Meningococcal Group B Vaccine (2 dose)

Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief:  Martin Nino [2]

## Disclaimer

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## Overview

Meningococcal Group B Vaccine (2 dose) is a vaccine that is FDA approved for the prevention of invasive disease caused by Neisseria meningitidis serogroup B. Common adverse reactions include pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥ 28%), nausea (≥18%), and arthralgia (≥13%).

## Adult Indications and Dosage

### FDA-Labeled Indications and Dosage (Adult)

###### Indications

Meningococcal Group B Vaccine is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Meningococcal Group B Vaccine is approved for use in individuals 10 through 25 years of age.

Approval of Meningococcal Group B Vaccine is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of Meningococcal Group B Vaccine against diverse serogroup B strains has not been confirmed.

###### Dosage

* For intramuscular use only.
* Administer two doses (0.5 mL each) of Meningococcal Group B Vaccine at least 1 month apart.

Use of Meningococcal Group B Vaccine with other Meningococcal Group B Vaccines:

Sufficient data are not available on the safety and effectiveness of using Meningococcal Group B Vaccine and other meningococcal group B vaccines interchangeably to complete the vaccination series.

### Off-Label Use and Dosage (Adult)

#### Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in adult patients.

#### Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in adult patients.

## Pediatric Indications and Dosage

### FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness of Meningococcal Group B Vaccine have not been established in children younger than 10 years of age.

### Off-Label Use and Dosage (Pediatric)

#### Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in pediatric patients.

#### Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in pediatric patients.

## Contraindications

Hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of Meningococcal Group B Vaccine.

## Warnings

###### Preventing and Managing Allergic Reactions

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

###### Syncope

Syncope (fainting) can occur in association with administration of Meningococcal Group B Vaccine. Ensure procedures are in place to avoid injury from falling associated with syncope.

###### Latex

The tip caps of the pre-filled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.

###### Limitation of vaccine effectiveness

Meningococcal Group B Vaccine may not protect all vaccine recipients. Meningococcal Group B Vaccine may not provide protection against all meningococcal serogroup B strains.

###### Altered Immunocompetence

Individuals with altered immunocompetence may have reduced immune responses to Meningococcal Group B Vaccine.

## Adverse Reactions

### Clinical Trials Experience

The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In four clinical trials, 3058 individuals 10 through 25 years of age received at least one dose of Meningococcal Group B Vaccine, 1436 participants received only Meningococcal Group B Vaccine, 2089 received only placebo or a control vaccine, and 1622 participants received a mixed regimen (placebo or control vaccine and Meningococcal Group B Vaccine).

In a randomized controlled study1 conducted in US and Poland, 120 participants 10 through 25 years of age received at least one dose of Meningococcal Group B Vaccine, including 112 participants who received 2 doses of Meningococcal Group B Vaccine 2 months apart; 97 participants received saline placebo followed by Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine]. Across groups, median age was 13 years, males comprised 49% and 60% were White; 34% were Hispanic, 4% were Black,<1% were Asian, and 2% were other.

In a second randomized controlled study2 conducted in Chile, all subjects (N=1,622) 11 through 17 years of age received at least one dose of Meningococcal Group B Vaccine. This study included a subset of 810 subjects who received 2 doses of Meningococcal Group B Vaccine 1 or 2 months apart. A control group of 128 subjects received at least 1 dose of placebo containing aluminum hydroxide. A subgroup of 128 subjects received 2 doses of Meningococcal Group B Vaccine 6 months apart. In this study, median age was 14 years, males comprised 44%, and 99% were Hispanic.

In a third randomized controlled study3 conducted in the United Kingdom (UK), 974 university students 18 through 24 years of age received at least 1 dose of Meningococcal Group B Vaccine, including 932 subjects who received 2 doses of Meningococcal Group B Vaccine 1 month apart. Comparator groups received 1 dose of Menveo followed by 1 dose of placebo containing aluminum hydroxide (N=956) or 2 doses of IXIARO (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) (N=947). Across groups, median age was 20 years, males comprised 46%, and 88% were White, 5% were Asian, 2% were Black, <1% were Hispanic, and 4% were other.

In an uncontrolled study4 conducted in Canada and Australia, 342 participants 11 through 17 years of age received at least 1 dose of Meningococcal Group B Vaccine, including 338 participants who received 2 doses of Meningococcal Group B Vaccine 1 month apart. The median age was 13 years, males comprised 55%, and 80% were White, 10% were Asian, 4% were Native American/Alaskan, and 4% were other.

Local and systemic reactogenicity data were solicited from all participants in the studies conducted in Chile, US/Poland, Canada/Australia, and in a subset of participants in the UK study. Reports of unsolicited adverse events occurring within the first 7 days after each vaccination were collected in all studies. In the US/Poland study, reports of unsolicited adverse events were collected up to one month after the second vaccination.

