Vaccine Information: Trumenba (Page 3 of 3)

14.2 Concomitant Vaccine Administration

Study 4 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 to <18 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 one month after the third HPV4 vaccination.

Study 5 evaluated the immunogenicity of concomitantly administered Trumenba and Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (MCV4) (Sanofi Pasteur Inc.) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.) vaccines. U.S. subjects 10 to <13 years of age were randomized into three groups: Group 1 received Trumenba at 0, 2, and 6 months, and MCV4 and Tdap were coadministered with the first Trumenba dose (N=883). Group 2 received saline at 0, 2 and 6 months, and MCV4 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 MCV4 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 MCV4 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).

Logo
(click image for full-size original)

U.S. Govt. License No. 3

LAB-0722-9.0
CPT Code 90621

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. IncUS Govt. License No. 3

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

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

Pfizer
FOR INTRAMUSCULAR USE ONLYRx only

PRINCIPAL DISPLAY PANEL -- 5 -- 0.5 mL Syringe Carton
(click image for full-size original)

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

Pfizer
FOR INTRAMUSCULAR USE ONLYRx only

PRINCIPAL DISPLAY PANEL -- 10 -- 0.5 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 — 0.5 mL Syringe Carton

NDC 0005-0100-02

THIS PACKAGE NOT FOR SALE

MeningococcalGroup B Vaccine

Trumenba®

For use in individuals 10 through 25 years of age

Pfizer

1 One-Dose (0.5 mL) Prefilled Syringe

FOR INTRAMUSCULAR USE ONLY

Rx only

PRINCIPAL DISPLAY PANEL -- 1 -- 0.5 mL Syringe Carton
(click image for full-size original)
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 SEROGROUP 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 SEROGROUP 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), API MANUFACTURE (0005-0100), MANUFACTURE (0005-0100), PACK (0005-0100)
Establishment
Name Address ID/FEI Operations
Pfizer Health AB 354433591 API MANUFACTURE (0005-0100)
Establishment
Name Address ID/FEI Operations
John Wyeth & Brother Limited 215193306 LABEL (0005-0100), PACK (0005-0100)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (0005-0100), LABEL (0005-0100), PACK (0005-0100)

Revised: 11/2020 Wyeth Pharmaceutical Division of Wyeth Holdings LLC

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