TRUMENBA (Meningococcal group B vaccine)

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Health Professional Information

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Warnings And Precautions

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General

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare 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.

Do not inject intravenously, intradermally, or subcutaneously.

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

Hematologic

As with any intramuscular vaccine, Trumenba should be given with caution to individuals with thrombocytopenia or any coagulation disorder or to those receiving anticoagulant therapy, unless the potential benefit clearly outweighs the risk of administration.

Immune

There are no data available for immunocompromised individuals, including those receiving immunosuppressant therapy.

Individuals with certain complement deficiencies and individuals receiving treatment that inhibits 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.

Sexual Function/Reproduction

There are no data on fertility in humans.

Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see TOXICOLOGY). Trumenba has not been evaluated for impairment of fertility in males.

Special Populations

Pregnant Women:

There are no data from the use of Trumenba in pregnant women.

Reproduction studies performed in female rabbits at doses equivalent to the highest administered human dose have revealed no evidence of impaired female fertility or harm to the fetus due to Trumenba. Because animal reproductive studies are not always predictive of the human response, Trumenba should be used during pregnancy only if the potential benefits clearly outweigh the potential risks.

Nursing Women:

It is unknown whether Trumenba is excreted in human milk.

Trumenba should only be used during breast-feeding when the potential benefits outweigh the potential risks.

Pediatrics (< 10 years of age):

Safety and efficacy of Trumenba in children below the age of 10 years of age have not been established.

Geriatrics (> 65 years of age):

Trumenba has not been studied in adults older than 65 years of age.

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Adverse Reactions

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Adverse Drug Reaction Overview

In clinical studies, the most common solicited adverse reactions were pain at the injection site, fatigue, headache, and muscle pain (see Tables 1 and 2). Nausea was reported in up to 22% of subjects in early phase studies. Most local and systemic reactions were mild or moderate in severity and resolved within 1 to 3 days after vaccination. The frequencies of solicited adverse reactions were highest after the first dose regardless of the schedule. The frequencies of solicited adverse reactions after subsequent doses were similar.

Overall, data for adverse events (AEs) summarized by age, sex, and race were comparable to AEs reported for the overall population.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

The safety of Trumenba was investigated in 11 completed clinical studies (see CLINICAL TRIALS, Table 3) that enrolled a total of 20,803 subjects, of which 15,294 subjects received at least 1 dose of Trumenba (any dose level or vaccination regimen) administered alone or concomitantly with a licensed vaccine and 5509 control subjects received either saline alone, a licensed vaccine alone, or saline and a licensed vaccine. The core safety dataset comprises data derived from the 8 controlled studies for subjects who received at least 1 dose of Trumenba 120 mcg administered alone or concomitantly with a licensed vaccine on a schedule of 0, 2, and 6 months (n=13,284) or control vaccine (n=5509).

The safety evaluation in the clinical studies included an assessment of: (1) solicited local and systemic reactions, and use of antipyretic medication after each vaccination in an electronic diary maintained by the subject or the subject’s parent/legal guardian; and (2) spontaneous reports of adverse events (AEs), including serious adverse events (SAEs) throughout the study (day of vaccination through 1 month or 6 months after the last vaccination, depending on the study and safety parameter).

Solicited Local and Systemic Reactions
Tables 1 and 2 present the percentage of subjects who reported solicited local (Table 1) and systemic (Table 2) reactions, regardless of causality, within 7 days of each dose of Trumenba or control (hepatitis A virus vaccine [HAV]/saline or saline) for pivotal Phase 3 studies 1009 and 1016, which both included Canadian patients.

Study 1009 was a Phase 3, randomized, active-controlled, observer-blinded, global, multicenter trial in which 2,693 subjects 10 to 18 years of age received at least 1 dose of Trumenba on a 0-, 2-, and 6- month schedule. A control group received HAV at 0 and 6 months and received saline at 2 months. Subjects were randomized to receive 1 of 3 lots of Trumenba or HAV/saline.

