virus vaccine.

In Studies B1971009 and B1971016, the proportion of subjects achieving a defined hSBA titre after 
3 doses of Trumenba, administered on a 0-, 2-, and 6-month schedule, was evaluated against a panel of 
10 additional strains, each expressing a different fHbp variant (Table 5). These additional hSBAs 
support and extend the breadth of vaccine coverage demonstrated by the 4 representative primary 
strains (Tables 3 and 4). 

Serum was obtained approximately 1 month after vaccination.



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Table 5. Immune Responses Among Individuals 10 to 25 Years of Age Against 10 
Additional Strains 1 Month Following the Third Dose of Trumenba Given on a 0-, 
2-, 6-Month Schedule (Study B1971009 and Study B1971016)

Study B1971009 Study B1971016
(10 to 18 Years of Age) (18 to 25 Years of Age)

N
%

(95% CI)
N

%
(95% CI)

hSBA Strain (fHbp Variant)
                                           Dose
    % hSBA ≥ 1:8

PMB3040 (A07) 280
96.4

(93.5, 98.3)
277

95.7
(92.6, 97.7)

PMB1672 (A15) 266
87.2

(82.6, 91.0)
279

91.8
(87.9, 94.7)

PMB3175 (A29) 278
98.6

(96.4, 99.6)
283

99.3
(97.5, 99.9)

PMB1256 (B03) 279
92.5

(88.7, 95.3)
273

86.4
(81.8, 90.3)

PMB866 (B09) 276
86.2

(81.6, 90.1)
274

77.0
(71.6, 81.9)

PMB431 (B15) 281
98.2

(95.9, 99.4)
276

96.7
(93.9, 98.5)

PMB648 (B16) 278
81.7

(76.6, 86.0)
273

78.0
(72.6, 82.8)

% hSBA ≥ 1:16

PMB3010 (A06) 280
95.7

(92.6, 97.8)
275

92.0
(88.1, 94.9)

PMB824 (A12) 277
75.1

(69.6, 80.1)
275

71.3
(65.5, 76.5)

PMB1989 (A19)
275

92.7
(89.0, 95.5)

284
95.8

(92.7, 97.8)
Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein.

Study B1971033 was an open-label, follow-up study of subjects previously enrolled in a primary 
study, including Study B1971012. Subjects attended visits over 4 years for collection of blood samples 
and received a single booster dose of Trumenba approximately 4 years after receipt of a primary series 
of 2 or 3 doses of Trumenba. The hSBA responses 4 years after the primary series and 26 months after 
the booster dose for subjects enrolled from primary Study B1971012 Group 1 (0-, 1-, 6-Month 
Schedule), Group 2 (0-, 2-, 6-Month), and Group 3 (0-, 6-Month) are presented in Tables 6 and 7. A 
booster response was observed as measured by hSBA at 1 month following a dose of Trumenba 
approximately 4 years after a primary series of 2 doses (Group 3) or 3 doses (Groups 1 and 2).



12

Table 6: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age 
Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 
0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033)

Primary Study B1971012 Vaccine Group (as Randomised)
Group 1 Group 2 Group 3

(0, 1, and 6 Months) (0, 2, and 
6 Months)

(0 and 6 Months)

N
%

(95% CI)
N

%
(95% CI)

N
%

(95% CI)
hSBA Strain (fHbp Variant)
                         
                        Time Point

PMB80 
(A22)

% hSBA ≥ 1:16
1 Month after last 
primary dose

59
89.8

(79.2, 96.2)
57

91.2
(80.7, 97.1)

61
98.4

(91.2, 100.0)
12 Months after 
last primary dose

99
41.4

(31.6, 51.8)
111

45.0
(35.6, 54.8)

113
36.3

(27.4, 45.9)
48 Months after 
last primary dose

59
49.2

(35.9, 62.5)
57

56.1
(42.4, 69.3)

61
55.7

(42.4, 68.5)
1 Month after 
booster dose

59
100.0

(93.9, 100.0)
58

100.0
(93.8, 100.0)

60
96.7

(88.5, 99.6)
12 Months after 
booster dose

58
74.1

(61.0, 84.7)
54

77.8
(64.4, 88.0)

60
80.0

(67.7, 89.2)
26 Months after 
booster dose

0 NE 34
73.5

(55.6, 87.1)
42

61.9
(45.6, 76.4)

PMB2001 
(A56)

