Penbraya

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Description for Penbraya

PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine) is a suspension for intramuscular injection. PENBRAYA is supplied as a sterile Lyophilized MenACWY Component to be reconstituted with the sterile MenB Component.

The Lyophilized MenACWY Component consists of N. meningitidis serogroups A, C, W, and Y polysaccharides individually conjugated to TT. The polysaccharide for each group is grown in media containing dextrose, salt, and yeast extract, then purified by precipitation and filtration. The TT is produced by fermentation of Clostridium tetani in dextrose, salts, and tryptone N1 peptone followed by formalin detoxification, then purified by a series of physicochemical steps. The serogroups A and C polysaccharides are individually microfluidized, activated with 1-cyano-4(dimethylamino)-pyridinium tetrafluorobate (CDAP), derivatized with adipic acid dihydrazide (ADH), and then conjugated with TT in the presence of 1-ethyl-3-(3- dimethylaminopropyl)carbodiimide) (EDAC). The serogroups W and Y polysaccharides are individually microfluidized, activated with CDAP, and then conjugated with TT. The conjugates are purified by a series of physicochemical steps then sterile filtered. Trometamol/sucrose buffer is added, and the MenACWY-TT solution is lyophilized.

The MenB Component is a sterile suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, 1 from fHbp subfamily A and 1 from fHbp subfamily B (A05 and B01, respectively). The proteins are individually produced in Escherichia coli. Production strains are grown to a specific density in chemically defined fermentation growth media without antibiotics or animal-derived components. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added and is present in the MenB Component.

Each approximately 0.5 mL dose of PENBRAYA contains N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid), 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein), L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0.

PENBRAYA does not contain any preservatives.

Uses for Penbraya

PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitides serogroups A,B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.

Dosage for Penbraya

For intramuscular use only.

Dose And Schedule

Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart.

Preparation

PENBRAYA is supplied in a kit that includes a vial of Lyophilized MenACWY Component (a sterile white powder), a prefilledsyringe containing the MenB Component and a vial adapter.

To form PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component as described in theinstructions below.

Step 1. Attachment of the vial adapter to the vial.

• Remove the flip top cap from the vial of Lyophilized MenACWY Component.
• Peel off the top cover from the vial adapter packaging.
• While keeping the vial adapter in its packaging, center the adapter over the vial’s stopperand attach to the vial with a straight downward push.
• Remove the packaging.

Step 2. Resuspension of the MenB Component.

• Shake the syringe containing the MenB Component vigorously to obtain a whitehomogenous suspension. Do not use if the contents cannot be resuspended.

Step 3. Connection of the syringe containing the MenB Component to the vial adapter.

• Hold the syringe by the Luer lock adapter.
• Twist to remove the syringe cap.
• Connect the syringe to the vial adapter by turning the Luer lock.

Step 4. Reconstitution of the Lyophilized MenACWY Component with the MenBComponent to form PENBRAYA.

• Inject the entire contents of the syringe into the vial.
• Hold the plunger rod down and gently swirl the vial until the powder is completelydissolved (less than 1 minute).

Step 5. Withdrawal of PENBRAYA.

• Invert the vial completely and slowly withdraw the entire contents into the syringe for anapproximately 0.5 mL dose of PENBRAYA.
• Twist to disconnect the syringe from the vial adapter.
• Attach a sterile needle suitable for intramuscular injection.

Administration

For intramuscular use only.

After reconstitution, PENBRAYA is a homogeneous white suspension. If the vaccine is not a homogenous suspension, shake toresuspend prior to administration. Parenteral drug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit. Discard if either condition is present.

Administer PENBRAYA immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4 hours. Discardreconstituted vaccine if not used within 4 hours.

HOW SUPPLIED

Dosage Forms And Strengths

PENBRAYA is a suspension for injection.

Storage And Handling

PENBRAYA is supplied in a kit that includes a vial of Lyophilized MenACWY Component (NDC 0069-0271-01), a prefilledsyringe containing MenB Component (NDC 0069-0332-01) and a vial adapter. The Lyophilized MenACWY Component isreconstituted with the MenB Component to form a single dose of PENBRAYA.

PENBRAYA is supplied in cartons of 1, 5, and 10 kits.

