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. Solicited local and systemic adverse reactions were recorded daily by parents/guardians using an electronic diary for 7 consecutive days following each vaccination. Please include at least one social/website link containing a recent photo of the actor. In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13 with Human Papillomavirus Vaccine (HPV), Meningococcal Conjugate Vaccine (MCV4) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap). *The need for revaccination with a subsequent dose of Prevnar 13 has not been established. Check with your doctor as soon as possible if any of the following side effects occur: Seek immediate medical attention if any of the following occur: Some people may experience side effects other than those listed. 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. The vaccine efficacy against AOM episodes due to vaccine-related serotypes (6A, 9N, 18B, 19A, 23A), also assessed in the Finnish trial, was 51% (95% CI: 27, 67) in the per-protocol population and 44% (95% CI: 20, 62) in the intent-to-treat population. In an open-label, single-arm, descriptive study, 3 doses of Prevnar 13 were administered 1 month apart to HIV-infected subjects ≥6 years of age with CD4 counts ≥200 cells/µL, and serum HIV RNA titer <50,000 copies/mL. Mild infections without fever, such as colds, usually do not require delay of the vaccine. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. The single antibody reference value was based on pooled efficacy estimates from three placebo-controlled IPD efficacy trials with either Prevnar or the investigational 9-valent CRM197 conjugate pneumococcal polysaccharide vaccine. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM Protein]) Suspension for Intramuscular InjectionDESCRIPTION. A second study group received IIV4 and placebo concurrently, followed approximately one month later by Prevnar 13. 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. There were 3 (0.063%) deaths among Prevnar 13 recipients, and 1 (0.036%) death in Prevnar recipients, all as a result of sudden infant death syndrome (SIDS). When Prevnar 13 is administered at the same time as another injectable vaccine(s), the vaccines should always be administered with different syringes and given at different injection sites. One death due to cardiac failure occurred 3 days after receiving placebo. 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). Last updated on Oct 1, 2020. Overall, 49.6% of subjects were male infants. In addition, the lower limit of the 95% confidence interval for the mcOPA antibody GMT ratio (Prevnar 13/PPSV23) was greater than 1 for 8 of the serotypes in common. The incidence and severity of solicited adverse reactions that occurred within 7 days following each dose of Prevnar 13 or Prevnar administered to US infants and toddlers are shown in Tables 3 and 4. Are there any other precautions or warnings for this medication? Pneumococcal Immune Responses Following Four Doses. Solicited Adverse Reactions in the Three US Infant and Toddler Studies. Higher serotype-specific mcOPA antibody GMT ratios [(Prevnar 13/PPSV23) / PPSV23] were generally observed compared to the one year dosing interval in Study 8. The NCKP trial also demonstrated a 20% reduction (95% CI: 2, 35) in the placement of tympanostomy tubes in the per-protocol population and a 21% reduction (95% CI: 4, 34) in the intent-to-treat population. The commonly reported local adverse reactions after Prevnar 13 vaccination in PPSV23 unvaccinated and PPSV23 previously vaccinated adults were redness, swelling and pain at the injection site, or limitation of arm movement (Tables 11 and 12). Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. The following adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Prevnar 13 vaccine. Individuals with altered immunocompetence, including those at higher risk for invasive pneumococcal disease (e.g., individuals with congenital or acquired splenic dysfunction, HIV infection, malignancy, hematopoietic stem cell transplant, nephrotic syndrome), may have reduced antibody responses to immunization with Prevnar 13 [see Use in Specific Populations (8.6)]. Bleeding problems: There is a risk of increased bleeding or bruising when any intramuscular injection is given to a person who has a bleeding disorder or is taking medications to thin the blood. Among 4,204 subjects who received at least 1 dose of Prevnar in clinical trials conducted globally, there were 3 hypotonic-hyporesponsive episode adverse reactions reported (0.071%). Patients should always ask their doctors for medical advice about adverse events. The importance of completing the immunization series unless contraindicated. In a developmental toxicity study, female rabbits were administered Prevnar 13 by intramuscular injection twice prior to mating (17 days and 3 days prior to mating) and twice during gestation (gestation days 10 and 24), 0.5 mL/rabbit/occasion (each dose approximately 20 times the human dose). Responses to the 7 common serotypes in Prevnar 13 and Prevnar recipients were compared directly. What side effects are possible with this medication? The vaccine efficacy against AOM episodes due to vaccine serotypes assessed in the Finnish trial, was 57% (95% CI: 44%, 67%) in the per-protocol population and 54% (95% CI: 41%, 64%) in the intent-to-treat population. 