Reports of all serious adverse events, medically attended adverse events and adverse events leading to premature withdrawal were collected throughout the study period for the studies conducted in Chile (12 months), UK (12 months), US/Poland (8 months), and Canada/Australia (2 months).

* Solicited Adverse Reactions

The reported rates of local and systemic reactions among participants 10 through 25 years of age following each dose of Meningococcal Group B Vaccine administered 2 months apart or control in the US/Polish study1 are presented in TABLE 1.

* Table 1: Percentage of US and Polish Participants 10 through 25 Years of Age Reporting Solicited Local and Systemic Adverse Reactions within 7 Days after Meningococcal Group B Vaccine or Control, by Dose

This image is provided by the National Library of Medicine.

BEXSERO : Meningococcal Group B Vaccine's Brand name

Solicited adverse reaction rates were similar among participants 11 through 24 years of age who received Meningococcal Group B Vaccine in the other three clinical studies,2,3,4 except for severe myalgia which was reported by 3-7% of subjects. Severe pain was reported by 8% of university students in the UK3.

* Non-serious Adverse Events

In the 3 controlled studies1,2,3 (Meningococcal Group B Vaccine N=2221, control N=2204), non-serious unsolicited adverse events that occurred within 7 days of any dose were reported by 439 (20%) Meningococcal Group B Vaccine and 197 (9%) control recipients. Unsolicited adverse events that were reported among at least 2% of participants and were more frequently reported in Meningococcal Group B Vaccine recipients than in control recipients were injection site pain, headache, and injection site induration unresolved within 7 days, and nasopharyngitis.

* Serious Adverse Events

Overall, in clinical studies, among 3,058 participants 10 through 25 years of age who received at least 1 dose of Meningococcal Group B Vaccine, 66 (2.1%) participants reported serious adverse events at any time during the study. In the 3 controlled studies1,2,3 (Meningococcal Group B Vaccine N=2716, Control N=2078), serious adverse events within 30 days after any dose were reported in 23 (0.8%) Meningococcal Group B Vaccine recipients and 10 (0.5%) control recipients.

###### Additional Pre-licensure Safety Experience

In response to outbreaks of serogroup B meningococcal disease at two universities in the US, Meningococcal Group B Vaccine was administered as a 2 dose series at least 1 month apart. Information on serious adverse events was collected for a period of 30 days after each dose from 15,351 individuals 16 through 65 years of age who received at least 1 dose. Overall 50 individuals (0.3%) reported serious adverse events, including one event considered related to vaccination, a case of anaphylaxis within 30 minutes following vaccination.

### Postmarketing Experience

Adverse event reports received for Meningococcal Group B Vaccine marketed outside the US are listed below. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency, or to establish a causal relationship to vaccination. This list includes serious events or events which have suspected causal association to Meningococcal Group B Vaccine.

* General disorders and administration site conditions: Blisters at or around the injection site.

* Immune System Disorders: Allergic reactions (including anaphylactic reactions), rash, eye swelling.

* Nervous System Disorders: Syncope, vasovagal responses to injection.

## Drug Interactions

Sufficient data are not available to establish the safety and immunogenicity of concomitant administration of Meningococcal Group B Vaccine with recommended adolescent vaccines.

## Use in Specific Populations

#### Pregnancy

Pregnancy Category (FDA): B

* Reproduction studies have been performed in rabbits at doses up to 15 times the human dose on a body weight basis and have revealed no evidence of impaired fertility in females or harm to the fetus due to Meningococcal Group B Vaccine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Meningococcal Group B Vaccine should be used during pregnancy only if clearly needed.

* Pregnancy Registry for Meningococcal Group B Vaccine: Novartis Vaccines and Diagnostics Inc. maintains a pregnancy registry to monitor the fetal outcomes of pregnant women exposed to Meningococcal Group B Vaccine. Health care providers are encouraged to register women who receive Meningococcal Group B Vaccine during pregnancy by calling 1-877-683-4732.

Pregnancy Category (AUS):  There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Meningococcal Group B Vaccine (2 dose) in women who are pregnant.

#### Labor and Delivery

There is no FDA guidance on use of Meningococcal Group B Vaccine (2 dose) during labor and delivery.

#### Nursing Mothers

It is not known whether Meningococcal Group B Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Meningococcal Group B Vaccine is administered to a nursing woman.

#### Pediatric Use

Safety and effectiveness of Meningococcal Group B Vaccine have not been established in children younger than 10 years of age.

#### Geriatic Use

Safety and effectiveness of Meningococcal Group B Vaccine have not been established in adults older than 65 years of age.

#### Gender

There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) with respect to specific gender populations.

#### Race

There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) with respect to specific racial populations.

#### Renal Impairment

There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in patients with renal impairment.

#### Hepatic Impairment

There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in patients with hepatic impairment.

#### Females of Reproductive Potential and Males

There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in women of reproductive potentials and males.

