S. pneumoniae is one of the most common causes of bacterial AOM worldwide. However, with pneumonia, the cough often produces yellow, green, or even bloody mucus. OPA GMTs after the toddler dose relative to those after the infant series were similar or lower for 4 serotypes (4, 14, 18C, and 19F) and were statistically significantly higher for 6 of 13 serotypes (1, 3, 5, 7F, 9V, and 19A) in preterm infants compared to 10 of 13 serotypes (1, 3, 4, 5, 6A, 7F, 9V, 18C, 19A, and 23F) in term infants. S. pneumoniae is the most frequent cause of CAP, and is estimated to be responsible for approximately 30% of all CAP cases requiring hospitalisation in adults in developed countries. Efficacy was demonstrated for the primary and secondary endpoints in the per protocol population (Table 5). For 9 serotypes, the OPA titers were shown to be statistically significantly greater in Prevenar 13 recipients. In fact, adults age 65 and older have a higher risk of death from pneumonia hospitalization than any other reason. In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). Unvaccinated infants and children ≥ 7 months of age. The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Reporting suspected adverse reactions after authorisation of the medicinal product is important. Different injectable vaccines should always be given at different vaccination sites. NNV is not a rate but instead indicates the number of cases prevented for a given number of persons vaccinated. 1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein and 0.125 mg aluminium. For 6 of the remaining 7 common serotypes, similar rates of NP acquisition were observed in both vaccine groups; for serotype 19F a significant reduction was observed. In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The study demonstrated that safety and immunogenicity were generally comparable with observations made in studies of intramuscular administration. Efficacy study in adults 65 years and older. Approximately one month after the toddler dose, the proportion of subjects in each group achieving this same antibody concentration threshold was >97%, except for serotype 3 (71% in preterm infants and 79% in term infants). Subcutaneous administration of Prevenar 13 was evaluated in a non-comparative study in 185 healthy Japanese infants and children who received 4 doses at 2, 4, 6 and 12-15 months of age. The need for revaccination with a subsequent dose of Prevenar 13 has not been established. General disorders and administration site conditions: Pyrexia; irritability; any vaccination-site erythema, induration/swelling or pain/tenderness; somnolence; poor quality sleep, Vaccination-site erythema or induration/swelling 2.5 cm–7.0 cm (after the booster dose and in older children [age 2 to 5 years]), Pyrexia > 39°C; vaccination-site movement impairment (due to pain); vaccination-site erythema or induration/swelling 2.5 cm–7.0 cm (after infant series), Vaccination-site erythema, induration/swelling > 7.0 cm; crying, Adverse reactions from Prevenar 13 postmarketing experience. These observations are consistent with adequate priming (the induction of immunologic memory). All seven common serotypes met pre-defined non-inferiority criteria for IgG ELISA GMCs. essentially 'sodium-free'. Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar. While direct cause-and-effect cannot be inferred from observational analyses of this type, these findings suggest that Prevenar plays an important role in reducing the burden of mucosal disease (AOM and pneumonia) in the target population. In adults, an antibody threshold of serotype-specific pneumococcal polysaccharide IgG binding antibody concentration associated with protection has not been defined. Bacteria can be responsible for 60-70 % of clinical episodes of AOM. Some men with an enlarged prostate gland (benign prostatic hyperplasia, or BPH for short) eventually start to experience urinary incontinence, the involuntary discharge of urine. An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13. Euro Surveill. Local reactions and systemic events were solicited daily after each vaccination for 14 days in 6 studies and 7 days in the remaining study. In Table 6, NNV is a measure that quantifies the number of people that need to be vaccinated in order to prevent one clinical CAP case. 4Children < 5 years of age. It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk. HIV-infected children and adults with CD4 ≥ 200 cells/µL (mean 717.0 cells/μL), viral load < 50,000 copies/ml (mean 2090.0 copies/ml), free of active AIDS-related illness and not previously vaccinated with a pneumococcal vaccine received 3 doses of Prevenar 13. One year after vaccination with Prevenar 13 OPA titers had declined compared to one month after vaccination, however OPA titers for all serotypes remained higher than levels at baseline. Prevenar 13 elicited functional antibodies to all 13 vaccine serotypes in studies 004 and 006. Pneumococcal polysaccharide conjugate vaccine. In a surveillance study in France in children presenting with acute otitis media, changes in nasopharyngeal (NP) carriage of pneumococcal serotypes were evaluated following the introduction of Prevenar (7-valent) and subsequently Prevenar 13. A single dose of Prevenar 13 was given to children 5 to 10 years of age previously vaccinated with at least 1 dose of Prevenar, and children and adolescents 10 to 17 years of age who had never received a pneumococcal vaccine. The first dose may be administered from the age of 2 months, with a second dose 2 months later. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. When Prevenar 13 is administered concomitantly with Infanrix hexa (DTPa-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of Prevenar (7-valent) and Infanrix hexa (see section 4.8). Date of first authorisation: 09 December 2009, Date of latest renewal: 18 September 2014, Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. 22–30 Park Avenue In clinical studies, the safety profile of Prevenar 13 was similar to Prevenar. In a retrospective evaluation of a large US insurance database, AOM visits were reduced by 42.7 % (95 % CI, 42.4-43.1 %), and prescriptions for AOM by 41.9 % in children younger than 2 years of age, compared with a pre-licensure baseline (2004 vs. 1997-99). High risk children under 5 years who have not completed a course of PCV13 vaccine are eligible to receive age-appropriate catch up doses. Medsafe. Pneumonia is the most common clinical presentation of pneumococcal disease in adults. You only need to activate your account once. Systemic reactions (chills, rash and myalgia) may occur when Prevenar 13 and influenza vaccine are administered at the same time. Each study included healthy adults and immuno-competent adults with stable underlying conditions known to predispose individuals to pneumococcal infection (i.e., chronic cardiovascular disease, chronic pulmonary disease including asthma, renal disorders and diabetes mellitus, chronic liver disease including alcoholic liver disease), and adults with risk factors such as smoking and alcohol abuse. Table 5: Vaccine efficacy (VE) for the primary and secondary endpoints of the CAPiTA study (per protocol population), First episode of confirmed VT pneumococcal CAP, First episode of confirmed NB/NI1 vaccine type pneumococcal CAP, 2VT-IPD - vaccine-type invasive pneumococcal disease. The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13. A fourth (booster) dose of Prevenar 13 was administered 6 months after the third dose. As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low (see section 5.1). During storage, a white deposit and clear supernatant can be observed. In addition to antibiotics, other treatments include rest, adequate fluids, and supplemental oxygen to raise the level of oxygen in the blood. To bookmark a medicine you must sign up and log in. Androgens, the family of male sex hormones that includes testosterone, function as a fuel for growth in normal development. Children and adolescents 6 to 17 years of age. Prevenar 13 immunogenicity clinical studies in infants, children and adolescents. Non-inferiority was met for the 6 additional serotypes based on the proportion of infants achieving antibody concentrations ≥ 0.35 μg/ml and comparison of IgG ELISA GMCs in study 006 and was met for 5 out of the 6 serotypes, with the exception of serotype 3 for study 004. In a French study, overall carriage was reported to be significantly lower among children who received at least one doses of Prevenar 13 compared with those who were exclusively vaccinated with Prevenar. Adults 65 and older should receive Prevnar first, followed by Pneumovax six months to one year later. Both articles and products will be searched. * The serotype in Prevenar with the lowest percent response rate was 6B in study 006 (87.1 %). Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness. This does not constitute a sign of deterioration. Effets indésirables. Immunisation handbook [Internet]. After the second and third dose of Prevenar 13, immune responses were comparable or higher than those after the first dose. Therefore the use of Prevenar 13 should be avoided during pregnancy. Clinical studies have been conducted in a number of European countries and the US using a range of vaccination schedules, including two randomised non-inferiority studies (Germany using a 2, 3, 4 month primary series [006] and US using a 2, 4, 6 month primary series [004]). 3 Based on a 5-year duration of protection. Medicare Part B covers pneumonia vaccines for adults. Enter search terms and tap the Search button. In the same study another group of adults aged 50-59 years and another group of adults aged 18-49 years received a single dose of Prevenar 13. The response to serotype 6A, which is unique to Prevenar 13, was assessed by demonstration of a 4-fold increase in the specific OPA titer above pre-immunised levels. Complete effectiveness for routine 2+1 schedule not yet available. Immune responses in preterm and term infants were compared using the proportion of subjects achieving a pneumococcal polysaccharide IgG binding antibody concentration ≥0.35 μg/ml 1 month after the infant series, the approach used for immunogenicity comparisons of Prevenar 13 to Prevenar based on WHO guidelines. Prevenar (7-valent vaccine) protective efficacy in infants and children. In fact, adults age 65 and older have a higher risk of death from … As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses. Available from: Plosker GL.13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents. Additional information in special populations: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4). For 9 serotypes, immune responses were related to age, with adults in the 50-59 years group showing statistically significantly greater responses than adults aged 60-64 years. The clinical significance of this is unknown. The proportion of infants achieving a pneumococcal anti-capsular polysaccharide IgG concentration ≥ 0.35 μg/ml one month after the second dose ranged from 79.6% to 98.5% across 11 of the 13 vaccine serotypes. Table 8: OPA GMTs in adults aged 18-49 years and 60-64 years given Prevenar 13a,b. A similar inflammation of the lung, called pneumonitis, can be caused by an inhaled chemical and is more common in people who have had strokes and have difficulty swallowing. Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. You also may have trouble breathing after activities like climbing a few stair steps, and experience pain when taking a deep breath. For serotype 3, the percentages of Prevenar 13 recipients with serum IgG ≥ 0.35 μg/ml were 98.2% (study 006) and 63.5% (study 004). Separate syringes and different injection sites should be used. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown (see section 5.1). In all adults ≥ 50 years who received a single dose of Prevenar 13, the OPA titers to serotype 6A were significantly greater than in adults ≥ 60 years who received a single dose of 23-valent pneumococcal polysaccharide vaccine. Beside getting vaccinated, you can reduce your risk of pneumonia by washing your hands frequently through the day, and seeing your doctor if you do get the flu so you can receive prompt treatment and avoid having it turn into pneumonia. Getting organized can help you spend less time searching for things. Do not use if the content appears otherwise. * Patients with at least 2 of the following: Cough; purulent sputum, temperature > 38°C or < 36.1°C; pneumonia (auscultatory findings); leukocytosis; C-reactive protein value > 3 times the upper limit of normal; hypoxemia with a partial oxygen pressure < 60 mmHg while breathing room air. Regardless of prior pneumococcal vaccination status, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first (see sections 4.5 and 5.1). Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa (see section 4.8). If a child aged under 5 years needs both Prevenar 13 and influenza vaccines, separation of vaccines by two days can be offered. Prevenar 13 is recommended and funded as below. Adults aged 65 years or older may only need 1 dose. In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5). 2 Per 100,000 person-years of observation. Results for study 004 were similar. Pack sizes of 1, 10 and 50, with or without needle. Pharmacotherapeutic group: vaccines, pneumococcal vaccines; ATC code: J07AL02. The reductions ranged between 34% and 62% depending on serotype and antibiotic. Following the booster dose, antibody concentrations increased from the pre-booster level for all 13 serotypes. Limited data have demonstrated that Prevenar 7-valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1). Who should get the pneumococcal vaccine? However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). As recommended by the World Health Organization (WHO) the assessment of potential efficacy against IPD in infants and young children has been based on a comparison of immune responses to the seven common serotypes shared between Prevenar 13 and Prevenar, for which protective efficacy has been proven (for Prevenar (7-valent) efficacy in infants and children, see below). How does inflammation increase the risk for heart attacks? A Guide to Men's Health: Fifty and Forward: Keep your shoulders strong to stay independent, Don’t trust this smartphone app to measure your blood pressure, Dementia rate may be on the decline, major cardiovascular study indicates, Unstable knees may contribute to recurrent falls and injuries, Get trusted advice from the doctors at Harvard Medical School, Learn tips for living a healthy lifestyle, Stay up-to-date on the latest developments in health, Receive special offers on health books and reports. Data published by Public Health England showed that, four years after the introduction of Prevenar as a two dose primary infant series with booster dose in the second year of life and with a 94% vaccine uptake, there was a 98% (95% CI 95; 99) reduction in disease caused by the 7 vaccine serotypes in England and Wales. In these two studies pneumococcal immune responses were compared using a set of non-inferiority criteria including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG ≥ 0.35 μg/ml one month after the primary series and the comparison of IgG geometric mean concentrations (ELISA GMCs); in addition, functional antibody titres (OPA) between subjects receiving Prevenar 13 and Prevenar were compared. By continuing to browse the site you are agreeing to our policy on the use of cookies. The decrease in all cause pneumonia cases was most pronounced in the younger vaccinated age groups with a decrease of 31.8% (757 to 516 cases) and 16.6% (833 to 695 cases) in the age groups <2 years and 2 to 5 years, respectively. Specialist advice should be sought for the following groups: There is good evidence that pneumococcal conjugate vaccines given in infancy help to protect non-vaccinated individuals from invasive pneumococcal disease caused by serotypes in the vaccines through community (herd) immunity. Prevenar 13 is funded for children and adults with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule, identified as 'special groups on the National Immunisation Schedule. OPA titres are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 %. