The 10-valent and 13-valent conjugate vaccines were registered for young children based on non-inferiority of immunogenicity compared with the 7-valent vaccine. There are no definitive serological correlates of clinical protection against the whole spectrum of pneumococcal disease, especially where specific serotypes are concerned. Currently, clinical efficacy data are not available for either of these two vaccines.
10-valent vaccine (Synflorix)
This vaccine was approved in 2009 for children. While its clinical efficacy is yet to be published, a study of a prototype vaccine containing 11 pneumococcal serotypes (the 10 serotypes in the 10-valent plus serotype 3), also conjugated to H. influenzae protein D, showed significant protective efficacy against acute otitis media caused by vaccine serotypes (57.6%; 95% CI 41.4–69.3%) as well as by H. influenzae (35.6%; 95% CI 3.8–57.0%).18
The safety profile of the 10-valent vaccine is similar to that of the 7-valent vaccine, with no clinically relevant difference when co-administered with routine childhood vaccines.19
There are no specific data available that address the immunogenicity and safety around the interchangeability of the 10-valent vaccine and other CRM 197 -conjugated vaccines (see Table 1). However, a mixed schedule consisting of different conjugate vaccines necessitated by changes in vaccination programs is considered acceptable.
13-valent vaccine (Prevenar 13)
Children
This vaccine was approved in 2010 for children. Because of the extensive postmarketing data on the 7-valent vaccine, and established immunologic correlates of protection against invasive pneumococcal disease in children, efficacy trials have not been conducted.20 Licensing in Australia has been based on non-inferiority of immunogenicity for the 7-valent conjugate vaccine serotypes and comparable antibody responses to the additional serotypes. This includes serotype 19A, which has emerged as the dominant serotype in Australia. Field effectiveness against invasive pneumococcal disease caused by the additional serotypes contained in 13-valent vaccine has been shown.21
The safety profile of the 13-valent vaccine is similar to that of the 7-valent vaccine.22 However, post-licensure surveillance in the USA has suggested that there is a slightly higher risk of febrile seizures in young children within a day of concurrent administration with inactivated trivalent influenza vaccine compared with the vaccines given alone on separate days (especially in children aged 12–23 months).23 Concurrent administration of these two vaccines is considered acceptable. However, if relevant, parents should be given the option of having the vaccines separately at least three days apart.6
Adults
In 2011, the 13-valent vaccine was registered in Australia for adults aged 50 years and over, based on immunogenicity data showing comparable or better antibody responses compared to the 23-valent polysaccharide vaccine for the shared vaccine serotypes.
There is only limited safety information on the 13-valent conjugate vaccine in adults. Pain, redness and swelling at the injection site is observed in about half of vaccine recipients. Concurrent administration of trivalent inactivated seasonal influenza vaccine with the 13-valent vaccine may increase the frequency of systemic but not local reactions.24