Carton: 1 kit	0069-0600-01
Carton: 5 kits	0069-0600-05
Carton: 10 kits	0069-0600-10

The vial stopper and the syringe tip cap and plunger stopper are not made with natural rubber latex.

Storage Before Reconstitution

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. During storage, a white deposit and clear supernatantmay be observed in the prefilled syringe containing the MenB Component. Store the carton horizontally to minimize the time necessary to resuspend the MenB Component.

Do not freeze. Discard if the carton has been frozen.

Storage After Reconstitution

After reconstitution, administer PENBRAYA immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4hours. Do not freeze.

Manufactured by: Pfizer Ireland Pharmaceuticals, Ringaskiddy, Cork, Ireland. Revised: Nov 2024

Side Effects for Penbraya

The most commonly reported (≥15%) solicited adverse reactions after Dose 1 and Dose 2, respectively, were pain at theinjection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection siteredness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%).

Clinical Trials Experience

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

The safety of PENBRAYA in individuals 10 through 25 years of age was evaluated in 3 clinical studies (2 active-controlledand 1 non-controlled study). In the controlled studies, 2306 participants received at least 1 dose of PENBRAYA. Of 946participants who had previously received a meningococcal conjugate vaccine (categorized as MenACWY conjugate vaccine-exposed), 802 participants had received 1 dose of any U.S.-licensed Meningococcal Groups A, C, W, and Y conjugate vaccine,51 participants had received a non-U.S.-licensed monovalent Meningococcal Group C conjugate vaccine (MenC conjugatevaccine), and 93 participants had received an unspecified U.S.-licensed or non-U.S.-licensed MenACWY conjugate or a MenC conjugate vaccine at least 4 years prior to enrollment. In the non-controlled study, 300 participants received a single dose ofPENBRAYA.

Study 1 (NCT04440163) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=1763) or Meningococcal Group B Vaccine(Trumenba) (N=650) at 0 and 6 months. Meningococcal Groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM

Conjugate Vaccine (MenACWY-CRM, GSK Vaccines, SRL) was concomitantly administered with Trumenba at Month 0. Allparticipants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposedparticipants were part of the study.

Study 2 (NCT03135834) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=543) or Trumenba (N=1057) at 0 and 6months. MenACWY-CRM was co-administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. BothMenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposed participants were part of this study.

Study 3 (NCT04440176) was a descriptive non-controlled study in which participants 11 through 14 years of age in the U.S.received PENBRAYA 12 months apart. All participants were naïve to any meningococcal vaccine.

In Study 1 and Study 2, solicited local and systemic adverse reactions were monitored for 7 days after study vaccination usingan electronic diary. In all studies, spontaneous reports of adverse events (AEs) were collected through at least 1 month after thelast vaccination, and through 6 months after the last vaccination for serious adverse events (SAEs).

In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity amongparticipants who received PENBRAYA and those who received control (Trumenba and MenACWY-CRM). Amongparticipants who received PENBRAYA in controlled studies, 47.4% were male, 79.4% were White, 10.2% were Black orAfrican-American, 2.1% were Asian, and 2.6% were of other racial groups, and 21.6% were of Hispanic/Latino ethnicity.

Solicited Local and Systemic Adverse Reactions

Table 1 presents the solicited local adverse reactions and Table 2 presents the solicited systemic adverse reactions and use ofantipyretic medication reported within 7 days following each dose of PENBRAYA in Study 1.

Table 1: Percentage of Participants Reporting Solicited Local Adverse Reactions Within 7 Days After PENBRAYA orTrumenba Vaccination in Study I*

