When preterm infants (<37 weeks gestational age, N=100) were administered 4 doses of Prevnar 13 on a non-US schedule, the serotype-specific IgG antibody responses after the third and fourth dose were lower compared to responses among term infants (≥37 weeks gestational age, N=100) for some serotypes; the effectiveness of Prevnar 13 in preterm infants cannot be established from this study. *The need for revaccination with a subsequent dose of Prevnar 13 has not been established. Administration site conditions: Vaccination-site dermatitis, vaccination-site pruritus, vaccination-site urticaria, Blood and lymphatic system disorders: Lymphadenopathy localized to the region of the injection site, Immune system disorders: Anaphylactic/anaphylactoid reaction including shock, Skin and subcutaneous tissue disorders: Angioneurotic edema, erythema multiforme. Adults 18 through 59 years of age received a single dose of Prevnar 13, and adults 60 through 64 years of age received a single dose of Prevnar 13 or PPSV23. This product's label may have been updated. 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). Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Talk to your doctor about whether you should continue breast-feeding. Unsolicited serious and non-serious adverse events were collected for one month after each vaccination. Upon receipt, store refrigerated at 2°C to 8°C (36°F to 46°F). 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. In adults, Prevnar 13 was administered concomitantly with US-licensed inactivated influenza vaccines, trivalent and quadrivalent (Studies 10, 11 and 13)[see Clinical Studies (14.4) and Adverse Reactions (6.2)]. In a study in rabbits, no vaccine-related effects were found regarding reproductive performance including female fertility [see Use in Specific Populations (8.1)]. Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine [see Description (11)]. Rodriguez R. Safety of pneumococcal revaccination. If you have these conditions, discuss the risks and benefits of this vaccine with your doctor. Serious adverse events were collected throughout the study period for all 13 clinical trials. Unsolicited Adverse Reactions in the Three US Infant and Toddler Safety Studies. There were 10 deaths (<0.1%) in the Prevnar 13 group and 10 deaths (<0.1%) in the placebo group within 28 days of vaccination. In the subset of subjects where serious adverse events were monitored for 6 months, 70 of 1,006 (7%) Prevnar 13 vaccinated subjects (90 events) and 60 of 1,005 (6%) placebo vaccinated subjects (69 events) reported serious adverse events. Patients should always ask their doctors for medical advice about adverse events. Immune responses elicited by Prevnar 13 administered on a US schedule to preterm infants have not been studied. Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established. 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). Serum IgG concentrations were measured one month after the final dose in each age group and the data are shown in Table 20. This website is intended for US citizens as it provides US content; if you wish to continue, click on the United States flag below. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN, ANALYSIS(0005-1971), API MANUFACTURE(0005-1971), MANUFACTURE(0005-1971), Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, ANALYSIS(0005-1971), API MANUFACTURE(0005-1971), active immunization for the prevention of invasive disease caused by, active immunization for the prevention of otitis media caused by, active immunization for the prevention of pneumonia and invasive disease caused by, Prevnar 13 does not protect against disease caused by, The potential benefits and risks of immunization with Prevnar 13. The reported causes of the 10 remaining deaths occurring greater than 30 days after receiving Prevnar 13 were cardiac disorders (4), neoplasms (4), Mycobacterium avium complex pulmonary infection (1) and septic shock (1). Keep it out of the reach of children. www.medbroadcast.com/drug/getdrug/Prevnar-13, reaction at place of injection such as a hard lump, pain, redness, soreness, swelling, apnea (longer gaps between breaths) in premature babies, signs of an allergic reaction (e.g., difficulty breathing or swallowing; hives; itching, especially of feet or hands; reddening of skin, especially around the ears; swelling of eyes, face, or inside of nose; unusual tiredness or weakness [sudden or severe]), corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone), medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine). It is used to prevent pneumonia (lung infection), meningitis (brain lining infection), pleural empyema (pus buildup in the space between the lung and the chest wall), bacteraemia (bacterial blood infection), and sepsis (a life-threatening infection causing rapid breathing and heart rate, organ shutdown, and dangerously low blood pressure) caused by various types of pneumococcal bacteria. Several other otitis media endpoints were also assessed in the two trials. The safety of Prevnar 13 was assessed in 7 clinical studies (Studies 6–12) 6–12 conducted in the US and Europe which included 91,593 adults (48,806 received Prevnar 13) ranging in age from 18 through 101 years. Based on limited data, responses to mumps and rubella antigens in Prevnar 13 recipients were similar to those in Prevnar recipients. The efficacy of Prevnar 13 against vaccine-type (VT) pneumococcal community-acquired pneumonia (CAP) and IPD was assessed in a randomized, double-blind, placebo-controlled study conducted over ~ 4 years in the Netherlands12 (Study 12). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. For example, bacteremia, a blood infection with or without pneumonia, and meningitis, an infection of the lining that covers the brain, are 2 serious infections caused by … Vaccine In children 24 months through 5 years of age, lower antibody concentrations were observed for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months). In this study, conducted between December 1995 and March 1999, parents of study participants were asked to bring their children to the study clinics if the child had respiratory infections or symptoms suggesting acute otitis media (AOM). The incidence and severity of solicited adverse reactions that occurred within 4 days following each dose of Prevnar 13 administered to pneumococcal-vaccine naïve children 7 months through 5 years of age are shown in Tables 5 and 6. 3. 100 % din cazurile de boală invazivă la copiii cu vârsta sub cinci ani și cel puțin 50 până la 76 % din cazurile de boală invazivă la adulți, în funcție de țară. Most subjects were White (74.3%), 14.9% were Black or African-American, and 1.2% were Asian; 89.3% of subjects were non-Hispanic and non-Latino and 10.7% were Hispanic or Latino. Serotype-specific pneumococcal antibody responses were measured one month after Prevnar 13 vaccination as OPA GMTs. Also in Study 8, 266 subjects received Prevnar 13 followed by PPSV23 one year later (Prevnar 13/PPSV23). The assay used for this determination is a standardized ELISA involving pre-absorption of the test sera with pneumococcal C-polysaccharide and serotype 22F polysaccharide to reduce non-specific background reactivity. Three studies in the US (Studies 1, 2 and 3)1,2,3 evaluated the safety of Prevnar 13 when administered concomitantly with routine US pediatric vaccinations at 2, 4, 6, and 12–15 months of age. These studies were designed to evaluate immunologic noninferiority of Prevnar 13 to Prevnar. Pneumococcal vaccine should not be used by anyone who is allergic to pneumococcal vaccine or to any of the ingredients of the vaccine, including diphtheria toxoid. Immune responses to Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine were compared in a head to head trial in adults aged ≥ 70 years, who had received a single dose of pneumococcal polysaccharide vaccine at least 5 years before study vaccination. Among the 84,496 subjects, 58,072 (68.7%) were ≥65 to <75 years of age, 23,481 (27.8%) were ≥75 and <85 years of age, and 2,943 (3.5%) were ≥85 years of age. Side effects can be mild or severe, temporary or permanent. One case of erythema multiforme occurred 34 days after receipt of a second dose of Prevnar 13. CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium or in a chemically-defined medium. How does this medication work? You know PREVNAR 13 ® can help protect you from 13 strains of bacteria that cause pneumococcal pneumonia. The study also compared immune responses of PPSV23 as a single dose to the responses to PPSV23 administered one year after a dose of Prevnar 13. Available for Android and iOS devices. Add all vaccines you receive to your immunization record. What will it do for me? Prior receipt of PPSV23 within 1 year results in diminished immune responses to Prevnar 13 compared to PPSV23 naïve individuals [see Clinical Studies (14.3)]. Of the 6 Phase 3 or Phase 4 clinical trials, 2 noninferiority trials6,7 were conducted in which the immune responses to Prevnar 13 were compared with the immune responses to PPSV23; one in PPSV23 unvaccinated adults aged 18 through 64 years6 (Study 6), and one in PPSV23 previously vaccinated adults aged ≥70 years7 (Study 7). In addition, serious adverse events were collected for an additional 5 months after each vaccination (at the 6-month follow-up phone contact) in all studies except Study 11. Six Phase 3 or Phase 4 clinical trials6–8,10,11,13 were conducted in the US and Europe evaluating the immunogenicity of Prevnar 13 in different adult age groups, in individuals who were either not previously vaccinated with PPSV23 (PPSV23 unvaccinated) or who had received one dose of PPSV23 (PPSV23 previously vaccinated). A third study compared immune responses to a single dose of Prevnar 13 to the response to Prevnar 13 administered one year after a dose of PPSV23 in adults aged 60 through 64 years who were PPSV23 unvaccinated at enrollment8 (Study 8). Each serotype is grown in soy peptone broth. Overall across the clinical studies evaluating the immunogenicity of Prevnar 13 in adults, persons 18 through 64 years of age responded at least as well as persons 65 years and older, the age group evaluated in a clinical endpoint efficacy trial. The data following one dose of Prevnar 13 in children 24 months through 59 months of age are shown in Table 21. A second study group received IIV4 and placebo concurrently, followed approximately one month later by Prevnar 13. The incidence and severity of solicited adverse reactions that occurred within 7 or 14 days following each dose of Prevnar 13, PPSV23, or placebo administered to adults in 5 studies are shown in Tables 11, 12, 13, and 14. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. In adults aged 18 through 49 years, the mcOPA antibody GMTs elicited by Prevnar 13 were noninferior to those elicited by Prevnar 13 in adults aged 60 through 64 years for all 13 serotypes (see Table 25). In an open-label descriptive study in the US5 (Study 5), children 15 months through 59 months previously vaccinated with 3 or 4 doses of Prevnar, received 2 doses of Prevnar 13 (children >15 through 23 months of age) or 1 dose of Prevnar 13 (children 24 months through 59 months of age). Speak to your doctor about how any drug interactions are being managed or should be managed. A one-time dose of PREVNAR 13 ® for adults can help protect you from pneumococcal pneumonia—it is not a yearly shot. Information regarding unsolicited and serious adverse events, newly diagnosed chronic medical conditions, and hospitalizations