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. Are there any other precautions or warnings for this medication? 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. PREVNAR 13 ® should not be given to anyone with a severe allergic reaction to any component of PREVNAR 13 ® or any diphtheria toxoid–containing vaccine. 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)]. 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. 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)]. All subjects in this study were White and non-Hispanic. Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar recipients. The polysaccharides are chemically activated to make saccharides, which are directly conjugated by reductive amination to the protein carrier CRM197, to form the glycoconjugate. 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. For current full prescribing information, please visit www.pfizer.com. The OPA antibody assay provides an in vitro measurement of the ability of serum antibodies to eliminate pneumococci by promoting complement-mediated phagocytosis and is believed to reflect relevant in vivo mechanisms of protection against pneumococcal disease. Data from the NCKP trial accumulated through an extended follow-up period to April 20, 1999, in which a total of 37,866 children were included (18,925 in Prevnar group and 18,941 in MnCC control group), resulted in similar otitis media efficacy estimates for all endpoints. Individuals with the diseases or conditions listed below are at increased risk of pneumococcal disease. Children: This vaccine is not recommended for infants under 6 weeks old. Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM'197 Protein]) was licensed in the US for infants and children in 2000, following a randomized, double-blind clinical trial in a multiethnic population at Northern California Kaiser Permanente (NCKP) from October 1995 through August 20, 1998, in which 37,816 infants were randomized to receive either Prevnar or a control vaccine (an investigational meningococcal group C conjugate vaccine [MnCC]) at 2, 4, 6, and 12–15 months of age. PREVNAR 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) This product information is intended only for residents of the United States. Immune responses elicited by Prevnar 13 administered on a US schedule to preterm infants have not been studied. OPA antibody titers measured in the mcOPA antibody assay cannot be compared directly to titers measured in the dOPA antibody assay. 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. In the NCKP trial, in which the endpoint was all otitis media episodes regardless of etiology, vaccine efficacy was 7% (95% CI: 4%, 10%) and 6% (95% CI: 4%, 9%), respectively, in the per-protocol and intent-to-treat analyses. You may be at higher risk than you think from bacteria that can lead to pneumonia, bacteremia, and meningitis. Serotype-specific mcOPA antibody GMTs measured 1 month after each vaccination were calculated. 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. There were no vaccine-related fetal malformations or variations. 2. Serious Adverse Events in All Infant and Toddler Clinical Studies. - Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine - Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response - A. Across the 6 studies the racial distribution included: >85% White; 0.2%–10.7% Black or African American; 0%–1.7% Asian; <1% Native Hawaiian or other Pacific Islander; ≤1%, American Indian or Alaskan Native. The pneumococcal conjugate 13-valent (Pneu-C-13) vaccine, Prevnar®13, is authorized for use for the prevention of IPD; specifically for the active immunization against Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The vaccination schedule and concomitant vaccinations used in these infant trials were consistent with country-specific recommendations and local clinical practice. A serum anti-capsular polysaccharide antibody concentration of 0.35 µg/mL as measured by ELISA one month after the third dose as a single antibody reference concentration was used to estimate the effectiveness of Prevnar 13 against invasive pneumococcal disease (IPD) in infants and children. How should I use this medication? Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response. The effectiveness of Prevnar 13 in this specific population has not been established. In children 5 through 9 years of age, serotype-specific IgG concentrations measured 1 month after vaccination were noninferior (i.e., the lower limit of the 2-sided 95% CI for the geometric mean ratio [GMR] of >0.5) to the corresponding IgG concentrations in toddlers (Study 3) 1 month after a fourth pneumococcal vaccination (after the 4th dose of Prevnar for the 7 common serotypes and after the 4th dose of Prevnar 13 for the 6 additional serotypes) as shown in Tables 22 and 23 respectively. Unsolicited Adverse Reactions in the Three US Infant and Toddler Safety Studies. A post hoc analysis of the immune responses as measured by OPA antibody assay showed the pattern of functional antibody responses to be consistent with IgG responses for each serotype. Your doctor may have suggested this vaccine for conditions other than the ones listed in these drug information articles. Pneumococcal bacteria can infect the sinuses and inner ear. 