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Slide 7 At the time of unbinding there were 40 fully vaccinated cases of invasive pneumococcal disease (IPD) caused by vaccine serotypes with all but 1 case in the control group. In the intent to treat (ITT) analysis (which included all randomised children regardless of whether they completed the vaccination schedule) there were 52 cases of IPD caused by the vaccine serotypes, with only 3 of these cases in the 7-PCV group. Six cases of IPD caused by non-vaccine serotype occurred in the control group. Three cases of IPD caused by non-vaccine serotypes occurred in the 7-PCV group. There was an 89.1% reduction in IPD burden in children who had received one or more doses of 7-PCV. Reference Black S et al. Pediatr Infect Dis J 2000; 19: 187-195

Slide 8 This table shows the serotypes, which caused disease in the 7-PCV group. The 1 vaccine failure was a child with bacteraemic pneumonia (serotype 19F) who had received 4 doses of vaccine. The 3 cases of vaccine serotype IPD in the ITT PCV group included: the fully vaccinated child mentioned above, a child who developed acute myelogenous leukaemia after vaccination & became bacteraemic (serotype 19F) while receiving immunosuppressive therapy, a partially vaccinated child who developed infection (serotype 6B) 317 days after a single dose. Six cases of IPD caused by non-vaccine serotypes occurred in the control group: serotypes 3, 6A, 11A, 18B, 19A & 38. Three cases of IPD caused by non-vaccine serotypes occurred in 7-PCV group: 10F, 38, 23A Reference Black S et al. Pediatr Infect Dis J 2000; 19: 187-195.

Slide 9 The effectiveness of 7-PCV against clinical and radiograph-confirmed pneumonia in children was also evaluated. A diagnosis of pneumonia included bronchopneumonia, viral pneumonia, pneumonia with consolidation and pleural empyema. X-rays were only taken at time of illness if the treating physician needed it for treatment purposes, and they were read only once by the responsible radiologist. X-rays were classified as follows: Normal: no abnormalities Perihilar: perihilar infiltrates only Positive: infiltrates beyond the perihilar area or consolidation or empyema. The results of vaccine effectiveness in all ages for both intent to treat and per protocol infants are shown here. At the time of unblinding the children were aged up to 3 years and 6 months. Reference Black S et al. Pediatr Infect Dis J 2002; 21: 810–15

Slide 10 Nine children in the ITT analysis had bacteraemic pneumonia, one in the 7-PCV group, 8 in the control group, for a vaccine efficacy of 87.5%. Overall, there was a 90.0% reduction in bacteraemic pneumonia burden in children who had received one or more doses of 7-PCV. Reference Black S et al. Pediatr Infect Dis J 2002; 21: 810–15

Slide 11 Since the year 2000, the United States Advisory Committee on Immunization Practices (ACIP) has recommended vaccination for all infants ≤23 months of age, plus all children 24–59 months of age with the following conditions: Sickle cell anaemia, splenic dysfunction, HIV, chronic diseases, immunodeficiency. They also recommend that vaccination should be considered for all other children aged 24–59 months, particularly those who are: 24–35 months old, African-American, Native American, Alaskan Native, or in group daycare. Reference MMWR 2000 49 RR-9 1-38

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