Study 1016 was a Phase 3, randomized, placebo-controlled, observer-blinded, global, multicenter trial in which 2,471 subjects 18 to 25 years of age received at least 1 dose of Trumenba or saline on a 0-, 2,- and 6- month schedule.

Table 1: Percentage of Subjects 10 to 18 Years of Age (Study 1009) and 18 to 25 Years of Age (Study 1016) Reporting Solicited Local Reactions Within 7 Days After Each Vaccination
a Trumenba, hepatitis A virus vaccine (HAV)/saline, and saline were administered at 0, 2, and 6 months. b Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity) c "Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination. d Mild (2.5-5.0 cm); Moderate (5.5-10.0 cm); Severe (>10.0 cm).
Local Reaction	Study 1009						Study 1016
	Trumenba^a			HAV/Saline^a			Trumenba^a			Saline^a
	Dose 1	Dose 2	Dose 3	Dose 1	Dose 2	Dose 3	Dose 1	Dose 2	Dose 3	Dose 1	Dose 2	Dose 3
	N=2681	N=2545	N=2421	N=890	N=843	N=821	N=2425	N=2076	N=1823	N=798	N=706	N=624
Pain^b
Any^c	86.7	77.7	76.0	47.0	15.2	34.0	84.2	79.3	80.4	11.8	7.8	6.7
Mild	41.1	39.4	34.1	36.5	12.3	23.8	42.3	42.2	36.1	10.7	6.8	6.4
Moderate	40.7	33.2	36.5	9.9	2.7	9.9	37.1	32.7	38.9	1.1	1.0	0.3
Severe	5.0	5.1	5.4	0.6	0.1	0.4	4.8	4.4	5.3	0.0	0.0	0.0
Redness^d
Any^c	16.2	12.5	13.9	1.3	0.6	1.1	13.8	11.8	17.1	0.6	0.3	0.2
Mild	5.6	5.2	4.9	1.2	0.6	1.0	5.8	4.6	6.2	0.5	0.1	0.2
Moderate	8.8	6.1	6.8	0.1	0.0	0.1	7.1	6.3	8.6	0.0	0.0	0.0
Severe	1.9	1.1	2.2	0.0	0.0	0.0	0.9	0.9	2.3	0.1	0.1	0.0
Swelling^d
Any^c	18.0	13.9	15.4	2.2	0.6	0.9	15.5	14.0	16.6	0.6	0.4	0.3
Mild	8.5	6.3	7.9	1.8	0.5	0.7	8.5	7.7	8.8	0.3	0.3	0.0
Moderate	8.8	7.3	6.8	0.4	0.1	0.1	6.8	6.0	7.2	0.3	0.1	0.3
Severe	0.7	0.2	0.7	0.0	0.0	0.0	0.2	0.3	0.5	0.1	0.0	0.0