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. These factors may affect how you should use this medication. The noninferiority criterion for pneumococcal anti-capsular polysaccharide GMCs after 4 doses was met for 12 of the 13 pneumococcal serotypes. A total of 84,496 subjects received either a single dose of Prevnar 13 (42,240) or placebo (42,256) in a 1:1 randomization. The median duration of follow-up per subject was 3.93 years. What other drugs could interact with this medication? The percentage of children 5 through 9 years of age who received 3 and 4 prior doses of Prevnar was 29.1% and 54.5% respectively. In the total safety population, more males (55.9%) were enrolled than females. In the safety population, 42.3% of subjects had pre-existing medical conditions including heart disease (25.4%), lung disease or asthma (15.1%) and type 1 and type 2 diabetes mellitus (12.5%). down the sink or in the toilet) or in household garbage. Statement on the recommended use of pneumococcal 23-valent polysaccharide vaccine in homeless persons and injection drug users. The total number of infants vaccinated was 6632 (Study 2) and 16993 (Study 3). Nonmedicinal ingredients: aluminum phosphate adjuvant, polysorbate 80, sodium chloride, succinic acid, and water for injection. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The vaccine should be kept in a refrigerator until it is ready to be used. All subjects had a history of stable engraftment (absolute neutrophil count>1000/µL, platelet count >50,000/µL), and did not have uncontrolled graft versus host disease. If you miss an appointment to receive the pneumococcal vaccine, contact your doctor as soon as possible to reschedule your appointment. The 48,806 Prevnar 13 recipients included 899 adults who were aged 18 through 49 years, 2,616 adults who were aged 50 through 64 years, 45,291 adults aged 65 years and older. These SIDS rates are consistent with published age specific background rates of SIDS from the year 2000. The data following one dose of Prevnar 13 in children 24 months through 59 months of age are shown in Table 21. A US study5 (Study 5) evaluated the use of Prevnar 13 in children previously immunized with Prevnar. Immune responses to concomitant vaccine antigens were compared in infants receiving Prevnar and Prevnar 13. For all vaccine serotypes anti-pneumococcal OPA GMTs were numerically higher after the first dose compared to pre-vaccination (N=197–257); OPA GMTs following the first, second and third dose were generally comparable. Medications other than those listed above may interact with this medication. Side effects can be mild or severe, temporary or permanent. (Diphtheria CRM197 Protein), Pneumococcal 13-valent Conjugate Vaccine The pneumococcal vaccine increases a person's defences against infection with pneumococcal bacteria by introducing very small amounts of bacterial components (not live bacteria) into the bloodstream. You know PREVNAR 13 ® can help protect you from 13 strains of bacteria that cause pneumococcal pneumonia. Strain-specific influenza antibody responses were measured one month after IIV4 as hemagglutinin inhibition assay (HAI) titers. Prevnar ® 13 is a pneumococcal vaccine that helps protect against 13 types of the bacteria Streptococcus pneumoniæ. Pregnancy: Studies of the effects of this vaccine during pregnancy have not been done. Do not mix Prevnar 13 with other vaccines/products in the same syringe. Children 15 Months Through 59 Months of Age Previously Vaccinated with Prevnar. Abbreviations: CAP = community-acquired pneumonia; CI = confidence interval; NB/NI = nonbacteremic/noninvasive; IPD = invasive pneumococcal disease; VE = vaccine efficacy; VT = vaccine-type. In the 6 safety and immunogenicity studies,6–11 subjects were excluded from study participation due to prior receipt of diphtheria toxoid-containing vaccines within 6 months of study vaccine. Pneumococcal Immune Responses Following Three Doses. Prevnar 13 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. Overall, 51.2% of subjects were male. The racial distribution was 98.5% White, 0.3% Black, 0.7% Asian, 0.5% Other, with <0.1% having missing data. The efficacy of Prevnar against otitis media was assessed in two clinical trials: a trial in Finnish infants at the National Public Health Institute and the efficacy trial in US infants at Northern California Kaiser Permanente (NCKP). Talk to your health care professional if you plan to get ZOSTAVAX ® (Zoster Vaccine Live) at the same time as PNEUMOVAX 23 because it may be better to get these vaccines at least 4 weeks apart. In 5 of the 6 safety and immunogenicity studies, more females than males were enrolled (50.2% – 61.8%). Immunization with the pneumcocccal vaccine requires 1 to 4 doses of the vaccine, depending on your age at the first dose. Medical conditions: Parents of children who were born prematurely or have problems with blood clotting or bleeding, a weakened immune system (due to conditions such as HIV, cancer, spleen problems, or medications that suppress the immune system such as those used for cancer, rheumatoid arthritis, or organ transplants) should discuss with their doctor how this vaccine may affect their child's medical condition, how their child's medical condition may affect the dosing and effectiveness of this vaccine, and whether any special monitoring is needed. The effectiveness of Prevnar 13 in this specific population has not been established. Study 7 was randomized and compared the safety and immunogenicity of Prevnar 13 with