Injection Site Reactions	PENBRAYA		Trumenba + MenACWY-CRMt
	Dose 1 N=1724-1725 %	Dose 2 N=1456 %	Dose 1 N=630-631 %	Dose 2 N=529 %
Pain‡
Any§	89.3	84.4	85.1	78.6
Mild	32.3	29.1	31.1	33.1
Moderate	49.4	48.8	47.7	40.3
Severe	7.5	6.5	6.3	5.3
Redness¶
Any§	25.9	23.2	19.5	14.7
Mild	8.9	7.7	7.3	6.6
Moderate	14.4	12.6	10.0	7.2
Severe	2.6	3.0	2.2	0.9
Swelling¶
Any§	25.0	24.2	21.4	14.7
Mild	10.6	10.4	8.3	6.4
Moderate	13.3	12.8	12.4	8.1
Severe	1.2	1.0	0.8	0.2
Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharidediphtheria CRM197 conjugate vaccine; Trumenba = meningococcal serogroup B factor H binding protein. *NCT04440163 †Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. Local reactions were recordedonly for PENBRAYA and Trumenba injection sites. ‡Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity). §“Any” is defined as the cumulative frequency of participants who reported a reaction as “mild”, “moderate”, or “severe” within 7 days ofvaccination. ¶Mild (2.0 to 5 cm); Moderate (>5 to 10 cm); Severe (>10 cm).

Table 2: Percentage of Participants Reporting Solicited Systemic Adverse Reactions and Use of Antipyretic MedicationsWithin 7 Days After Each Vaccination in Study 1

Systemic Reactions	PENBRAYA		Trumenba + MenACWY-CRM*
	Dose 1 N=1739-1740 %	Dose 2 N=1459 %	Dose 1 N=638 %	Dose 2 N=532 %
Fever (≥38°C)
≥38.0°C	5.9	2.4	5.8	1.5
38.0° to 38.4°C	3.7	1.9	2.0	0.4
>38.4° to 38.9°C	1.6	0.3	2.8	0.9
>38.9° to 40.0°C	0.6	0.2	0.9	0.2
>40.0°C	0.0	0.0	0.0	0.0
Vomiting†
Any‡	3.2	1.5	3.0	0.9
Mild	2.5	1.4	2.0	0.8
Moderate	0.6	0.1	0.9	0.2
Severe	0.0	0.0	0.0	0.0
Diarrhea§
Any‡	11.0	8.2	13.5	8.5
Mild	8.7	6.9	11.9	6.0
Moderate	2.0	1.4	1.6	2.4
Severe	0.3	0.0	0.0	0.0
Headache¶
Any‡	46.8	39.8	46.9	37.8
Mild	25.7	21.3	24.5	21.1
Moderate	19.2	16.8	20.4	16.2
Severe	1.9	1.7	2.0	0.6
Fatigue¶
Any‡	52.1	47.6	54.7	43.6
Mild	23.5	22.8	25.7	22.0
Moderate	25.5	21.8	25.7	19.9
Severe	3.2	2.9	3.3	1.7
Chills¶
Any‡	20.1	16.4	19.6	16.2
Mild	12.6	9.9	10.2	8.8
Moderate	6.7	6.0	7.8	5.8
Severe	0.8	0.4	1.6	1.5
Muscle pain (other than muscle pain at the injection site)¶
Any‡	25.7	22.8	27.4	22.2
Mild	13.6	10.0	13.5	10.0
Moderate	10.5	11.9	11.9	11.5
Severe	1.6	0.8	2.0	0.8
Joint pain¶
Any‡	20.2	18.3	22.6	15.6
Mild	10.7	9.6	12.9	7.9
Moderate	8.6	8.3	8.6	6.8
Severe	1.0	0.4	1.1	0.9
Use of antipyretic medication	29.5	25.1	28.1	20.5
Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharidediphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. *Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. †Mild (1 to 2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (requires intravenous hydration). ‡“Any” is defined as the cumulative frequency of participants who reported a reaction as “mild”, “moderate”, or “severe” within 7 days ofvaccination. §Mild (2 to 3 loose stools in 24 hours); Moderate (4 to 5 loose stools in 24 hours); Severe (6 or more loose stools in 24 hours). ¶Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).

Serious Adverse Events

In Study 1, during the 30 days after vaccination visit 1 (at 0 months), <0.1% (1/1763) of PENBRAYA and 0% (0/649) ofTrumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months),0.1% (2/1558) of PENBRAYA and 0% (0/562) of Trumenba participants reported at least 1 SAE. None of the SAEs weredetermined to be related to PENBRAYA vaccination.

In Study 2, during the 30 days after vaccination visit 1 (at 0 months), 0.4% (2/543) of PENBRAYA and 0% (0/1057) ofTrumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months),0.2% (1/486) of PENBRAYA and 0% (0/946) of Trumenba participants reported at least 1 SAE. None of the SAEs weredetermined to be related to PENBRAYA vaccination.

