Vaccine Information: PREVNAR 13 (Page 8 of 8)

14.4 Concomitant Vaccine Administration

Infants and Toddlers

The concomitant administration of routine US infant vaccines [see Drug Interactions (7.1)] with Prevnar 13 was evaluated in two studies: Study 2 [see Clinical Studies (14.2)] , Pneumococcal Immune Responses Following Three Doses2 , and the US lot consistency study3 (Study 3). In Study 3, subjects were randomly assigned to receive one of 3 lots of Prevnar 13 or Prevnar in a 2:2:2:1 ratio. The total number of infants vaccinated was 6632 (Study 2) and 16993 (Study 3). Immune responses to concomitant vaccine antigens were compared in infants receiving Prevnar and Prevnar 13. Responses to diphtheria toxoid, tetanus toxoid, pertussis, polio types 1, 2, and 3, hepatitis B, PRP-T, PRP-OMP, measles, and varicella antigens in Prevnar 13 recipients were similar to those in Prevnar recipients. Based on limited data, responses to mumps and rubella antigens in Prevnar 13 recipients were similar to those in Prevnar recipients.

Adults ≥50 Years of Age

Concomitant Administration with QIV

Prevnar 13 was administered to PPSV23 previously vaccinated adults ≥50 years of age concomitantly with a US-licensed inactivated influenza vaccine, quadrivalent (IIV4) (Fluzone Quadrivalent) for the 2014/2015 influenza season (Study 13) [see Adverse Reactions (6.2) and Drug Interactions (7.1)]. One study group received Prevnar 13 and IIV4 concurrently, followed approximately one month later by placebo. A second study group received IIV4 and placebo concurrently, followed approximately one month later by Prevnar 13.

Serotype-specific pneumococcal antibody responses were measured one month after Prevnar 13 vaccination as OPA GMTs. Noninferiority was demonstrated for each pneumococcal serotype if the lower limit of the 2-sided 95% CI for the GMT ratio (Prevnar 13 + IIV4 relative to Prevnar 13 alone) was >0.5. Although OPA antibody responses to Prevnar 13 generally appeared to be slightly lower when Prevnar 13 was administered concomitantly with IIV4 compared to Prevnar 13 administered alone, noninferiority was demonstrated for all Prevnar 13 pneumococcal serotypes evaluated in Study 13.

Strain-specific influenza antibody responses were measured one month after IIV4 as hemagglutinin inhibition assay (HAI) titers. HAI GMTs were evaluated for each IIV4 strain in Study 13. Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI for the HAI GMT ratio (Prevnar 13 + IIV4 relative to IIV4 + Placebo) was >0.5. Noninferiority was demonstrated for each IIV4 vaccine strain evaluated in Study 13.

Concomitant Administration with TIV

Two randomized, double-blind clinical trials evaluated the immunogenicity of Prevnar 13 given with IIV3 (Fall 2007/ Spring 2008 Fluarix, A/H1N1, A/H3N2, and B strains) in PPSV23 unvaccinated adults aged 50 through 59 years10 (Study 10, conducted in the US) and in adults ≥65 years11 (Study 11, conducted in Europe). Based on analysis of the primary pre-specified comparison of serotype specific anti-capsular polysaccharide IgG GMCs, noninferiority was met for all serotypes in adults 50–59 years of age and for 12 of 13 serotypes in adults ≥65years of age.

15 REFERENCES

ClinicalTrials.gov identifiers for studies included below:

  1. Study 1 NCT00205803
  2. Study 2 NCT00373958
  3. Study 3 NCT00444457
  4. Study 4 NCT00452452
  5. Study 5 NCT00761631
  6. Study 6 NCT00427895
  7. Study 7 NCT00546572
  8. Study 8 NCT00574548
  9. Study 9 NCT00500266
  10. Study 10 NCT00521586
  11. Study 11 NCT00492557
  12. Study 12 NCT00744263
  13. Study 13 NCT02124161

16 HOW SUPPLIED/STORAGE AND HANDLING

Prefilled Syringe, 1 Dose (10 per package) – NDC 0005-1971-02.

Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-1971-05.

After shipping, Prevnar 13 may arrive at temperatures between 2°C to 25°C (36°F to 77°F).

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

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

Prevnar 13 is stable at temperatures up to 25°C (77°F) for 4 days. These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions.

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

17 PATIENT COUNSELING INFORMATION

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

  • The potential benefits and risks of immunization with Prevnar 13 [see Warnings and Precautions (5) and Adverse Reactions (6)].
  • The importance of completing the immunization series unless contraindicated.
  • Any suspected adverse reactions should be reported to their 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).

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo
(click image for full-size original)

US Govt. License No. 3

LAB-0469-18.0
CPT Code 90670

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

NDC 0005-1971-01
Rx only

Pneumococcal 13-valent Conjugate
Vaccine
(Diphtheria CRM197 Protein)

Prevnar 13®

One Dose (0.5 mL)
FOR IM USE ONLY

REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Wyeth Pharm. LLCUS Govt. License No. 3

PAA133492

LOT:

EXP:

Principal Display Panel -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Syringe Carton

NDC 0005-1971-02
Rx only

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Prevnar 13®

10 One-Dose (0.5 mL)

Disposable Syringes

FOR INTRAMUSCULAR USE ONLY

Pfizer

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

PRINCIPAL DISPLAY PANEL — 1 Syringe Carton

NDC 0005-1971-05

Rx only

Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)

Prevnar 13®

One Dose (0.5 mL)Disposable Syringe

FOR INTRAMUSCULAR USE ONLY

Pfizer

PRINCIPAL DISPLAY PANEL -- 1 Syringe Carton
(click image for full-size original)
PREVNAR 13 pneumococcal 13-valent conjugate vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0005-1971
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 2.2 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 2.2 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 2.2 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 2.2 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 2.2 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 4.4 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 2.2 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 2.2 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 2.2 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 2.2 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 2.2 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 2.2 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 2.2 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN 34 ug in 0.5 mL
POLYSORBATE 80 100 ug in 0.5 mL
ALUMINUM PHOSPHATE 125 ug in 0.5 mL
SUCCINATE DIANION 295 ug in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0005-1971-02 10 SYRINGE in 1 CARTON contains a SYRINGE (0005-1971-01)
1 NDC:0005-1971-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-1971-02)
2 NDC:0005-1971-05 1 SYRINGE in 1 CARTON contains a SYRINGE (0005-1971-01)
2 NDC:0005-1971-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0005-1971-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125324 03/12/2010
Labeler — Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985586408 ANALYSIS (0005-1971), API MANUFACTURE (0005-1971), MANUFACTURE (0005-1971)
Establishment
Name Address ID/FEI Operations
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC 174350868 ANALYSIS (0005-1971)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceutical Division of Wyeth Holdings LLC 883534067 ANALYSIS (0005-1971), API MANUFACTURE (0005-1971)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceutical Division of Wyeth Holdings LLC 054065909 ANALYSIS (0005-1971), API MANUFACTURE (0005-1971)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 LABEL (0005-1971), PACK (0005-1971)

Revised: 10/2020 Wyeth Pharmaceutical Division of Wyeth Holdings LLC

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