However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown (see section 5.1). It is the most common cause of hospital admissions after childbirth. Store as per cold chain between 2°C to 8°C. 84,496 subjects, 65 years and older received a single vaccination of either Prevenar 13 or placebo in a 1:1 randomisation. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, local tolerance, and reproduction and developmental toxicity. An open label single arm study in France, Italy, UK, US, Lebanon, Egypt and Saudi Arabia with 2 doses of Prevenar 13 given 6 months apart was conducted in 158 children and adolescents ≥6 to <18 years of age with sickle cell disease who were previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine at least 6 months prior to enrollment. 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). Systemic reactions (chills, rash and myalgia) may occur when Prevenar 13 and influenza vaccine are administered at the same time. Antibody persistence and immunological memory were evaluated in a study in healthy children who received a single dose of Prevenar 13 at least 2 years after they had been previously immunised with either 4 doses of Prevenar, a 3-dose infant series of Prevenar followed by Prevenar 13 at 12 months of age, or 4 doses of Prevenar 13. a Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5. b Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1. c For serotype 6A†, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR being greater than 2. In a similar analysis, hospitalisations and ambulatory visits for all-cause pneumonia were reduced by 52.4 % and 41.1 %, respectively. The effect of pneumococcal conjugate vaccination on nasopharyngeal carriage was studied in a randomised double-blind study in which infants received either Prevenar 13 or Prevenar (7-valent) at 2, 4, 6 and 12 months of age in Israel. However, otitis media also caused by other types of bacteria which are not protected against by this vaccine. NNV also incorporates the length of the trial or duration of protection and is calculated as 1 divided by the product of the IRR and duration of protection (or length of trial) (=1/(IRR × duration). OPA geometric mean titers (GMTs) measured 1-month after each vaccination were calculated. 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%). As per general recommendations, a single dose of 23-valent pneumococcal polysaccharide vaccine was subsequently administered. 1 A Poisson regression model with random effects was used to calculate VE. Subsequently, four years following the switch to Prevenar 13, the additional reduction in incidence of IPD due to the 7 serotypes in Prevenar ranged from 76% in children less than 2 years of age to 91% in children 5-14 years of age. Based on serotype surveillance in Europe performed before the introduction of Prevenar, Prevenar 13 is estimated to cover 73-100 % (depending on the country) of serotypes causing invasive pneumococcal disease (IPD) in children less than 5 years of age. 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. The combination stimulates the immune system more effectively than either alone. Efficacy was demonstrated for the primary and secondary endpoints in the per protocol population (Table 5). Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine. Different injectable vaccines should always be given at different vaccination sites. After the booster dose, all vaccine serotypes including 6B and 23F had immune responses consistent with adequate priming with a two-dose primary series. It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13. The clinical relevance of these differences is not known. Prevenar 13 must not be administered intravascularly. 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). For children aged 2 years to under 18 years who received Pneumovax23 before a dose of Prevenar 13: Prevenar 13 should be given at least eight weeks after Pneumovax23. Separate syringes and different injection sites should be used. This decrease was not only observed in infants younger than 2 years but also older children, indicating herd immunity. For the most recent epidemiological information in your country you should consult with the relevant national organisation. The first dose was administered at 3 to 6 months after HSCT. 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. Functional antibody titers (OPA titers) were not measured in this study. No data are currently available regarding concomitant use with other vaccines. It may, in this situation only, be given subcutaneously. 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. There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. New Zealand, © Copyright 2017 Immunisation Advisory Centre, PCV13, 13-valent pneumococcal conjugate vaccine, New Zealand National Immunisation Schedule, Meningococcal disease information for health professionals, Zostavax resources for health professionals, http://www.medsafe.govt.nz/profs/Datasheet/p/prevenar13inj.pdf, https://www.health.govt.nz/publication/immunisation-handbook-2020, Prevenar 13 consumer medicine information sheet, Mild pain, redness and swelling around injection site, Hypotonic, hyporesponsive episode (HHE) in infants. Immune responses to serotype 6A were statistically significantly greater following vaccination with Prevenar 13 than after 23-valent pneumococcal polysaccharide vaccine. Should I worry about a sudden swollen tongue? Immune responses after subcutaneous administration. The no-drug approach to erectile dysfunction, A silent condition may be taking a toll on your health. Immunogenicity studies in adults ≥ 18 years and the elderly. Do not use if the content appears otherwise. * 95% CI inflated from a Poisson interval based on over-dispersion of 2.1 seen from modelling of 2000-06 pre-Prevenar all IPD data. In an open-label study in 592 healthy children and adolescents including those with asthma (17.4%) who may be predisposed to pneumococcal infection, Prevenar 13 elicited immune responses to all 13 serotypes. In a multicenter observational study in France comparing the periods before and after the switch from Prevenar to Prevenar 13, there was 16% (2060 to 1725 cases) reduction in all community acquired pneumonia (CAP) cases in emergency departments in children 1 month to 15 years of age. 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. Table 7 compares the OPA GMTs, 1-month post-dose, in 60-64 year olds given either a single dose of Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine, and in 50-59 year olds given a single dose of Prevenar 13. 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). Subjects who received two or more previous doses of 23-valent pneumococcal polysaccharide vaccine showed a similar immune response compared with subjects who received a single previous dose. Additional information in special populations. For the 7 common serotypes there were no differences between groups in the proportion of subjects with OPA titres ≥ 1:8. Drugs. To view the changes to a medicine you must sign up and log in. Pharmacotherapeutic group: vaccines, pneumococcal vaccines; ATC code: J07AL02. Vaccination should not be withheld or delayed in these babies, however, respiratory monitoring should be considered for 48–72 hours due to the potential risk of apnoea. However, missed doses of Prevenar 13 can be given even if the person has previously received one or more doses of Pneumovax23. Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).