Vaccine Information: VAXNEUVANCE (Page 4 of 4)

14.3 Concomitant Vaccination

Children

In Study 8, the concomitant administration of Pentacel with each of the 3 infant doses of either VAXNEUVANCE (N=598) or Prevnar 13 (N=601) was evaluated 30 days following the third dose; concomitant administration of single doses of VAQTA, M-M-R II, VARIVAX and Hiberix with the fourth dose of either VAXNEUVANCE or Prevnar 13 was evaluated 30 days following vaccination. There was no evidence that VAXNEUVANCE, as compared to Prevnar 13, interfered with the immune responses to these concomitantly administered vaccines. The immune responses to the antigens in Pentacel following completion of the 4-dose series were not evaluated.

In Study 9, the concomitant administration of RECOMBIVAX HB with either VAXNEUVANCE (N=124) or Prevnar 13 (N=266) was evaluated 30 days following the third dose of pneumococcal conjugate vaccine. Most infants (97.2%) received a birth dose of hepatitis B vaccine, followed by two doses of RECOMBIVAX HB administered concomitantly with VAXNEUVANCE or Prevnar 13. There was no evidence that VAXNEUVANCE, as compared to Prevnar 13, interfered with the immune response to RECOMBIVAX HB.

Adults

In a double-blind, randomized study (Study 6), adults 50 years of age and older were randomized to receive VAXNEUVANCE concomitantly administered with a seasonal inactivated quadrivalent influenza vaccine (Fluarix Quadrivalent; QIV) (Group 1, N=600) or VAXNEUVANCE 30 days after receiving QIV (Group 2, N=600) [see Adverse Reactions (6.1)]. Pneumococcal vaccine serotype OPA GMTs were evaluated 30 days after VAXNEUVANCE and influenza vaccine strain hemagglutinin inhibition assay (HAI) GMTs were evaluated 30 days after QIV. 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 2) >0.5] were met for the 15 pneumococcal serotypes in VAXNEUVANCE and for the 4 influenza vaccine strains tested.

16 HOW SUPPLIED/STORAGE AND HANDLING

VAXNEUVANCE is supplied as follows:

Carton of one 0.5 mL single-dose prefilled Luer Lock syringes with tip caps. NDC 0006-4329-02

Carton of ten 0.5 mL single-dose prefilled Luer Lock syringes with tip caps. NDC 0006-4329-03

Store refrigerated at 2°C to 8°C (36°F to 46°F).

Do not freeze. Protect from light.

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

17 PATIENT COUNSELING INFORMATION

Advise the patient, parent or guardian to read the FDA-approved patient labeling (Patient Information).

Discuss the following with the patient, parent or guardian:

  • Provide the required vaccine information to the patient, parent or guardian.
  • Inform the patient, parent or guardian of the benefits and risks associated with vaccination.
  • Inform the patient, parent or guardian that vaccination with VAXNEUVANCE may not protect all vaccine recipients.
  • Discuss the importance of completing the vaccination series unless contraindicated.
  • Instruct the patient, parent or guardian to report any serious adverse reactions to their healthcare provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov.

Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

U.S. license number 0002

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2021-2022 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

uspi-v114-i-2206r001

Patient InformationVAXNEUVANCE™ (pronounced “VAKS-noo-vans”)(Pneumococcal 15-valent Conjugate Vaccine)

Before you get VAXNEUVANCE™, read this information sheet and be sure you understand it. If you have questions or experience any side effects, talk to your healthcare provider. This information does not take the place of talking about VAXNEUVANCE with your healthcare provider. Your healthcare provider will decide if VAXNEUVANCE is right for you or your child.

What is VAXNEUVANCE?

  • VAXNEUVANCE is a vaccine to help protect against invasive disease caused by 15 types of pneumococcus (pronounced “noo-mo-ca-cus”), a kind of bacteria. Invasive disease includes:
    • an infection in the blood (bacteremia).
    • an infection of the coverings of the brain and spinal cord (meningitis).
  • VAXNEUVANCE is for individuals 6 weeks of age and older.
  • VAXNEUVANCE will not give you or your child disease caused by pneumococcus.
  • VAXNEUVANCE might not protect everyone who gets the vaccine.

Who should not get VAXNEUVANCE?