since the last visit were collected during the clinic visit for the fourth-study dose and during a scripted telephone interview 6 months after the fourth-study dose. The exceptions were serotypes 6B, 9V, and 3. In Study 2, post-dose 4 antibody concentrations were higher for all 13 serotypes than those achieved after the third dose. Previously Unvaccinated Older Infants and Children 7 Months Through 5 Years of Age. Prevnar 13 ® will only help protect against S. pneumoniae serotypes in the vaccine. Among 6,839 subjects who received at least 1 dose of Prevnar 13 in clinical trials conducted globally, there was 1 hypotonic-hyporesponsive episode adverse reaction reported (0.015%). The vaccine should be kept in a refrigerator until it is ready to be used. If you become pregnant while using this medication, contact your doctor immediately. In infants that have received Prevnar 13, opsonophagocytic activity correlates well with serotype specific anti-capsular polysaccharide IgG levels as measured by ELISA. One study (Study 13) assessed the concomitant administration of Prevnar 13 with seasonal inactivated Fluzone Quadrivalent (IIV4) in PPSV23 previously vaccinated adults ≥50 years of age in the US. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. Pneumococcal 13-valent vaccine works by exposing you to a small amount of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. In a Phase 3 active-controlled, modified double-blind clinical trial7 (Study 7) of Prevnar 13 in the US and Sweden, PPSV23 previously vaccinated adults aged ≥70 years who had received one dose of PPSV23 ≥5 years prior were randomly assigned (1:1) to receive either Prevnar 13 or PPSV23. The side effects listed below are not experienced by everyone who takes this vaccine. OPA antibody titers measured in the mcOPA antibody assay cannot be compared directly to titers measured in the dOPA antibody assay. Across the 6 safety and immunogenicity studies,6–11 serious adverse events within 1 month of vaccination were reported after an initial study dose in 0.2%–1.4% of 5,057 subjects vaccinated with Prevnar 13, and in 0.4%–1.7% of 1,124 subjects vaccinated after an initial study dose of PPSV23. 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. In an open-label, single-arm, descriptive study, 4 doses of Prevnar 13 were administered to subjects ≥2 years of age (range 2 to 71 years) who had received an allogeneic hematopoietic stem cell transplant 3 to 6 months prior to enrollment. Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar recipients. Can Commun Dis Rep. 2008;34(ACS-5):1-12. The incidence and severity of solicited adverse reactions that occurred within 7 days following one dose of Prevnar 13 administered to children 15 months through 59 months of age are shown in Tables 7 and 8. Terms and conditions of use. Prevnar ® 13 is a pneumococcal vaccine that helps protect against 13 types of the bacteria Streptococcus pneumoniæ. In Study 6, which was conducted in PPSV23-unvaccinated adults 60 through 64 years of age, 108 subjects received PPSV23 3.5 to 4 years after Prevnar 13 (Prevnar 13/PPSV23) and 414 received a single dose of PPSV23. Clinical Trials Conducted in PPSV23 Unvaccinated Adults. How does this medication work? Any suspected adverse reactions should be reported to their healthcare professional. This vaccine should not be used during pregnancy unless the benefits outweigh the risks. In clinical trials with infants and toddlers, Prevnar 13 was administered concomitantly with the following US-licensed vaccines: Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] (DTaP-HBV-IPV) and ActHIB [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] (PRP-T) for the first three doses and with PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] (PRP-OMP), M-M-R II [Measles, Mumps, Rubella Virus Vaccine Live] (MMR) and Varivax [Varicella Virus Vaccine Live], or ProQuad [Measles, Mumps, Rubella and Varicella Virus Vaccine Live] (MMRV) and VAQTA [Hepatitis A vaccine, Inactivated] (HepA) for dose 4 [see Clinical Studies (14.2) and Adverse Reactions (6.1)]. Source: www.medbroadcast.com/drug/getdrug/Prevnar-13, 02335204 Prevnar 13 Suspension (intramuscular), Eczema : Prescription Medication Options Table. 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. In Study 2, the noninferiority criterion for the proportion of subjects with pneumococcal anti-capsular polysaccharide IgG antibody concentrations ≥0.35 μg/mL one month after the third dose was met for 10 of the 13 serotypes. Prevnar 13: This medication belongs to a group of medications known as vaccines. What other drugs could interact with this medication? For the 12 serotypes in common to both vaccines, noninferiority between vaccines was met if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (Prevnar 13/PPSV23) was greater than 0.5. The median duration of follow-up per subject was 3.93 years. Adults 18Years and Older Safety was assessed in 7 clinical studies including 91,593 adults ranging in ages from 18 to 101 years. For unsolicited adverse events, study subjects were monitored from administration of the first dose until one month after the infant series, and for one month after the administration of the toddler dose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. Physician Prescribing Information ; What other drugs could interact with this medication? Note – ClinicalTrials.gov NCT number is as follows: NCT00452452 (Poland). Sera were obtained approximately one month after each vaccination. The assay used for this determination was a standardized ELISA involving pre-absorption of the test sera with pneumococcal C-polysaccharide and serotype 22F polysaccharide to reduce non-specific background reactivity.
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