Table 2: Percentage of Subjects 10 to 18 Years of Age (Study 1009) and 18 to 25 Years of Age (Study 1016) Reporting Solicited Systemic Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination
a Trumenba, hepatitis A virus vaccine (HAV)/saline, and saline were administered at 0, 2, and 6 months. b Study 1009: Fever (≥38°C): N=2679, 2540, and 2414 for Trumenba at Dose 1, Dose 2, and Dose 3, respectively; N=890, 840, and 819 for HAV/saline at Dose 1, Dose 2, and Dose 3, respectively. c Study 1016: Fever (≥38°C): N=2415, 2067, and 1814 for Trumenba at Dose 1, Dose 2, and Dose 3, respectively; N=796, 705, and 621 for saline at Dose 1, Dose 2, and Dose 3, respectively. d Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (requires intravenous hydration). e "Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination. f Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools in 24 hours); Severe (6 or more loose stools in 24 hours). g Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).
Systemic Reaction	Study 1009						Study 1016
	Trumenba^a			HAV/Saline^a			Trumenba^a			Saline^a
	Dose 1	Dose 2	Dose 3	Dose 1	Dose 2	Dose 3	Dose 1	Dose 2	Dose 3	Dose 1		Dose 2	Dose 3
	N=2681	N=2545	N=2421	N=890	N=843	N=821	N=2425	N=2076	N=1823	N=798		N=706	N=624
Fever (≥38°C)^b,c
≥38.0°C	6.4	2.0	2.7	1.9	1.5	2.3	2.4	1.2	2.0	0.6		1.0	0.6
38.0° to 38.5°C	4.0	1.2	1.8	1.3	0.7	1.3	1.6	0.7	1.4	0.4		0.6	0.5
38.5° to 39.0°C	1.9	0.7	0.6	0.3	0.7	0.4	0.7	0.4	0.4	0.0		0.3	0.2
39.0° to ≤40.0°C	0.5	0.1	0.3	0.2	0.1	0.5	0.0	0.1	0.1	0.3		0.1	0.0
>40.0°C	0.0	0.0	0.0	0.0	0.0	0.1	0.0	0.0	0.1	0.0		0.0	0.0
Vomiting^d
Any^e	3.7	2.2	1.7	1.9	1.4	2.2	2.6	2.1	2.0	2.1		1.6	1.4
Mild	2.8	1.7	1.4	1.7	1.1	1.7	2.2	1.6	1.8	2.1		1.3	1.1
Moderate	0.9	0.4	0.3	0.2	0.4	0.5	0.4	0.5	0.2	0.0		0.3	0.3
Severe	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0		0.0	0.0
Diarrhea^f
Any^e	10.6	7.6	7.7	12.1	9.1	7.6	12.7	8.6	7.5	11.8		8.1	6.9
Mild	9.1	6.2	6.4	10.9	7.6	6.2	10.2	6.4	6.1	9.8		4.7	5.3
Moderate	0.3	1.3	1.0	1.1	1.2	1.1	2.4	1.7	1.2	1.9		2.8	1.3
Severe	0.3	0.1	0.3	0.1	0.4	0.2	0.2	0.5	0.2	0.1		0.6	0.3
Headache^g
Any^e	51.8	37.8	35.4	37.2	28.1	24.8	43.9	33.1	32.5	36.2	24.9		21.6
Mild	28.7	20.2	18.9	24.0	15.7	13.5	24.3	18.4	17.6	22.1	13.6		12.5
Moderate	21.0	16.0	15.2	12.5	10.9	10.4	17.9	13.3	13.3	13.5	10.1		8.3
Severe	2.2	1.7	1.3	0.7	1.5	1.0	1.6	1.4	1.6	0.6	1.3		0.8
Fatigue^g
Any^e	54.0	38.3	35.9	40.3	26.3	24.4	50.9	39.2	39.3	39.8	27.3		24.5
Mild	27.8	20.6	18.4	23.5	13.2	13.5	25.4	20.6	18.9	23.2	13.9		13.1
Moderate	23.2	15.8	15.2	15.2	11.7	10.0	22.1	16.4	18.8	15.8	11.5		9.6
Severe	3.0	1.9	2.3	1.7	1.4	0.9	3.4	2.2	1.6	0.9	2.0		1.8
Chills^g
Any^e	25.3	16.0	13.1	17.2	10.3	8.3	18.1	12.4	12.6	9.8	8.5		6.4
Mild	16.2	10.6	8.7	13.3	8.1	6.5	12.0	8.1	7.7	8.1	6.9		4.3
Moderate	8.0	4.8	3.8	3.5	1.8	1.7	4.9	3.5	4.2	1.6	1.6		2.1
Severe	1.2	0.6	0.5	0.4	0.5	0.1	1.1	0.8	0.8	0.0	0.0		0.0
Muscle pain^g (other than muscle pain at injection site)
Any^e	24.4	17.8	17.6	19.2	10.3	11.1	25.9	15.6	16.9	14.5	8.5		7.5
Mild	13.2	8.7	9.5	13.5	5.2	6.6	13.0	7.6	8.9	9.6	5.8		4.5
Moderate	10.1	7.9	7.2	5.4	4.5	4.3	11.3	7.1	6.8	4.4	2.3		2.9
Severe	1.2	1.2	0.8	0.3	0.6	0.2	1.6	0.8	1.2	0.5	0.4		0.2
Joint pain^g
Any^e	21.9	16.7	16.0	13.6	9.1	8.9	19.6	15.1	12.6	10.9	6.5		5.3
Mild	11.8	8.4	8.9	8.3	5.0	5.5	10.3	8.1	6.6	6.9	3.7		2.9
Moderate	8.7	7.5	5.9	4.6	3.4	3.0	7.9	6.2	5.4	3.5	2.5		2.4
Severe	1.4	0.8	1.2	0.7	0.7	0.4	1.4	0.9	0.6	0.5	0.3		0.0
Use of antipyretic medication	20.7	13.6	12.7	10.4	8.9	6.8	13.4	12.3	12.8	8.9	7.6		6.6