Do not get VAXNEUVANCE if you or your child:

  • have or had an allergic reaction to any of the ingredients in VAXNEUVANCE or to diphtheria toxoid. (See the list of ingredients at the end of this information sheet.)

What should I tell my healthcare provider before getting VAXNEUVANCE?

Tell your healthcare provider if you or your child:

  • have or had an allergic reaction to any vaccine.
  • have a weak immune system (which means the body has a hard time fighting off infections).
  • take medicines or treatments that might weaken the immune system (like immunosuppressants or steroids).
  • are pregnant or planning to get pregnant.
  • are breast-feeding.

If your child is an infant, also tell your healthcare provider if your child was born too early (prematurely).

How is VAXNEUVANCE given?

VAXNEUVANCE is given as an injection into the muscle (usually in the upper arm for adults and the upper arm or thigh for children).

Children need 4 doses of the vaccine:

  • The first injection is given at 2 months old.
  • The second injection is given at 4 months old.
  • The third injection is given at 6 months old.
  • The fourth injection is given at 12 through 15 months old.

If your child did not receive the complete series according to this schedule, your healthcare provider may suggest a catch-up schedule.

Your child may get VAXNEUVANCE at the same time they get other vaccines.

Adults need one dose of the vaccine.

What are the possible side effects of VAXNEUVANCE?

The most common side effects seen with VAXNEUVANCE in children less than 2 years of age are:

  • Fever
  • Pain, redness, swelling, or a lump where your child got the injection
  • More fussy than usual
  • More sleepy than usual
  • Eating less than usual

The most common side effects seen with VAXNEUVANCE in children and adolescents 2 through 17 years of age are:

  • Pain, swelling, redness or a lump where your child got the injection
  • Muscle aches
  • Feeling tired
  • Headache

The most common side effects seen with VAXNEUVANCE in adults 18 years of age and older are:

  • Pain, swelling or redness where you got the injection
  • Feeling tired
  • Muscle aches
  • Headache
  • Joint pain

In most people these side effects went away within three days.

If you or your child have any side effects that become bothersome or any other unusual symptoms that develop after getting this injection, tell your healthcare provider. Tell your healthcare provider right away if you or your child have symptoms of an allergic reaction which may include:

  • Difficulty breathing
  • Swelling of your face, lips, tongue or throat
  • Hives
  • Rash

There may be side effects that are not listed here. For more information, ask your healthcare provider.

You may also report any side effects to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.


What are the ingredients in VAXNEUVANCE?

Active ingredient: Bacterial sugars from 15 types of pneumococcus each linked to a protein (CRM197 ). The sugars from these bacteria and the protein are not alive and do not cause disease.Inactive ingredients: Sodium chloride, L-histidine, polysorbate 20 and aluminum (aluminum phosphate is included to help the vaccine work better).

VAXNEUVANCE does not have any preservatives.

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

What if I have other questions?

If you have questions about VAXNEUVANCE, talk to your healthcare provider or call the Merck National Service Center at 1-800-622-4477.

Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2021-2022 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

usppi-v114-i-2206r001

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 06/2022

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton

NDC 0006-4329-03
10 Single-dose 0.5 mL Syringes

REFRIGERATE

Pneumococcal 15-valent
Conjugate Vaccine
VAXNEUVANCE™

Suspension for intramuscular injection

Rx only

Each 0.5 mL dose contains 2.0 mcg each of Streptococcus pneumoniae
polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F,
and 4.0 mcg of polysaccharide serotype 6B, 30 mcg of CRM197 carrier protein,
and 125 mcg of aluminum as aluminum phosphate adjuvant.Contains no preservative.

MERCK

Principal Display Panel -- 0.5 mL Syringe Label
(click image for full-size original)
VAXNEUVANCE pneumococcal 15-valent conjugate vaccine crm197 protein adsorbed injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4329
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 4 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN (STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN) STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN (CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN) CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN 30 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
HISTIDINE
POLYSORBATE 20
ALUMINUM PHOSPHATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4329-03 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (0006-4329-01)
1 NDC:0006-4329-01 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0006-4329-03)
2 NDC:0006-4329-02 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (0006-4329-01)
2 NDC:0006-4329-01 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0006-4329-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125741 07/16/2021
Labeler — Merck Sharp & Dohme LLC (118446553)

Revised: 07/2022 Merck Sharp & Dohme LLC

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