A phase 3, randomized, double-blind trial comparing the safety and immunogenicity of the 7-valent and 13-valent pneumococcal conjugate vaccines, given with routine pediatric vaccinations, in healthy infants in Brazil

Weckx, Lily Yin; Thompson, Allison; Berezin, Eitan Naaman; Faria, Sônia Maria de; Cunha, Clóvis Arns da; Pride, Michael W.; Patterson, Scott D.; Gruber, William C.; Emini, Emilio A.; Scott, Daniel A.

doi:10.1016/j.vaccine.2012.10.040

Cited by 17 publications

(13 citation statements)

References 20 publications

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“…Several studies suggest that the effectiveness of PCV13 for serotype 3 is lower compared with other serotypes. [42][43][44][45][46][47] Although serotype 3 was still present in 2013, we observed a decrease in its prevalence and its genetic diversity, suggesting some effectiveness of PCV13 on preventing carriage of serotype 3. The persistence of 19F may be because of advantages caused by antimicrobial resistance, as the antimicrobial susceptible ST177 decreased in prevalence while the resistant ST179 increased.…”

Section: Discussionmentioning

confidence: 64%

“…By design, the vaccine uptake differed between samples. The uptake of the "new vaccine" did not differ between 2008 and 2013: 40% (35)(36)(37)(38)(39)(40)(41)(42)(43)(44) for PCV7 versus 42% (38)(39)(40)(41)(42)(43)(44)(45)(46) for at least 1 immunization with PCV13. In 2013, children were reported to have suffered from upper respiratory tract infections in the past 3 months slightly more often than in 2008 [2013: 9% (7-12); 2008: Table 4).…”

Section: Comparing the Pcv13 Sample With The Prevaccination And Pcv7 mentioning

confidence: 96%

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Decreased Carriage and Genetic Shifts in the Streptococcus pneumoniae Population After Changing the Seven-valent to the Thirteen-valent Pneumococcal Vaccine in Norway

Steens

Caugant²,

Aaberge

et al. 2015

Pediatric Infectious Disease Journal

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Carriage of PCV13 serotypes has decreased without a coinciding increase in non-PCV13 serotypes. The serotype and genetic shifts among non-PCV13 serotypes suggest that a new equilibrium has not yet been reached. As the few non-PCV13 serotypes that increased have generally a lower invasive capacity than vaccine serotypes, direct and indirect protection of PCV13 on invasive pneumococcal disease can be expected to continue.

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Section: Discussionmentioning

confidence: 64%

Section: Comparing the Pcv13 Sample With The Prevaccination And Pcv7 mentioning

confidence: 96%

Decreased Carriage and Genetic Shifts in the Streptococcus pneumoniae Population After Changing the Seven-valent to the Thirteen-valent Pneumococcal Vaccine in Norway

Steens

Caugant²,

Aaberge

et al. 2015

Pediatric Infectious Disease Journal

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“…Main characteristics of the nine studies included [23][24][25][26][27][28][29][30][31] are shown in Table 1. These clinical trials were published between 2010 and 2013, and were conducted in countries of Europe (44%), the Americas (33%), and Asia (22%).…”

Section: Description Of Included Studiesmentioning

confidence: 99%

“…Immune responses to serotypes after "infant series" were reported in six studies [23][24][25]27,29,31]. Fig.…”

Section: Immune Response After "Infant Series"mentioning

confidence: 99%

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: A meta-analysis

Ruiz-Aragón

Peláez

Molina-Linde

et al. 2013

Vaccine

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“…Immunization was almost always characterized by simultaneous administration of other pediatric vaccines; this confirms the absence of effect of additional PCV13 prescription on tolerance to the primary calendar vaccines. A clinical study performed in Brazil, where PCV13 was administered simultaneously with a whole cell DTP vaccine, is of high interest [22]. The obtained results demonstrated a reliable immune response to all the administered antigens and safety of use of PCV13 together with the main pediatric vaccine.…”

Section: Introductionmentioning

confidence: 90%

Experience of application and safety assessment of the 13-valent pneumococcal conjugate vaccine in under-5 children

Федосеенко¹,

Новикова²,

Ткаченко³

et al. 2014

PPh

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Compulsory use of the 7-valent pneumococcal conjugate vaccine in the framework of national pediatric immunization schedules of the developed countries resulted in significant decrease in the prevalence of the pneumococcal infections induced by the vaccinal serotypes. However, a growth in prevalence of the pneumonia and acute otitis media caused by non-vaccinal strains has also been observed. This required introduction of a new 13-valent pneumococcal conjugate vaccine with a wider range of pneumococcal population coverage. The experience of application accumulated in various countries (2010 onwards) and results of the authors' observations indicate high safety of the 13-valent pneumococcal conjugate vaccine for both healthy under-5 children and patients with various medical issues. The article presents results of the 13-valent pneumococcal conjugate vaccination tolerance assessment. The study involved 110 children from 2 months to 5 years of age. In most cases immunization concurred with other pediatric vaccines. The incidence of local reactions in vaccinated children did not exceed 33%, of generalized reactions-11%. The authors observed a comparable incidence of side reactions in both virtually healthy children and children with various medical issues.

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A phase 3, randomized, double-blind trial comparing the safety and immunogenicity of the 7-valent and 13-valent pneumococcal conjugate vaccines, given with routine pediatric vaccinations, in healthy infants in Brazil

Cited by 17 publications

References 20 publications

Decreased Carriage and Genetic Shifts in the Streptococcus pneumoniae Population After Changing the Seven-valent to the Thirteen-valent Pneumococcal Vaccine in Norway

Decreased Carriage and Genetic Shifts in the Streptococcus pneumoniae Population After Changing the Seven-valent to the Thirteen-valent Pneumococcal Vaccine in Norway

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: A meta-analysis

Experience of application and safety assessment of the 13-valent pneumococcal conjugate vaccine in under-5 children

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