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.
ClinicalTrials.gov identifiers for studies included below:
- Study 1 NCT00205803
- Study 2 NCT00373958
- Study 3 NCT00444457
- Study 4 NCT00452452
- Study 5 NCT00761631
- Study 6 NCT00427895
- Study 7 NCT00546572
- Study 8 NCT00574548
- Study 9 NCT00500266
- Study 10 NCT00521586
- Study 11 NCT00492557
- Study 12 NCT00744263
- Study 13 NCT02124161
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.
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.
US Govt. License No. 3
CPT Code 90670
PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label
Pneumococcal 13-valent Conjugate
(Diphtheria CRM197 Protein)
One Dose (0.5 mL)
FOR IM USE ONLY
DO NOT FREEZE
Wyeth Pharm. LLCUS Govt. License No. 3
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
10 One-Dose (0.5 mL)
FOR INTRAMUSCULAR USE ONLY
Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)
One Dose (0.5 mL)Disposable Syringe
FOR INTRAMUSCULAR USE ONLY
|PREVNAR 13 pneumococcal 13-valent conjugate vaccine injection, suspension|
|Labeler — Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)|
|Pfizer Ireland Pharmaceuticals||985586408||ANALYSIS (0005-1971), MANUFACTURE (0005-1971), API MANUFACTURE (0005-1971)|
|Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC||174350868||ANALYSIS (0005-1971)|
|Wyeth Pharmaceutical Division of Wyeth Holdings LLC||883534067||ANALYSIS (0005-1971), API MANUFACTURE (0005-1971)|
|Wyeth Pharmaceutical Division of Wyeth Holdings LLC||054065909||ANALYSIS (0005-1971), API MANUFACTURE (0005-1971)|
|Pfizer Manufacturing Belgium NV||370156507||ANALYSIS (0005-1971), MANUFACTURE (0005-1971), PACK (0005-1971), LABEL (0005-1971)|
Revised: 03/2021 Wyeth Pharmaceutical Division of Wyeth Holdings LLC
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