% hSBA ≥ 1:8
1 Month after last 
primary dose

58
100.0

(93.8, 100.0)
57

98.2
(90.6, 100.0)

62
98.4

(91.3, 100.0)
12 Months after 
last primary dose

98
73.5

(63.6, 81.9)
109

76.1
(67.0, 83.8)

106
60.4

(50.4, 69.7)
48 Months after 
last primary dose

53
43.4

(29.8, 57.7)
55

56.4
(42.3, 69.7)

62
43.5

(31.0, 56.7)
1 Month after 
booster dose

57
100.0

(93.7, 100.0)
56

100.0
(93.6, 100.0)

62
98.4

(91.3, 100.0)
12 Months after 
booster dose

55
90.9

(80.0, 97.0)
55

89.1
(77.8, 95.9)

59
81.4

(69.1, 90.3)
26 Months after 
booster dose

0 NE 29
82.8

(64.2, 94.2)
40

57.5
(40.9, 73.0)

PMB2948 
(B24)

% hSBA ≥ 1:8
1 Month after last 
primary dose

59
88.1

(77.1, 95.1)
58

91.4
(81.0, 97.1)

60
85.0

(73.4, 92.9)
12 Months after 
last primary dose

98
40.8

(31.0, 51.2)
108

49.1
(39.3, 58.9)

103
36.9

(27.6, 47.0)
48 Months after 
last primary dose

59
40.7

(28.1, 54.3)
57

49.1
(35.6, 62.7)

62
40.3

(28.1, 53.6)
1 Month after 
booster dose

58
100.0

(93.8, 100.0)
57

100.0
(93.7, 100.0)

62
96.8

(88.8, 99.6)
12 Months after 
booster dose

58
65.5

(51.9, 77.5)
54

74.1
(60.3, 85.0)

62
77.4

(65.0, 87.1)
26 Months after 
booster dose

0 NE 33 
78.8

(61.1, 91.0)
42

59.5
(43.3, 74.4)



13

Table 6: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age 
Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 
0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033)

Primary Study B1971012 Vaccine Group (as Randomised)
Group 1 Group 2 Group 3

(0, 1, and 6 Months) (0, 2, and 
6 Months)

(0 and 6 Months)

N
%

(95% CI)
N

%
(95% CI)

N
%

(95% CI)

PMB2707 
(B44)

% hSBA ≥ 1:8
1 Month after last 
primary dose

58
86.2

(74.6, 93.9)
57

89.5
(78.5, 96.0)

60 81.7
(69.6, 90.5)

12 Months after 
last primary dose

100
24.0

(16.0, 33.6)
111

22.5
(15.1, 31.4)

115
16.5

(10.3, 24.6)
48 Months after 
last primary dose

57
36.8

(24.4, 50.7)
57

35.1
(22.9, 48.9)

62
12.9

(5.7, 23.9)
1 Month after 
booster dose

59
100.0

(93.9, 100.0)
58

100.0
(93.8, 100.0)

61
93.4

(84.1, 98.2)
12 Months after 
booster dose

56
75.0

(61.6, 85.6)
53

81.1
(68.0, 90.6)

61
59.0

(45.7, 71.4)
26 Months after 
booster dose

0 NE 33
66.7

(48.2, 82.0)
43

62.8
(46.7, 77.0)

Composite response (A response for all 4 hSBA strains combined)
1 Month after last 
primary dose

57
80.7

(68.1, 90.0)
55

87.3
(75.5, 94.7)

57
77.2

(64.2, 87.3)
12 Months after 
last primary dose

55
10.9

(4.1, 22.2)
51

13.7
(5.7, 26.3)

49
20.4

(10.2, 34.3)
48 Months after 
last primary dose

51
19.6

(9.8, 33.1)
53

30.2
(18.3, 44.3)

61
9.8

(3.7, 20.2)
1 Month after 
booster dose

56
100

(93.6, 100.0)
55

100.0
(93.5, 100.0)

59
91.5

(81.3, 97.2)
12 Months after 
booster dose

53
52.8

(38.6, 66.7)
48

64.6
(49.5, 77.8)

57
61.4

(47.6, 74.0)
26 Months after 
booster dose

0 NE 27
48.1

(28.7, 68.1)
36

44.4
(27.9, 61.9)

Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein; NE=not evaluated 
(subjects were not followed beyond 12 months post booster).
Note: The lower limit of quantitation is an hSBA titre=1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), 
and PMB2707 (B44).
Serum samples were analyzed concurrently in the same serology campaign for all time points except the 12 months post-primary 
dose time point for which results are from the interim analysis.