#### Immunocompromised Patients

There is no FDA guidance one the use of Meningococcal Group B Vaccine (2 dose) in patients who are immunocompromised.

## Administration and Monitoring

#### Administration

Shake the syringe immediately before use to form a homogeneous suspension. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is found.

Administer Meningococcal Group B Vaccine as a 0.5 mL intramuscular injection into the deltoid muscle of the upper arm.

#### Monitoring

There is limited information regarding Meningococcal Group B Vaccine (2 dose) Monitoring in the drug label.

## IV Compatibility

There is limited information regarding the compatibility of Meningococcal Group B Vaccine (2 dose) and IV administrations.

## Overdosage

There is limited information regarding Meningococcal Group B Vaccine (2 dose) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

## Pharmacology

### Mechanism of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis. The effectiveness of Meningococcal Group B Vaccine was assessed by measuring serum bactericidal activity using human complement (hSBA).

NHBA, NadA, fHbp, and PorA are proteins found on the surface of meningococci and contribute to the ability of the bacterium to cause disease. Vaccination with Meningococcal Group B Vaccine leads to the production of antibodies directed against NHBA, NadA, fHbp, and PorA P1.4 (present in OMV). The susceptibility of serogroup B meningococci to complement-mediated antibody-dependent killing following vaccination with Meningococcal Group B Vaccine is dependent on both the antigenic similarity of the bacterial and vaccine antigens, as well as the amount of antigen expressed on the surface of the invading meningococci.

### Structure

There is limited information regarding Meningococcal Group B Vaccine (2 dose) Structure in the drug label.

### Pharmacodynamics

There is limited information regarding Meningococcal Group B Vaccine (2 dose) Pharmacodynamics in the drug label.

### Pharmacokinetics

There is limited information regarding Meningococcal Group B Vaccine (2 dose) Pharmacokinetics in the drug label.

### Nonclinical Toxicology

Meningococcal Group B Vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility.

## Clinical Studies

The immunogenicity of Meningococcal Group B Vaccine following 2 doses was evaluated in individuals 11 through 24 years of age. Serum bactericidal antibodies were measured with hSBA assays using three strains selected to measure responses to one of three vaccine antigens, either fHbp, NadA or PorA P1.4, prevalent among strains in the US. A suitable strain for assessing bactericidal activity of NHBA-specific antibodies was not available. Studies assessed the proportion of subjects who achieved a 4-fold or greater increase in hSBA titer for each of the three strains, and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all three strains (composite response). The LLOQ was defined as the lowest amount of the antibody in a sample that can be reliably quantified. Available data showed that baseline antibody titers across populations vary.

###### Immunogenicity

In a clinical trial conducted in Canada and Australia, adolescents 11 through 17 years of age received two doses of Meningococcal Group B Vaccine one month apart. The hSBA responses one month after the second dose are shown in TABLE 2.

* Table 2: Bactericidal Antibody Response Rates Following 2 Doses of Meningococcal Group B Vaccine Administered 1 Month Apart to Canadian and Australian Adolescents(a)

This image is provided by the National Library of Medicine.

In a randomized, controlled clinical trial conducted in the UK among university students 18 through 24 years of age, hSBA responses in a subset of participants who received Meningococcal Group B Vaccine were measured 1 month and 11 months after the second dose (TABLE 3).

* Table 3: Bactericidal Antibody Response Rates Following 2 Doses of Meningococcal Group B Vaccine Administered 1 Month Apart to University Students in the UK(a)

This image is provided by the National Library of Medicine.

## How Supplied

Meningococcal Group B Vaccine is supplied as a 0.5 mL suspension in a glass pre-filled syringe. The tip caps of the pre-filled syringes contain natural rubber latex, the plungers are not made with natural rubber latex.

Meningococcal Group B Vaccine product presentations are listed in TABLE 4 below:

* Table 4 Meningococcal Group B Vaccine Product Presentation

This image is provided by the National Library of Medicine.

### Storage

* Do not freeze. Discard if the vaccine has been frozen.
* Store refrigerated, at 36°F to 46°F (2°C to 8°C).
* Protect from light.
* Do not use after the expiration date.

## Images

### Drug Images

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### Package and Label Display Panel

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## Patient Counseling Information

Provide the Vaccine Information Statement. These are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Inform patients, parents or guardians about:

* The importance of completing the immunization series.
* Reporting any adverse reactions to their healthcare provider.
* Register women who receive Meningococcal Group B Vaccine while pregnant in the pregnancy registry by calling 1-877-683-4732.

## Precautions with Alcohol

Alcohol-Meningococcal Group B Vaccine (2 dose) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

## Brand Names

BEXSERO®

## Look-Alike Drug Names

There is limited information regarding Meningococcal Group B Vaccine (2 dose) Look-Alike Drug Names in the drug label.

## Drug Shortage Status

## Price

## References

The contents of this FDA label are provided by the National Library of Medicine.