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 2010 [updated 2019 August 22; cited 2020 July 1]. A post-hoc analysis was used to estimate the following public health outcomes against clinical CAP (as defined in the CAPiTA study, and based on clinical findings regardless of radiologic infiltrate or etiologic confirmation): vaccine efficacy (VE), incidence rate reduction (IRR), and number needed to vaccinate (NNV) (Table 6). The recommended immunisation series consists of four doses, each of 0.5 ml. The benefit of vaccination in very premature infants and those with a previous history of respiratory immaturity is high. Lymphadenopathy (localised to the region of the vaccination-site), Anaphylactic/anaphylactoid reaction including shock; angioedema, Vaccination-site urticaria; vaccination-site dermatitis; vaccination-site pruritus; flushing. Available from: Ministry of Health. However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines. The annual overall pneumococcal incidence of OM declined from 9.6 to 2.1 cases per 1000 children (78%) between July 2004 (prior to the introduction of Prevenar) and June 2013 (post Prevenar 13 introduction). A significant increase was seen in the concentrations of antibodies against the seven serotypes after the polysaccharide vaccination, suggesting that immunological memory was well established. 2015;75(13):1535-46, Weiss S, Falkenhorst G, van der Linden M, Imöhl M, von Kries R. Impact of 10- and 13-valent pneumococcal conjugate vaccines on incidence of invasive pneumococcal disease in children aged under 16 years in Germany, 2009 to 2012. For children aged from 7 months to 5 years, age appropriate catch-up immunisation schedules (as described in section 4.2) result in levels of anti-capsular polysaccharide IgG antibody responses to each of the 13 serotypes that are at least comparable to those of a three-dose primary series in infants. The efficacy of 7-valent Prevenar was evaluated in two major studies – the Northern California Kaiser Permanente (NCKP) study and the Finnish Otitis Media (FinOM) study. There was no carriage of serotypes 1 and 5 observed. The serotype specific reductions for each of the 5 additional serotypes in Prevenar 13 (no cases of serotype 5 IPD were observed) by age group are shown in Table 2 and ranged from 68% (serotype 3) to 100% (serotype 6A) for children less than 5 years of age. Prevenar 13 can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines except other pneumococcal vaccines, e.g. Should I worry about a sudden swollen tongue? – By Matthew SolanExecutive Editor, Harvard Men's Health Watch. As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation. The two vaccines build immunity against different types of the bacteria that causes pneumonia. Table 9: OPA GMTs in pneumococcal polysaccharide vaccinated adults aged ≥ 70 years given either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23)a,b,c. The fourth (booster) dose is recommended between 11 and 15 months of age (see sections 4.4 and 5.1). There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. Adults with an haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common. In addition there is good evidence that vaccinating young children reduces the amount of carriage (people who carry the bacteria in their nose and throat but do not get sick from it) in the population. Acute otitis media (AOM) is a common childhood disease with different aetiologies. Following the widespread use of Prevenar, the incidence of IPD has been consistently and substantially reduced. The clinical relevance of these differences is not known. This information is intended for use by health professionals, Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed), Pneumococcal polysaccharide serotype 18C1, Pneumococcal polysaccharide serotype 19A1, Pneumococcal polysaccharide serotype 19F1, Pneumococcal polysaccharide serotype 23F1. The immunogenicity after two doses in infants has been documented in four studies. One year after the second dose, antibody levels measured by both IgG GMCs and OPA GMTs were higher than levels prior to the first dose of Prevenar 13, except for the IgG GMCs for serotypes 3 and 5 that were numerically similar. After the infant series, OPA GMTs were similar in preterm infants compared to term infants except for serotype 5, which was lower in preterm infants. A physical exam, chest x-ray, and blood test can confirm a diagnosis. Prevenar 13 significantly reduced NP carriage of the 6 additional serotypes (and serotype 6C) combined and individual serotypes 6C, 7F, 19A when compared with Prevenar. Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule. The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm, Convulsions (including febrile convulsions). Pivotal trials for Prevenar 13 were designed to show that functional OPA antibody responses for the 13 serotypes are non-inferior, and for some serotypes superior, to the 12 serotypes in common with the licensed 23-valent pneumococcal polysaccharide vaccine [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] one month after vaccine administration. Continue, 2. The vaccine should be shaken well to obtain a homogeneous white suspension prior to expelling air from the syringe, and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. In this study, an overall decrease in meningitis was limited to vaccinated children aged 2–4 years. Prevenar 13 was administered to 48,806 adults; 2,616 (5.4%) aged 50 to 64 years, and 45,291 (92.8%) aged 65 years and older. OPA geometric mean titers (GMTs) measured 1-month after each vaccination were calculated. This site uses cookies. By activating your account, you will create a login and password. Grafton, Auckland Additional Prevenar (7-valent) immunogenicity data: children with sickle cell disease. The effectiveness (both direct and indirect effect) of 7-valent Prevenar against pneumococcal disease has been evaluated in both three-dose and two-dose primary infant series immunisation programmes, each with booster doses (Table 4).
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