Study 1042¹ was a Phase 2 safety and immunogenicity study in US microbiology laboratory workers (n = 13, 24 to 62 years of age; 8 subjects >40 years of age) who received Trumenba 120 mcg on a 0, 2, 6-month schedule. No new safety signal was identified with the limited number of subjects.

Adverse Events
Overall, in the 8 controlled studies (as described above) adverse events within 30 days after any dose were reported in 30.95% of subjects receiving Trumenba (n=13,284) and 28.37% of subjects in the control group (n=5509). Adverse events that occurred at a frequency of at least 2% and were more frequently observed in subjects who received Trumenba than subjects in the control group were injection site pain (6.84% vs 3.59%), headache (3.78% vs 3.47%), and fever (2.61% vs 1.43%).

Serious Adverse Events
In the 8 controlled studies, serious adverse events (SAEs) were reported by 1.6% and 1.9% of subjects who received at least one dose of Trumenba or control, respectively.

Post-Market Adverse Reactions

The following are considered adverse reactions for Trumenba and were reported in the post-marketing experience. Because these reactions were derived from spontaneous reports, the frequency could not be determined.

Immune system disorders: Allergic reactions

Nervous system disorders: Syncope (fainting)

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Drug Interactions

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Dosage And Administration

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Overdosage

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Action And Clinical Pharmacology

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Mechanism of Action

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 a serum bactericidal assay using human complement (hSBA). A positive response in the hSBA is the only accepted correlate of protection from meningococcal disease.²

Factor H binding protein (fHBP) is a meningococcal surface-exposed antigen expressed by >95% of serogroup B strains. Factor H is a soluble glycoprotein found in human blood which regulates the alternative complement pathway and prevents the damage of human cells by complement.³ Meningococcal fHBP binds human factor H to prevent complement activation, allowing bacteria to avoid host immune defenses.^4,5 Meningococcal fHBP variants segregate into two immunologically distinct subfamilies (designated A and B).

Trumenba is a bivalent vaccine composed of two recombinant lipidated factor H binding proteins – one each from subfamilies A and B. The lipidated protein (which is the naturally occurring form of fHBP) induces antibodies that can kill MnB strains expressing fHBPs that are heterologous to those in the vaccine, whereas non-lipidated variants are unable to induce broadly cross-reactive bactericidal responses. Each Trumenba fHBP antigen elicits cross-protective responses against serogroup B strains expressing diverse fHBP variants from the same subfamily.³ Trumenba prevents serogroup B disease by inducing broadly protective bactericidal antibody responses against diverse fHBP variants expressed by serogroup B strains. ^3,6 Bactericidal antibodies elicited by Trumenba may also prevent factor H from binding to fHBP and render the bacteria more susceptible to complement-mediated killing.⁵

Epidemiology

Invasive meningococcal disease is caused by the Gram negative bacterium Neisseria meningitidis. Out of 12 known serogroups of N. meningitidis, serogroups B, C, W, and Y are most commonly reported in Canada.⁷ While healthy individuals (particularly adolescents and young adults) can carry N. meningitidis asymptomatically, invasive meningococcal disease (IMD) can progress rapidly. Invasive disease typically presents as meningitis and/or septicemia, and can have substantial consequences, with case fatality rates ranging from 5.3% to 10.7%. Approximately 19% of survivors suffer long-term sequelae.^8,9,10