14

Table 7: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age 
Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 
0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033)

Primary Study B1971012 Vaccine Group (as Randomised)
Group 1 Group 2 Group 3

(0, 1, and 6 
Months)

(0, 2, and 6 
Months)

(0 and 6 Months)

N
GMT

(95% CI)
N

GMT
(95% CI)

N
GMT

(95% CI)
hSBA Strain (fHbp Variant)
                         
                        Time Point

PMB80 
(A22)

hSBA GMT
1 Month after last 
primary dose

59
53.0

(40.4, 69.6)
57

59.5
(45.5, 77.8)

61
55.8

(46.2, 67.4)
12 Months after 
last primary dose

99
14.9

(12.6, 17.7)
111

15.8
(13.4, 18.6)

113
15.6

(13.0, 18.8)
48 Months after 
last primary dose

59
16.6

(13.0, 21.1)
57

20.7
(15.6, 27.4)

61
16.6

(13.4, 20.5)
1 Month after 
booster dose 59

126.5
(102.7, 155.8)

58
176.7

(137.8, 
226.7)

60
142.0

(102.9, 196.1)

12 Months after 
booster dose

58
33.6

(24.5, 46.1)
54

44.1
(31.2, 62.4)

60
31.6

(23.5, 42.5)
26 Months after 
booster dose

0 NE 34
34.7

(23.0, 52.4)
42

27.1
(18.6, 39.6)

PMB2001 
(A56)

hSBA GMT
1 Month after last 
primary dose 58

158.7
(121.5, 207.3)

57
191.2

(145.8, 
250.8)

62
143.1

(109.6, 187.0)

12 Months after 
last primary dose

98
25.7

(19.4, 34.0)
109

27.3
(21.0, 35.4)

106
18.5

(13.8, 24.7)
48 Months after 
last primary dose

53
10.7

(7.4, 15.3)
55

15.0
(10.2, 22.2)

62
10.8

(7.6, 15.3)
1 Month after 
booster dose 57

359.8
(278.7, 464.7)

56
414.8

(298.8, 
575.9)

62
313.1

(221.3, 442.8)

12 Months after 
booster dose

55
47.3

(34.3, 65.3)
55

64.0
(42.6, 96.2)

59
41.0

(26.7, 62.7)
26 Months after 
booster dose

0 NE 29
37.8

(21.3, 67.2)
40

16.0
(9.9, 25.8)

PMB2948 
(B24)

hSBA GMT
1 Month after last 
primary dose

59
25.6

(19.7, 33.3)
58

30.5
(23.8, 39.1)

60
29.2

(21.5, 39.6)
12 Months after 
last primary dose

98
9.7

(7.5, 12.4)
108

11.5
(9.0, 14.6)

103
8.4

(6.7, 10.6)
48 Months after 
last primary dose

59
10.7

(7.6, 15.1)
57

11.4
(8.2, 15.9)

62
8.9

(6.8, 11.8)
1 Month after 
booster dose

58
94.9

(74.6, 120.9)
57

101.6
(83.1, 124.2)

62
79.1

(60.6, 103.5)
12 Months after 
booster dose

58
21.1

(14.2, 31.3)
54

25.7
(17.7, 37.5)

62
22.4

(16.4, 30.5)
26 Months after 
booster dose

0 NE 33
24.4

(16.1, 36.8)
42

14.5
(9.9, 21.3)



15

Table 7: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age 
Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 
0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033)

Primary Study B1971012 Vaccine Group (as Randomised)
Group 1 Group 2 Group 3

(0, 1, and 6 
Months)

(0, 2, and 6 
Months)

(0 and 6 Months)

N
GMT

(95% CI)
N

GMT
(95% CI)

N
GMT

(95% CI)

PMB2707 
(B44)

hSBA GMT
1 Month after last 
primary dose

58
46.3

(31.7, 67.8)
57

50.2
(35.3, 71.3)

60
35.5

(24.5, 51.4)
12 Months after 
last primary dose

10
0

6.4
(5.2, 7.8)

111
6.0

(5.1, 7.2)
115

5.6
(4.8, 6.5)

48 Months after 
last primary dose

57
8.3

(6.3, 11.0)
57

7.6
(5.8, 10.0)

