Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: A cluster randomised trial

Department of Vaccination and Immune Protection, National Institute for Health and Welfare, Tampere, Finland. Electronic address: .
The Lancet (Impact Factor: 45.22). 11/2012; 381(9862). DOI: 10.1016/S0140-6736(12)61854-6
Source: PubMed


Vaccine effectiveness of pneumococcal conjugate vaccines against culture-confirmed invasive pneumococcal disease has been well documented. In the Finnish Invasive Pneumococcal disease (FinIP) trial, we reported vaccine effectiveness and absolute rate reduction against laboratory-confirmed invasive pneumococcal disease (confirmation by culture or antigen or DNA detection irrespective of serotype). Here, we assessed vaccine effectiveness of PHiD-CV10 against clinically suspected invasive pneumococcal disease in children by use of diagnoses coded in hospital discharge registers.

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    • "Vaccine efficacy against this 2 + 1 schedule was reported to be 92%.[41] Safety profiles were confirmed from many trials including the recent trial reported from 12 sites in India.[414243] Like Hib vaccines, this also prevents colonization thereby facilitates the protection against the disease transmission.[4445] "
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    ABSTRACT: Acute respiratory infections (ARIs) are the leading cause of death among children less than 5 years in India. Emergence of newer pathogenic organisms, reemergence of disease previously controlled, wide spread antibiotic resistance, and suboptimal immunization coverage even after many innovative efforts are major factors responsible for high incidence of ARI. Drastic reduction in the burden of ARI by low-cost interventions such as hand washing, breast feeding, availability of rapid and feasible array of diagnostics, and introduction of pentavalent vaccine under National Immunization Schedule which are ongoing are necessary for reduction of ARI.
    03/2014; 5(1):15-20. DOI:10.4103/0976-9668.127275
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    • "Effectiveness of a 2+1 dosing schedule has been shown effective against VT-IPD among partially vaccinated children in the United States where a 3+1 schedule is routinely used, and disease reductions were seen in several European countries and Quebec, Canada, where the national immunization program implemented a 2+1 schedule with a catch-up campaign. Since completion of our literature search, a cluster-randomized, double-blind clinical trial was published that directly compared a 2+1 schedule to a 3+1 schedule using a 10-valent protein D PCV (PCV10) in Finland.15 In this study, vaccine effectiveness was 92% (95% CI: 58–100) with 2+1 doses and 100% (95% CI: 83–100%) with 3+1 doses, which is similar to estimates observed in clinical trials using 3+1 or 3+0 schedules in the United States, South Africa and The Gambia.11–14 "
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    ABSTRACT: Pneumococcal conjugate vaccines (PCV) are being implemented globally using a variety of different schedules. The optimal schedule to maximize protection of vaccinated children against vaccine-type invasive pneumococcal disease (VT-IPD) is not known. To assess the relative benefit of various PCV dosing schedules, we conducted a systematic review of studies published in English from 1994 to 2010 (supplemented post hoc with studies from 2011) on PCV effectiveness against VT-IPD among children targeted to receive vaccine. Data on 2-dose and 3-dose primary series, both with and without a booster ("2+0," "2+1," "3+0" and "3+1"), were included. For observational studies using surveillance data or case counts, we calculated percentage reduction in VT-IPD before and after PCV introduction. Of 4 randomized controlled trials and 31 observational studies reporting VT-IPD among young children, none evaluated a 2+0 complete series, 7 (19%) evaluated 2+1, 4 (11%) 3+0 and 27 (75%) 3+1. Most (86%) studies were from North America or Europe. Only 1 study (observational) directly compared 2 schedules (3+0 vs. 3+1); results supported the use of a booster dose. In clinical trials, vaccine efficacy ranged from 65% to 71% with 3+0 and 83% to 94% with 3+1. Surveillance data and case counts demonstrate reductions in VT-IPD of up to 100% with 2+1 (6 studies) or 3+1 (17 studies) schedules and up to 90% with 3+0 (2 studies). Reductions were observed as early as 1 year after PCV introduction. These data support the use of 2+1, 3+0 and 3+1 schedules, although most data of PCV impact on VT-IPD among young children are from high-income countries using 3+1. Differences between schedules for impact on VT-IPD are difficult to discern based on available data.
    The Pediatric Infectious Disease Journal 01/2014; 33 Suppl 2(Suppl 2 Optimum Dosing of Pneumococcal Conjugate Vaccine For Infants 0 A Landscape Analysis of Evidence Supportin g Different Schedules):S109-18. DOI:10.1097/INF.0000000000000078 · 2.72 Impact Factor
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    • "While reports of clinical trials for 3+1 and 3+0 schedules were published between 2000 and 2005, the first randomized trial demonstrating efficacy for the 2+1 schedule was not published until 2012. This cluster-randomized trial in Finland38 evaluated both 2+1 schedule and 3+1 schedule for PCV10; the 2 schedules were each compared to a control group that received hepatitis B vaccine. Compared with 12 cases of vaccine-type invasive disease that occurred in the control group, no cases occurred among children receiving the 3+1 schedule (vaccine effectiveness 100%, 95% confidence interval (CI): 83–100%) and only 1 case occurred among children receiving the 2+1 schedule (vaccine effectiveness 92%, 95% CI: 58–100%). "
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    ABSTRACT: Since second generation pneumococcal conjugate vaccines (PCVs) targeting 10 and 13 serotypes became available in 2010, the number of national policy makers considering these vaccines has steadily increased. An important consideration for a national immunization program is the timing and number of doses-the schedule-that will best prevent disease in the population. Data on disease epidemiology and the efficacy or effectiveness of PCV schedules are typically considered when choosing a schedule. Practical concerns, such as the existing vaccine schedule, and vaccine program performance are also important. In low-income countries, pneumococcal disease and deaths typically peak well before the end of the first year of life, making a schedule that provides PCV doses early in life (eg, a 6-, 10- and 14-week schedule) potentially the best option. In other settings, a schedule including a booster dose may address disease that peaks in the second year of life or may be seen to enhance a schedule already in place. A large and growing body of evidence from immunogenicity studies, as well as clinical trials and observational studies of carriage, pneumonia and invasive disease, has been systematically reviewed; these data indicate that schedules of 3 or 4 doses all work well, and that the differences between these regimens are subtle, especially in a mature program in which coverage is high and indirect (herd) effects help enhance protection provided directly by a vaccine schedule. The recent World Health Organization policy statement on PCVs endorsed a schedule of 3 primary doses without a booster or, as a new alternative, 2 primary doses with a booster dose. While 1 schedule may be preferred in a particular setting based on local epidemiology or practical considerations, achieving high coverage with 3 doses is likely more important than the specific timing of doses.
    The Pediatric Infectious Disease Journal 01/2014; 33 Suppl 2(Suppl 2 Optimum Dosing of Pneumococcal Conjugate Vaccine For Infants 0 A Landscape Analysis of Evidence Supportin g Different Schedules):S172-81. DOI:10.1097/INF.0000000000000076 · 2.72 Impact Factor
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