Prior to 2001, serogroup C disease was most prevalent in Canada, representing approximately 40% of IMD cases. Following the introduction of routine serogroup C conjugate immunization programs starting between 2001 and 2005 in all provinces, a significant decline of serogroup C disease was noted, leaving serogroup B as the predominant disease-causing serogroup in Canada. In recent years (2006-2011), serogroup B has caused 50%-62% of all IMD cases, resulting in an incidence rate of 0.33 cases per 100,000 population.^7,10 A prolonged epidemic of serogroup B meningococcal disease has been observed in the province of Quebec.¹¹

When examining the age distribution of cases of serogroup B IMD reported by the Canadian Notifiable Disease Surveillance System (CNDSS), 37% of 669 cases reported between 2006 and 2011 occurred in children under 5 years of age; approximately 28% occurred in individuals 10-24 years of age and another 28% in individuals 25 years of age and older. The median age for contracting serogroup B IMD (2009-2011) was 16 years. ⁷

The genotype of invasive serogroup B strains collected in Canada (2006-2012; n=258) as part of the Canadian Immunization Monitoring Program Active (IMPACT) surveillance network, including common epidemiological markers such as clonal complex (CC) and the fHBP variant type, has been determined.¹² All isolates were found to contain the gene that codes for fHBP, with approximately 38% of strains expressing fHBP belonging to subfamily A and 62% to subfamily B. Consistent with findings from other countries, the distribution of Canadian strains expressing subfamily A and B differed as a function of patient age. Compared with adolescents and young adults, considerably more meningococcal disease in infants < 1 year of age and in patients ≥65 years of age was due to serogroup B isolates expressing subfamily A fHBP variants. Additionally, meningococcal carriage strains predominantly express subfamily A fHBP variants.¹³ A total of 50 different fHBP variants were identified in the IMPACT collection of MnB strains; however, 80% of the isolates expressed 1 of the following 10 most prevalent fHBP variants: B44, A22, B16, B09, A19, A05, A20, A12, B03, B24 (listed in order of decreasing prevalence). The CC profile of the Canadian MnB invasive isolates from 2006-2012 was largely composed of CC269 and CC41/44, representing approximately 39% and 29% of the total collection, respectively. Unlike IMD in other provinces, cases associated with the Quebec epidemic have been dominated by CC269 serogroup B strains,¹¹ the majority of which express fHBP variant B44.

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Each dose (0.5 mL) of vaccine contains:
Neisseria meningitidis serogroup B rLP2086 subfamily A	60 micrograms
Neisseria meningitidis serogroup B rLP2086 subfamily B	60 micrograms

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TRUMENBA Quick Finder

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SUMMARY PRODUCT INFORMATION

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Indications And Clinical Use

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General

Hematologic

Immune

Sexual Function/Reproduction

Pregnant Women:

Nursing Women:

Pediatrics (< 10 years of age):

Geriatrics (> 65 years of age):

Adverse Reactions

Adverse Drug Reaction Overview

Clinical Trial Adverse Drug Reactions

Post-Market Adverse Reactions

Drug Interactions

Drug-Drug Interactions

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Dosage And Administration

Recommended Dose and Dosage Adjustment

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TRUMENBA (meningococcal group B vaccine)

TRUMENBA Quick Finder

Health Professional Information

SUMMARY PRODUCT INFORMATION

Description

Indications And Clinical Use

Contraindications

Warnings And Precautions

General

Hematologic

Immune

Sexual Function/Reproduction

Pregnant Women:

Nursing Women:

Pediatrics (< 10 years of age):

Geriatrics (> 65 years of age):

Adverse Reactions

Adverse Drug Reaction Overview

Clinical Trial Adverse Drug Reactions

Post-Market Adverse Reactions

Drug Interactions

Drug-Drug Interactions

Drug-Lifestyle Interactions

Dosage And Administration

Recommended Dose and Dosage Adjustment

Administration

Overdosage

Action And Clinical Pharmacology

Mechanism of Action

Epidemiology

Storage And Stability

Special Handling Instructions

Dosage Forms, Composition And Packaging

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