62
4.6

(4.1, 5.1)
1 Month after 
booster dose 59

137.3
(100.3, 188.0)

58
135.9

(108.0, 
171.0)

61
74.2

(51.6, 106.8)

12 Months after 
booster dose

56
23.2

(16.2, 33.2)
53

24.3
(17.8, 33.3)

61
13.3

(9.7, 18.3)
26 Months after 
booster dose

0 NE 33
16.0

(10.4, 24.7)
43

13.6
(9.8, 18.9)

Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHbp=factor H binding 

protein; NE=not evaluated (subjects were not followed beyond 12 months post booster).
Note: Serum samples were analyzed concurrently in the same serology campaign for all time points except the 12 months 
post-primary dose time point for which results are from the interim analysis.

Immunogenicity in individuals 1 to 9 years of age

The immunogenicity of Trumenba (0-, 2-, 6-month schedule) in toddlers and children 1 to 9 years of 
age was evaluated in 2 Phase 2 studies. At 1 month following series completion, 81.4% to 100% of 
subjects achieved a response to the 4 primary meningococcal test strains (defined as hSBA ≥ 1:16 for 
A22; ≥ 1:8 for A56, B24 and B44) compared to 0.4% to 6.5% at baseline. 

There are no persistence data in children 1 to < 2 years of age. In children 2 to 9 years of age, 
6 months following series completion, 32.5%, 82.4%, 15.5% and 10.4% of participants maintained a 
response to the primary test strains A22, A56, B24 and B44, respectively. See section 4.2 for
information on use in children 1 to 9 years of age.

The European Medicines Agency has deferred the obligation to submit the results of studies with 
Trumenba in one or more subsets of the paediatric population for prevention of invasive 
meningococcal disease caused by N. meningitidis serogroup B (see section 4.2 for information on 
paediatric use).

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of repeated 
dose toxicity and reproduction and developmental toxicity.



16

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Chloride
Histidine
Polysorbate 80 (E433)
Water for injections
For adsorbent, see section 2.

6.2 Incompatibilities

Do not mix Trumenba with other vaccines or medicinal products in the same syringe. 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products.

6.3 Shelf life

4 years.

6.4 Special precautions for storage

Store in a refrigerator (2 °C-8 °C).
Syringes should be stored in the refrigerator horizontally to minimize the re-dispersion time.
Do not freeze. 

6.5 Nature and contents of container

0.5 ml suspension in a pre-filled syringe (Type I glass) with plastic Luer Lok adapter, chlorobutyl 
rubber plunger stopper, and a synthetic isoprene bromobutyl rubber tip cap with a plastic rigid tip cap 
cover with or without needle. The tip cap and rubber plunger of the pre-filled syringe are not made 
with natural rubber latex.

Pack sizes of 1, 5, and 10 pre-filled syringes, with or without needle. 

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe 
containing the suspension.

Before use, the pre-filled syringe should be shaken vigorously to ensure that a homogeneous white 
suspension is obtained.

Do not use the vaccine if it cannot be re-suspended. 

The vaccine should be visually inspected for particulate matter and discoloration prior to 
administration. In the event of any foreign particulate matter and/or variation of physical aspect being 
observed, do not administer the vaccine.

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.



17

7 MARKETING AUTHORISATION HOLDER

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

8. MARKETING AUTHORISATION NUMBER(S) 

EU/1/17/1187/001
EU/1/17/1187/002
EU/1/17/1187/003
EU/1/17/1187/004
EU/1/17/1187/005
EU/1/17/1187/006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24th May 2017 

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

http://www.ema.europa.eu/


18

ANNEX II

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT



19

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE 
AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers of the biological active substance

Boehringer Ingelheim RCV GmbH & Co KG (BI RCV)
Dr. Boehringer Gasse 5-11
A-1121 Vienna
Austria

Or

Pfizer Health AB
Mariefredsvägen 37
S-645 41 Strängnäs
Sweden

Name and address of the manufacturer responsible for batch release

Pfizer Manufacturing Belgium N.V.
Rijksweg 12
B-2870 Puurs
Belgium

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to medical prescription.

 Official batch release

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken 
by a state laboratory or a laboratory designated for that purpose.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP.



20

An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached.