PPSV23 as a single dose in adults ≥70 years vaccinated with PPSV23 (≥5 years prior to enrollment).7 Study 8 was randomized and evaluated the safety and immunogenicity of Prevnar 13 and PPSV23 in different sequential order in PPSV23 naive adults aged 60 through 64 years8. In addition, the lower limit of the 95% confidence interval for the mcOPA antibody GMT ratio (Prevnar 13/PPSV23) was greater than 1 for 9 of the serotypes in common. A statistically significantly greater response for Prevnar 13 was defined, for the difference in percentages (Prevnar 13 minus PPSV23) of adults achieving a ≥4-fold increase in anti-6A mcOPA antibody titer, as the lower limit of the 2-sided 95% CI greater than zero. The mcOPA antibody GMTs elicited by Prevnar 13 in adults aged 50 through 59 years were noninferior to the corresponding mcOPA antibody GMTs elicited by Prevnar 13 in adults aged 60 through 64 years for all 13 serotypes (see Table 25). Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12-15 months of age. A one-time dose of PREVNAR 13 ® for adults can help protect you from pneumococcal pneumonia—it is not a yearly shot. Your pharmacist may be able to advise you on managing side effects. These data do not provide evidence for a causal relationship between deaths and vaccination with Prevnar 13. Table 1: Vaccination Schedule for Infants and Toddlers Dose a,bDose 1 cDose 2 b Dose 3 b 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). Serotype-specific pneumococcal antibody responses were measured one month after Prevnar 13 vaccination as OPA GMTs. 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. Prevnar 13 is stable at temperatures up to 25°C (77°F) for 4 days. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. There are no data on the concomitant administration of Prevnar 13 with diphtheria toxoid-containing vaccines and other vaccines licensed for use in adults 50 years of age and older. Based on limited data, responses to mumps and rubella antigens in Prevnar 13 recipients were similar to those in Prevnar recipients. In infants that have received Prevnar 13, opsonophagocytic activity correlates well with serotype specific anti-capsular polysaccharide IgG levels as measured by ELISA. Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 13. Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. 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). 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 … Most subjects were White (77.3%), 14.2% were Black or African-American, and 1.7% were Asian; 79.1% of subjects were non-Hispanic and non-Latino and 14.6% were Hispanic or Latino. Data accumulated through an extended follow-up period to April 20, 1999, resulted in similar efficacy estimates of 97.4% in the per-protocol analysis and 93.9% in the intent-to-treat analysis (95% CI: 82.7%, 99.9% and 79.6%, 98.5%, respectively). In addition, after each subsequent dose of Prevnar 13, IgG GMCs for all serotypes were numerically higher than responses after the previous dose. Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age. For all vaccine serotypes, anti-pneumococcal opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) were higher after the first dose compared to pre-vaccination (N=95–131); OPA GMTs following the first and second dose were comparable. (Diphtheria CRM197 Protein), Prevnar, Pneumovax 23, pneumococcal 13-valent vaccine. Adults with weakened immune systems (eg HIV infection, leukemia) may have a reduced immune response. The incidence rates of any fever (≥38.0°C) were similar on days 1 and 2 following each dose of Prevnar 13 compared to after each dose of Prevnar administered to US infants and toddlers (day 1 = day of vaccination). Serious adverse events were also collected throughout the study period. 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. Sera were obtained approximately one month after each vaccination. In adults aged 60 through 64 years, the mcOPA antibody GMTs elicited by Prevnar 13 were noninferior to those elicited by PPSV23 for the 12 serotypes in common to both vaccines (see Table 24). Streptococcus pneumoniae Immunization. From 1 month to 6 months after an initial study dose, serious adverse events were reported in 0.2%–5.8% of subjects vaccinated during the studies with Prevnar 13 and in 2.4%–5.5% of subjects vaccinated with PPSV23. In five studies,6–8,10,11 subjects with pre-existing underlying diseases were enrolled if the medical condition was stable (did not require a change in therapy or hospitalization for worsening disease for 12 weeks before receipt of study vaccine) except in Study 9 where subjects were enrolled if the medical condition was stable for 6 or more weeks before receipt of study vaccine. Also in Study 8, 266 subjects received Prevnar 13 followed by PPSV23 one year later (Prevnar 13/PPSV23). 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. A developmental toxicity study has been performed in female rabbits administered Prevnar 13 prior to mating and during gestation. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. These bacteria can cause serious infections like pneumonia, meningitis, and blood infections.This vaccine will lower your chance of getting pneumonia.If you do get pneumonia, it can make your symptoms milder and your illness shorter.This vaccine will not treat an infection and will not cause infection.
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