In non-controlled Study 3, no SAEs (0/294) were reported within 30 days after either vaccination (0, 12 months).

Postmarketing Experience

The postmarketing safety experience with Trumenba and a non-U.S.-licensed Meningococcal Groups A, C, W, and Ypolysaccharide tetanus toxoid (TT) conjugate vaccine (MenACWY-TT vaccine; Pfizer Inc.) is relevant to PENBRAYA sincePENBRAYA includes the same group A, C, W, and Y TT-conjugated polysaccharide components and MenB recombinantprotein components. Because these events are reported voluntarily from a population of uncertain size, it is not possible toreliably estimate their frequency or establish a causal relationship to vaccination. The following adverse reactions have beenspontaneously reported during postmarketing use of Trumenba and MenACWY-TT and may also be seen in postmarketingexperience with PENBRAYA.

Immune System Disorders: allergic reactions, including anaphylaxis

Nervous System: syncope (fainting)

Drug Interactions for Penbraya

No Information provided

Warnings for Penbraya

Included as part of the PRECAUTIONS section.

Precautions for Penbraya

Management Of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event ananaphylactic reaction occurs following administration of PENBRAYA.

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including PENBRAYA. Proceduresshould be in place to avoid injury from fainting.

Altered Immunocompetence

Reduced Immune Response

Some individuals with altered immunocompetence may have reduced immune responses to PENBRAYA.

Complement Deficiency

Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complementactivation are at increased risk for invasive disease caused by N. meningitides groups A, B, C, W, and Y, even if they developantibodies following vaccination with PENBRAYA [see CLINICAL PHARMACOLOGY].

Limitations Of Vaccine Effectiveness

Vaccination with PENBRAYA may not protect all vaccine recipients.

Tetanus Immunization

Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid containing vaccine to prevent tetanus.

Guillain-Barré Syndrome

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensedmeningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administerPENBRAYA to persons with a history of GBS should take into account the expected benefits and potential risks.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

PENBRAYA has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PENBRAYA duringpregnancy. Individuals who received PENBRAYA during pregnancy are encouraged to contact, or have their healthcareprovider contact, 1-877-390-2953 to enroll in or obtain information about the registry.

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimatedbackground risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,respectively.

There are no clinical studies of PENBRAYA in pregnant individuals. Available human data on PENBRAYA administered topregnant individuals are insufficient to inform vaccine-associated risks in pregnancy.

There were no developmental toxicity studies performed with PENBRAYA.

Lactation

Risk Summary

There are no data available to assess the effects of PENBRAYA on the breastfed infant or on milk production/excretion. Thedevelopmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PENBRAYAand any potential adverse effects on the breastfed child from PENBRAYA or from the underlying maternal condition. Forpreventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

The safety and effectiveness of PENBRAYA have not been established in individuals <10 years of age. In a clinical study, 90%of infants younger than 12 months of age who were vaccinated with a reduced dosage formulation of Trumenba had fever.PENBRAYA contains the same MenB component, in the same quantity, as Trumenba.

Geriatric Use

The safety and effectiveness of PENBRAYA have not been established in individuals >65 years of age.

Overdose Information for Penbraya

No Information provided

Contraindications for Penbraya

Do not administer PENBRAYA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA [see DESCRIPTION].

Clinical Pharmacology for Penbraya

Mechanism Of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis.¹ Vaccination with PENBRAYA induces the production of bactericidal antibodies specific to the capsularpolysaccharides of N. meningitidis serogroups A, C, W, and Y and to fHbp subfamily A and B variants of N. meningitidis groupB. The susceptibility of group B meningococci to bactericidal antibody is dependent upon both the antigenic similarity of thefHbp subfamily A or subfamily B vaccine antigen to the fHbp protein expressed by the bacterial strain and the amount of fHbpexpressed at the bacterial surface.²

Clinical Studies

The effectiveness of PENBRAYA was assessed in Study 1 by measuring antibodies with assays that used human complementto assess serum bactericidal activity (hSBA). For serogroups A, C, W, and Y, one strain was utilized per group. For serogroupB, four meningococcal serogroup B strains expressing different fHbp variants that represent the A and B subfamilies ofmeningococcal serogroup B strains causing invasive disease in the U.S. and Europe were utilized. The proportions of subjectswith a 4-fold or greater increase in hSBA titer for each strain, and the proportion of subjects with a titer greater than or equal tothe lower limit of quantitation (LLOQ) of the assay for all four serogroup B strains (composite response) were assessed.

