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This statement will supplement previous conjugate pneumococcal statements Footnote from 1-to Footnote 3 and provide information regarding a newly authorized indication for the use of the 13-valent conjugate vaccine against pneumococcal disease, Prevnar®13 (PNEU-C-13): As of January 2012, PNEU-C-13 has been authorized for use in adults aged 50 years … Each serotype is grown in soy peptone broth. Serious adverse events were collected throughout the study period for all 13 clinical trials. Do not dispose of medications in wastewater (e.g. Pneumococcal disease is a serious infection caused by a bacteria. Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your health than receiving Prevnar 13. Noninferiority trials for Prevnar 13 were designed to show that functional OPA antibody responses (as measured by a microcolony OPA [mcOPA] antibody assay) for the Prevnar 13 serotypes are noninferior and for some serotypes superior to the common serotypes in the currently licensed pneumococcal polysaccharide vaccine (PPSV23). Following licensure of Prevnar 13 in adults ≥50 years of age, a randomized, double-blind, placebo-controlled US study (Study 13) was conducted to evaluate concomitant administration of Prevnar 13 with inactivated influenza vaccine, quadrivalent (Fluzone® Quadrivalent, A/H1N1, A/H3N2, B/Brisbane, and B/Massachusetts, Fall 2014/Spring 2015: IIV4) in PPSV23 previously vaccinated adults ≥50 years of age. The following side effects have been reported by at least 1% of people taking this medication. Adults with pre-existing medical conditions, as well as subjects with a history of smoking were eligible for enrollment. Adults 18Years and Older Safety was assessed in 7 clinical studies including 91,593 adults ranging in ages from 18 to 101 years. Immune responses elicited by Prevnar 13 and PPSV23 were measured by a mcOPA antibody assay for the 13 pneumococcal serotypes contained in Prevnar 13. Deaths occurred between Day 3 and Day 309 after study vaccination with Prevnar 13 or PPSV23. If you have not discussed this with your doctor or are not sure why you are receiving this vaccine, speak to your doctor. Reactions occurring in greater than 1% of infants and toddlers: diarrhea, vomiting, and rash. 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. Submissions without photos may not be accepted. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. There were no vaccine-related fetal malformations or variations. However, vaccination with Prevnar reduced pneumococcal otitis media episodes overall. Children 15 months through 23 months of age (group 1) received 2 doses, and children 24 months through 59 months of age (group 2) received one dose. For a subset of 2,011 subjects (1,006 Prevnar 13 recipients and 1,005 placebo recipients), solicited adverse reactions were monitored by recording local and systemic events using electronic diaries for 7 days after vaccination; unsolicited adverse events were collected for 28 days after vaccination, and serious adverse events were collected for 6 months after vaccination. During the follow-up period (average of 4 years) for case accumulation there were 3,006 deaths (7.1%) in the Prevnar 13 group and 3,005 deaths (7.1%) in the placebo group. Adults with weakened immune systems (eg HIV infection, leukemia) may have a reduced immune response. Immunization with the pneumcocccal vaccine requires 1 to 4 doses of the vaccine, depending on your age at the first dose. Product Monograph – Prevnar® 13. 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). Prevenar 13 este foarte asemănător cu Prevenar, însă conține șase polizaharide suplimentare din serotipurile care cauzează 16 % până la 60 % din … Overall, 49.6% of subjects were male infants. Responses to the 7 common serotypes in Prevnar 13 and Prevnar recipients were compared directly. Physician Prescribing Information ; Compare Prevnar 13 prices at pharmacies near you. There were no substantive differences in demographic characteristics between the vaccine groups. 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. For serotype 6A, which is unique to Prevnar 13, the proportion of subjects with a ≥4-fold increase in mcOPA antibody titers after Prevnar 13 (71.1%) was statistically significantly greater than after PPSV23 (27.3%) in PPSV23 previously vaccinated adults aged ≥70 years. The exceptions were serotypes 6B, 9V, and 3. 7. Safety and immunogenicity of Prevnar 13 is supported by 6 clinical studies. Serious Adverse Events in Adult Clinical Studies. Following immunization with the Pneu-C-13 vaccine (Prevnar ® 13), high risk adults aged 50 years and older who meet any of the criteria listed above, should also receive pneumococcal polysaccharide 23-valent (Pneu-P-23) vaccine, or Pneumovax ® 23. These SIDS rates are consistent with published age specific background rates of SIDS from the year 2000. There may be an interaction between pneumococcal vaccine and any of the following: If you or your child is taking any of these medications, speak with your doctor or pharmacist. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 µg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides, 4.4 μg of 6B saccharides, 34 µg CRM197 carrier protein, 100 µg polysorbate 80, 295 µg succinate buffer and 125 µg aluminum as aluminum phosphate adjuvant. A total of 1,907 subjects received at least 1 dose of Prevnar 13 and 701 subjects received at least 1 dose of Prevnar in the three US studies (Studies 1, 2 and 3)1,2,3. 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. 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). 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. Note – ClinicalTrials.gov NCT number is as follows: NCT00452452 (Poland). Following the fourth dose, the functional dOPA antibody response for each serotype was quantitatively greater than the response following the third dose (see Table 19). By race, 84.0% of subjects were White, 6.0% were Black or African-American, 5.8% were Asian and 3.8% were of 'Other' race (most of these being biracial). Any suspected adverse reactions should be reported to their healthcare professional. In an active-controlled modified1 double-blind clinical trial6 (Study 6) of Prevnar 13 in the US, PPSV23 unvaccinated adults aged 60 through 64 years were randomly assigned (1:1) to receive Prevnar 13 or PPSV23. Can Commun Dis Rep. 2008;34(ACS-5):1-12. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 23 Oct 2020) and others. The effectiveness of Prevnar 13 in this specific population has not been established. 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)]. Pneumococcal vaccine 13-valent (PCV13) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F 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)]. Contact your doctor if you experience these side effects and they are severe or bothersome. The following adverse events have been reported through passive surveillance since market introduction of Prevnar 13. This medication is not intended for children under 6 weeks old. 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. How should I use this medication? The safety and effectiveness of this vaccine have not been established for people with thrombocytopenia (low platelets) or bleeding disorders. J Gen Intern Med. Adults with immunocompromising conditions or receiving immunosuppressive therapy and adults residing in a long-term care facility or requiring semiskilled nursing care were excluded. ©2020 Rexall Pharmacy Group Ltd. 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. Keep it out of the reach of children. Do not use the vaccine if it cannot be resuspended. Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following: 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). Streptococcus pneumoniae Immunization. Prevnar 13 helps your body make its own antibodies to help protect you against 13 types of the bacteria Streptococcus pneumoniae. OPA antibody titers are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. In children from 6 weeks to 5 years of age, it helps protect against diseases such as bacteraemic pneumonia (lung infection with bacteria in the blood stream), sepsis or bacteraemia … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. October 2010. Patients should always ask their doctors for medical advice about adverse events. The vaccine will be injected into a muscle (preferably in the thigh or upper, outer arm) by a qualified health professional. There are important differences between the two pneumococcal vaccines for adults available in Canada. Discard if the vaccine has been frozen. Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. The response to the additional serotype 6A, which is contained in Prevnar 13 but not in PPSV23, was assessed by demonstration of a ≥4-fold increase in the anti-6A mcOPA antibody titer above preimmunization levels. 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). Prevnar 13 ® will only help protect against S. pneumoniae serotypes in the vaccine. 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). 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. Clinical Trials Conducted in PPSV23 Previously Vaccinated Adults. Many of these side effects can be managed, and some may go away on their own over time. 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. Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]) is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). What will it do for me? Pneumococcal bacteria can infect the sinuses and inner ear. If you miss an appointment to receive the pneumococcal vaccine, contact your doctor as soon as possible to reschedule your appointment. What side effects are possible with this medication? Serious Adverse Events in All Infant and Toddler Clinical Studies. A side effect is an unwanted response to a medication when it is taken in normal doses. Serious adverse events observed during different study periods for Prevnar 13 and Prevnar respectively were: 1) 3.7% and 3.5% from dose 1 to the blood draw approximately 1 month after the infant series; 2) 3.6% and 2.7% from the blood draw after the infant series to the toddler dose; 3) 0.9% and 0.8% from the toddler dose to the blood draw approximately 1 month after the toddler dose and 4) 2.5% and 2.8% during the 6 month follow-up period after the last dose. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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. pneumococcal 13-valent conjugate vaccine injection, suspension, We comply with the HONcode standard for trustworthy health information -, 24 months through 5 years of age (prior to the 6. Dosage Form: injection, suspension. The racial distribution was 98.5% White, 0.3% Black, 0.7% Asian, 0.5% Other, with <0.1% having missing data. What other drugs could interact with this medication? After dose 3, fever was reported in 8.0–9.6% on day 1 and 9.1–10.5% on day 2. This vaccine should not be used during pregnancy unless the benefits outweigh the risks. Similarly, in exploratory analyses in PPSV23 previously vaccinated adults ≥70 years of age in Study 7, diminished mcOPA antibody GMTs were observed in those that received Prevnar 13 one year after PPSV23 when compared to those who received Prevnar 13 alone. Source: www.medbroadcast.com/drug/getdrug/Prevnar-13, 02335204     Prevnar 13 Suspension (intramuscular), Eczema : Prescription Medication Options Table. 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. Safety Results from Adult Clinical Study of Concomitant Administration of Prevnar 13 and IIV4 (Fluzone Quadrivalent) (Study 13). (Diphtheria CRM197 Protein), Pneumococcal 13-valent Conjugate Vaccine 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). Your pharmacist may be able to advise you on managing side effects. These studies were designed to evaluate immunologic noninferiority of Prevnar 13 to Prevnar. 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. 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. Children with a prior history of pneumococcal conjugate vaccination were excluded. Terms and conditions of use. The total number of infants vaccinated was 6632 (Study 2) and 16993 (Study 3). In a US study5 (Study 5), a single dose of Prevnar 13 was administered to children 5 through 9 years of age, who were previously vaccinated with at least one dose of Prevnar, and to pneumococcal vaccine-naïve children 10 through 17 years of age. Study 1212 was a randomized double-blind placebo-controlled study conducted in the Netherlands in community-dwelling adults aged 65 years and older with no prior pneumococcal vaccination history. 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. Clinical trials have been conducted in the US using a 2, 4, 6, and 12–15 month schedule. Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it. The incidence and severity of solicited adverse reactions that occurred within 7 days following one dose of Prevnar 13 administered to children 5 through 17 years of age are shown in Tables 9 and 10. If AOM was diagnosed, tympanocentesis was performed, and the middle-ear fluid was cultured. Prevnar 13 is for use in children from 6 weeks to 5 years old, and in adults who are 50 and older. In an open-label, single-arm, descriptive study, 2 doses of Prevnar 13 were administered 6 months apart to children ≥6 to <18 years of age with sickle cell disease who previously received PPSV23 at least 6 months prior to enrollment. If S. pneumoniae was isolated, serotyping was performed; the primary endpoint was efficacy against AOM episodes caused by vaccine serotypes in the per-protocol population. Safety data for the first three doses are available for all 13 infant studies; dose 4 data are available for 10 studies; and data for the 6-month follow-up are available for 7 studies. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response. Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age. Immune responses to concomitant vaccine antigens were compared in infants receiving Prevnar and Prevnar 13. In addition, after each subsequent dose of Prevnar 13, IgG GMCs for all serotypes were numerically higher than responses after the previous dose. Update: Pfizer Receives FDA Approval for Prevnar 13 in Adults Age 18 Through 49 July 12, 2016. The mcOPA antibody GMTs elicited by Prevnar 13 were noninferior to those elicited by PPSV23 for the 12 serotypes in common, when Prevnar 13 or PPSV23 were administered at a minimum of 5 years after a prior dose of PPSV23. This product should not be used if particulate matter or discoloration is found. Serotype-specific mcOPA antibody GMTs measured 1 month after each vaccination were calculated. What side effects are possible 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 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. Pneumococcal conjugate vaccine (PCV) is a pneumococcal vaccine and a conjugate vaccine used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). 