Vaccine Information: Trumenba (Page 3 of 3)

14.2 Concomitant Vaccine Administration

Study B1971011 (Study 1011) evaluated the immunogenicity of concomitantly administered Trumenba and Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co, Inc.). U.S. subjects 11 through 17 years of age were randomized into three groups: Group 1 received Trumenba and HPV4 (N=992), Group 2 received Trumenba and saline (N=990), and Group 3 received saline and HPV4 (N=501). All vaccines were administered according to a 0-, 2- and 6-month schedule. Immune responses were evaluated by comparisons of geometric mean titer [GMT] for each HPV type at 1 month after the third HPV4 vaccination (Group 1 vs. Group 3), and hSBA GMTs using two meningococcal serogroup B strains [variants A22 and B24] 1 month after the third Trumenba vaccination (Group 1 vs. Group 2). The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (Group 1/Group 3 for HPV and Group 1/Group 2 for meningococcal serogroup B strains) >0.67] were met for three HPV types (6, 11 and 16) and for the meningococcal serogroup B strains tested. For HPV-18, the lower bound of the 95% CI for the GMT ratio was 0.62 at 1 month after the third HPV4 vaccination

Study B1971015 (Study 1015) evaluated the immunogenicity of concomitantly administered Trumenba and Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY) (Sanofi Pasteur Inc.) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.) vaccines. U.S. subjects 10 through 12 years of age were randomized into three groups: Group 1 received Trumenba at 0, 2, and 6 months, and MenACWY and Tdap were coadministered with the first Trumenba dose (N=883). Group 2 received saline at 0, 2 and 6 months, and MenACWY and Tdap were coadministered with the first saline injection (N=870). Group 3 received Trumenba at 0, 2 and 6 months, and saline was coadministered with the first Trumenba dose (N=875). Immune responses were evaluated by comparisons of GMTs for each of the MenACWY and Tdap antigens 1 month after the first Trumenba vaccination, and hSBA GMTs using two meningococcal serogroup B strains [variants A22 and B24] 1 month after the third Trumenba vaccination. The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% CI of the GMT ratio (Group 1/Group 3 for meningococcal serogroup B strains and Group 1/Group 2 for MenACWY and Tdap) >0.67] were met for all antigens.

15 REFERENCES

1.

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

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Trumenba is supplied in the following strengths and package configurations:

Prefilled Syringe, 1 Dose (10 per package) – NDC 0005-0100-10.

Prefilled Syringe, 1 Dose (5 per package) – NDC 0005-0100-05.

Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-0100-02 (This Package Not for Sale).

After shipping, Trumenba may arrive at temperatures between 2°C to 25°C (36°F to 77°F).

The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

16.2 Storage and Handling

Upon receipt, store refrigerated at 2°C to 8°C (36°F to 46°F).

Store syringes in the refrigerator horizontally (laying flat on the shelf) to minimize the re-dispersion time.

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

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, the healthcare professional should inform the individual, parent, guardian, or other responsible adult of the following:

•

The importance of completing the immunization series.

•

Report any suspected adverse reactions to a healthcare professional.

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

U.S. Govt. License No. 3

LAB-0722-10.0

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

NDC 0005-0100-01
Rx only

Meningococcal
Group B Vaccine

Trumenba^®

One Dose (0.5 mL) FOR IM USE ONLY
REFRIGERATE
DO NOT FREEZE
SHAKE VIGOROUSLY
Wyeth Pharm. LLCUS Govt. License No. 3

PRINCIPAL DISPLAY PANEL — 5 — 0.5 mL Syringe Carton

NDC 0005-0100-05

Meningococcal
Group B Vaccine

Trumenba^®

For use in individuals
10 through 25 years of age

5 One-Dose (0.5 mL) Prefilled Syringes

FOR INTRAMUSCULAR USE ONLY

Pfizer

Rx only

PRINCIPAL DISPLAY PANEL — 10 — 0.5 mL Syringe Carton

NDC 0005-0100-10

Meningococcal
Group B Vaccine

Trumenba^®

For use in individuals
10 through 25 years of age

10 One-Dose (0.5 mL)Prefilled Syringes

FOR INTRAMUSCULAR USE ONLY

Pfizer

Rx only

PRINCIPAL DISPLAY PANEL — 1 — 0.5 mL Syringe Carton

NDC 0005-0100-02

THIS PACKAGE NOT FOR SALE

Meningococcal Group B Vaccine

Trumenba^®

For use in individuals 10 through 25 years of age

1 One-Dose (0.5 mL) Prefilled Syringe

FOR INTRAMUSCULAR USE ONLY

Pfizer

Rx only

TRUMENBA meningococcal group b vaccine injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:0005-0100 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN (NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN) NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN 60 ug in 0.5 mL NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN (NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN) NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN 60 ug in 0.5 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 0.018 mg in 0.5 mL ALUMINUM PHOSPHATE 0.25 mg in 0.5 mL HISTIDINE SODIUM CHLORIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0005-0100-05 5 SYRINGE in 1 CARTON contains a SYRINGE (0005-0100-01) 1 NDC:0005-0100-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-0100-05) 2 NDC:0005-0100-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0005-0100-01) 2 NDC:0005-0100-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-0100-10) 3 NDC:0005-0100-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0005-0100-01) 3 NDC:0005-0100-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-0100-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125549 11/05/2014

Labeler — Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Ireland Pharmaceuticals		985586408	ANALYSIS (0005-0100), MANUFACTURE (0005-0100), API MANUFACTURE (0005-0100)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Health AB		354433591	ANALYSIS (0005-0100), API MANUFACTURE (0005-0100)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Manufacturing Belgium NV		370156507	ANALYSIS (0005-0100), MANUFACTURE (0005-0100), PACK (0005-0100), LABEL (0005-0100)

Revised: 12/2022 Wyeth Pharmaceutical Division of Wyeth Holdings LLC