Immunogenicity

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study in which participants 10 through 25years of age in the U.S. and Europe received PENBRAYA at 0 and 6 months or Trumenba at 0 and 6 months and MenACWY-CRM at 0 months. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine -naïve and MenACWYconjugate vaccine-exposed participants were part of the study.

Seroresponse for serogroups A, B, C, W, and Y and composite response for serogroup B following 2 doses of PENBRAYA inStudy 1 are presented in Tables 3 and 4.

Among both ACWY-naïve and ACWY-exposed participants, seroresponse rates to serogroups A, C, W, and Y following 2doses of PENBRAYA were demonstrated to be non-inferior to seroresponse rates following a single dose of MenACWY-CRM.Seroresponse and composite response rates to serogroup B primary strains among participants who received 2 doses ofPENBRAYA were demonstrated to be non-inferior to seroresponse and composite response rates following 2 doses ofTrumenba.

Table 3: Percentage of Subjects Achieving Seroresponses 1 Month after Receiving 2 Doses of PENBRAYA (0 and 6Months) versus 1 Month after Single Dose of MenACWY-CRM for Serogroups A, C, W, and Y (Study 1)*,†

Serogroup	PENBRAYA %	Trumenba + MenACWY-CRM %	PENBRAYA - MenACWY-CRM Difference‡
	N=439-451 (Naive) N=376-387 (Exposed)	N=244-254 (Naive) N=222-227 (Exposed)	Difference % (95% CI)
A
ACWY-naive	97.8	95.3	2.5 (-0.2, 6.0)
ACWY-exposed	93.8	96.9	-3.2 (-6.5, 0.5)
C
ACWY-naive	93.3	52.4	41.0 (34.4, 47.5)
ACWY-exposed	93.8	94.7	-0.9 (-4.6, 3.3)
W
ACWY- naive	97.3	73.0	24.3 (18.8, 30.4)
ACWY-exposed	97.1	96.4	0.7 (-2.2, 4.3)
Y
ACWY- naive	94.4	70.6	23.8 (18.0, 30.1)
ACWY-exposed	93.0	93.7	-0.7 (-4.6, 3.8)
Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit ofquantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharidediphtheria CRM conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, aresponse is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a responseis defined as an hSBA titer ≥4 times the baseline titer. *Evaluable immunogenicity populations. †NCT04440163 ‡Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination serogroups.

Table 4: Percentage of Participants Achieving Seroresponses and Composite Response 1 Month after Receiving 2 Doses of PENBRAYA (0 and 6 Months) versus 2 Doses of Trumenba (0 and 6 Months) For Serogroup B (Study 1)*,†

Serogroup B Variant	PENBRAYA % N=755-845	Trumenba + MenACWY-CRM % N=383-419	PENBRAYA - Trumenba Difference Difference % (95% CI)
Seroresponse‡
A22	83.0	79.0	4.0 (-0.7, 8.9)
A56	95.9	94.5	1.4 (-1.0, 4.3)
B24	68.1	57.2	10.9 (5.2, 16.6)
B44	86.5	79.2	7.3 (2.9, 11.9)
Composite§
Pre-Dose 1	1.2	2.0	-
Post-Dose 2	78.3	68.7	9.6 (4.2, 15.2)
Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit ofquantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharidediphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, aresponse is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a responseis defined as an hSBA titer ≥4 times the baseline titer. *Evaluable immunogenicity populations. †NCT04440163 ‡Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination serogroups. §Composite response = hSBA ≥ LLOQ for all 4 primary meningococcal B strains.

REFERENCES

1 Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoralantibodies. J Exp Med. (1969);129:1307–1326.

2 Wang X, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidisisolates in the U.S. Vaccine 2011; 29:4739-4744.

Patient Information for Penbraya

Prior to administration of PENBRAYA:

• Inform vaccine recipient of the potential benefits and risks of vaccination with PENBRAYA.
• Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse EventReporting System at 1-800-822-7967 and https://vaers.hhs.gov/.