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. 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. - 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. The vaccine is designed to prevent infection caused by the most common types of pneumonia-causing bacteria. 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. 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 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. Talk to your doctor about whether you should continue breast-feeding. A total of 84,496 subjects 65 years and older received a single dose of either Prevnar 13 or placebo in a 1:1 randomization; 42,240 subjects were vaccinated with Prevnar 13 and 42,256 subjects were vaccinated with placebo. This subject had received Prevnar 13 and IIV3 one month earlier. The vaccine should be kept in a refrigerator until it is ready to be used. Prevnar 13™ is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.Prevnar 13 is also indicated for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F… And after dose 4, fever was reported in 6.3–6.4% on day 1 and 7.3–9.7% on day 2. In this open label trial, 596 healthy children 15 through 59 months of age previously vaccinated with at least 3 doses of Prevnar, received 1 or 2 doses of Prevnar 13. Are there any other precautions or warnings for this medication? 5. Medically reviewed by Drugs.com. 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. 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. The data show that 3 doses of acetaminophen (the first dose administered at the time of each vaccination and the subsequent doses at 6 to 8 hour intervals) reduced the antibody response to some serotypes following the third dose of Prevnar 13, compared with responses among infants who received antipyretics only as needed for treatment. 4. Who should NOT take this medication? Overall, 53.6% of subjects were male infants. Ethnicity data were not collected in Study 11; in the 5 other studies 0.6%–4.8% were Hispanic or Latino. Print coupons for the best price on Prevnar 13 using the free WebMDRx Savings Card. 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. Strain-specific influenza antibody responses were measured one month after IIV4 as hemagglutinin inhibition assay (HAI) titers. These factors may affect how you should use this medication. 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%). 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. Overall, 52.2% of subjects were male. 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)]. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. Also tell them about any supplements you or your child takes. 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), bacteremia (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. 6. In Study 1212 (subjects 65 years and older), serious adverse events within 1 month of vaccination were reported in 327 of 42,237 (0.8%) Prevnar 13 recipients (352 events) and in 314 of 42,225 (0.7%) placebo recipients (337 events). Safety Assessments in the Catch-Up Studies in Infants and Children Through 5 Years of Age. 1995;10:511-2. Do not freeze. Serious adverse events were also collected throughout the study period. (Diphtheria CRM197 Protein), Prevnar, Pneumovax 23, pneumococcal 13-valent vaccine. Each dose was approximately 20 times the human dose. 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. In 5 of the 6 safety and immunogenicity studies, more females than males were enrolled (50.2% – 61.8%). A US study5 (Study 5) evaluated the use of Prevnar 13 in children previously immunized with Prevnar. Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine [see Description (11)]. All 4 events occurred in a single clinical trial in Brazil in which subjects received whole cell pertussis vaccine at the same time as Prevnar 13 or Prevnar. Overall, the safety data show a similar proportion of Prevnar 13 and Prevnar subjects reporting serious adverse events. In this study, the efficacy of Prevnar against invasive disease due to S. pneumoniae in cases accrued during this period was 100% in both the per-protocol and intent-to-treat analyses (95% confidence interval [CI]: 75.4%, 100% and 81.7%, 100%, respectively). Noninferiority was demonstrated for each IIV4 vaccine strain evaluated in Study 13.

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