21

ANNEX III

LABELLING AND PACKAGE LEAFLET



22

A. LABELLING



23

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer Carton Pack of 1, 5 or 10 pre-filled syringes; with or without needles

1. NAME OF THE MEDICINAL PRODUCT

Trumenba suspension for injection in pre-filled syringe 
meningococcal group B vaccine (recombinant, adsorbed) 

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

Neisseria meningitidis serogroup B fHbp subfamily A and B 60 micrograms each

3. LIST OF EXCIPIENTS

Sodium chloride, histidine, water for injections, aluminium phosphate and polysorbate 80 (E433).

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection
1 single-dose (0.5 ml) pre-filled syringe with needle 
1 single-dose (0.5 ml) pre-filled syringe without needle 
5 single-dose (0.5 ml) pre-filled syringes with needles 
5 single-dose (0.5 ml) pre-filled syringes without needles 
10 single-dose (0.5 ml) pre-filled syringes with needles 
10 single-dose (0.5 ml) pre-filled syringes without needles

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use. 
Shake well before use. 
Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY



24

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator.
Syringes should be stored in the refrigerator horizontally to minimize the re-dispersion time.
Do not freeze. 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/17/1187/001 – pack of 1 with separate needle
EU/1/17/1187/002 – pack of 1 without needle
EU/1/17/1187/003 – pack of 5 with separate needles
EU/1/17/1187/004 – pack of 5 without needles
EU/1/17/1187/005 – pack of 10 with separate needles
EU/1/17/1187/006 – pack of 10 without needles

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE



25

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



26

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Pre-filled syringe label

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Trumenba suspension for injection
meningococcal B vaccine 
IM

2. METHOD OF ADMINISTRATION

Shake well before use.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 dose (0.5 ml)

6. OTHER



27

B. PACKAGE LEAFLET



28

Package leaflet: Information for the user

Trumenba suspension for injection in pre-filled syringe
meningococcal group B vaccine

(recombinant, adsorbed) 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you or your child receives this vaccine because it contains 
important information for you or your child

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This vaccine has been prescribed for you or your child only.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Trumenba is and what it is used for 
2. What you need to know before you or your child receives Trumenba
3. How Trumenba is given 
4. Possible side effects 
5. How to store Trumenba 
6. Contents of the pack and other information

1. What Trumenba is and what it is used for

Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidis 
serogroup B, for use in people 10 years and older. This is a type of bacteria that can cause serious and 
sometimes life threatening infections such as meningitis (inflammation of the covering of the brain 
and spinal cord) and sepsis (blood poisoning).

The vaccine contains 2 important components from the surface of the bacteria. 

The vaccine works by helping the body to make antibodies (the body’s natural defences) which protect 
you or your child against this disease. 

2. What you need to know before you or your child receives Trumenba

Trumenba should not be given
- if you or your child are allergic to the active substance or any of the other ingredients of this 

medicine (listed in section 6). 

Warnings and precautions 
Talk to your doctor, pharmacist or nurse before vaccination with Trumenba. Tell your doctor, 
pharmacist or nurse if you or your child:
 have a severe infection with a high fever. If this is the case, then vaccination will be postponed. The 

presence of a minor infection, such as a cold, should not require postponement of the vaccination, 
but talk to your doctor first.

 have a bleeding problem or bruise easily. 



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 have a weakened immune system which may prevent you or your child from getting the full 
benefit from Trumenba.

 have had any problems after any dose of Trumenba such as an allergic reaction or problems with 
breathing.

Fainting, feeling faint, or other stress-related reactions can occur as a response to any needle injection. 
Tell your doctor, pharmacist or nurse if you have experienced this kind of reaction previously. 

Other medicines and Trumenba
Tell your doctor, pharmacist or nurse if you or your child are using, have recently used or might use 
any other medicines or have recently received any other vaccine. 

Trumenba can be given at the same time as any of the following vaccine components: tetanus,
diphtheria, whooping cough (pertussis), poliovirus, papillomavirus, and meningococcal serogroups A, 
C, W, Y.

Administration of Trumenba with vaccines other than those mentioned above, has not been studied.

If you receive more than 1 vaccination at the same time it is important that different injection sites are 
used.

If you take medicines that affect your immune system (such as radiation therapy, corticosteroids, or 
some types of cancer chemotherapies), you may not get the full benefit of Trumenba.

Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before Trumenba is given. Your doctor may still recommend that you receive 
Trumenba if you are at risk of meningococcal disease.

Driving and using machines 
Trumenba has no or little influence on the ability to drive and use machines. 

However, some of the side effects mentioned under section 4 ‘Possible side effects’ may temporarily 
affect you. If this occurs, wait until the effects wear off before driving or using machines.

Trumenba contains sodium
This medicinal product contains less than 23 mg sodium per dose, i.e. essentially ‘sodium-free’.

3. How Trumenba is given

Trumenba will be given to you or your child by a doctor, pharmacist or nurse. It will be injected into 
the upper arm muscle. 

It is important to follow the instructions from the doctor, pharmacist or nurse so that you or your child 
completes the course of injections. 

Individuals 10 years and older
- You or your child will receive 2 injections of the vaccine, the second injection is given 6 

months after the first injection.
- You or your child will receive 2 injections of the vaccine given at least 1 month apart and a 

third injection at least 4 months after the second injection. 
- You or your child may be given a booster.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.



30

When Trumenba is given to your or your child, the following side effects may occur:

Very common (may affect more than 1 in 10 people)
- Redness, swelling and pain at injection site
- Headache
- Diarrhoea
- Nausea
- Muscle pain
- Joint pain
- Chills
- Fatigue

Common (may affect up to 1 in 10 people) 
- Vomiting
- Fever ≥38 °C 

Not known (frequency cannot be estimated from the available data) 
- Allergic reactions 

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.

5. How to store Trumenba

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month.

Store in a refrigerator (2 °C-8 °C).

Syringes should be stored in the refrigerator horizontally to minimize the re-dispersion time.

Do not freeze. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Trumenba contains 

One dose (0.5 ml) contains:

Active substances:

Neisseria meningitidis serogroup B fHbp subfamily A1,2,3 60 micrograms
Neisseria meningitidis serogroup B fHbp subfamily B1,2,3 60 micrograms

1 Recombinant lipidated fHbp (factor H binding protein)

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


31

2 Produced in Escherichia coli cells by recombinant DNA technology
3 Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose) 

Other ingredients:

Sodium chloride, histidine, water for injections, and polysorbate 80 (E433).

What Trumenba looks like and contents of the pack

Trumenba is a white suspension for injection, provided in a pre-filled syringe. 

Pack sizes of 1, 5, and 10 pre-filled syringes with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer responsible for batch release:
Pfizer Manufacturing Belgium N.V.
Rijksweg 12
B-2870 Puurs
Belgium

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien 
Luxembourg/Luxemburg
Pfizer S.A./N.V.
Tél/Tel: + 32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

България
Пфайзер Люксембург САРЛ, Клон
България
Teл.: +359 2 970 4333

Magyarország
Pfizer Kft
Tel: +36 1 488 3700

Česká republika
Pfizer PFE, spol. s r.o.
Tel: + 420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: + 35621 344610

Danmark
Pfizer ApS
Tlf: + 45 44 201 100

Nederland
Pfizer BV
Tel: +31 (0)10 406 43 01

Deutschland
Pfizer Pharma GmbH
Tel: + 49 (0)30 550055-51000

Norge
Pfizer Norge AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel.: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H
Tel: + 43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00



32

España
Pfizer, S.L.
Tel+34914909900

Portugal
Pfizer Biofarmacêutica, Sociedade Unipessoal
Lda.
Tel: (+351) 21 423 55 00

France
Pfizer
Tél +33 1 58 07 34 40

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

Slovenija
Pfizer Luxembourg SARL Pfizer, podružnica za 
svetovanje s področja farmacevtske dejavnosti, 
Ljubljana
Tel.: + 386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL,
organizačná zložka
Tel: + 421 2 3355 5500

Ísland
Icepharma hf
Simi: + 354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer s.r.1
Tel: +39 06 33 18 21

Sverige
Pfizer Innovations AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Tηλ: +357 22 817690

United Kingdom
Pfizer Limited
Tel: +44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: + 371 670 35 775

This leaflet was last revised in 

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

During storage, a white deposit and clear supernatant may be observed.

The vaccine should be visually inspected for particulate matter and discoloration prior to 
administration. In the event of any foreign particulate matter and/or variation of physical aspect being 
observed, do not administer the vaccine.

Shake well prior to use to obtain a homogeneous white suspension.

http://www.ema.europa.eu/


33

Trumenba is for intramuscular use only. Do not administer intravascularly or subcutaneously. 

Trumenba must not be mixed with any other vaccines in the same syringe. 

When given at the same time with other vaccines Trumenba must be given at separate injection sites.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCEAND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET