Figure 1.
Trial profile.
Table 1.
Participant Characteristics.
Figure 2.
Pneumococcal serotype-specific IgG geometric mean concentration before and after PHiD-CV or control vaccine.
Pneumococcal serotype-specific IgG geometric mean concentration with 95% confidence interval among children aged 12–59 months before and after PHiD-CV (Groups A and B) or control vaccine (Group C). Group A N (range) by day for GMC: day 0 (125–127); day 30 (124); day 90 (120–122) Group B N (range) by day for GMC: day 0 (121–124); day 30 (119–120); day 210 (101–115) Group C N (range) by day for GMC: day 0 (121–124); day 30 (119–121); day 90 (117–119).
Figure 3.
Pneumococcal serotype-specific opsonophagocytic activity geometric mean titer before and after PHiD-CV or control vaccine.
Pneumococcal serotype-specific opsonophagocytic activity geometric mean titer and 95% confidence interval among children aged 12–59 months before and after PHiD-CV (Groups A and B) or control vaccine (Group C). Group A N (range) by day: day 0 (0–110); day 30 (66–124); day 90 (104–121) Group B N (range) by day: day 0 (0–102); day 30 (60–119); day 210 (97–115) Group C N (range) by day: day 0 (3–109); day 30 (2–118); day 90 (2–118) Results for serotype 5 at day 0 not available because of insufficient specimen volume.
Table 2.
Ratio of serotype-specific IgG geometric mean concentration (GMC) and OPA geometric mean titer (GMT) post-dose 2 (day 90 for Group A or day 210 for Group B) : post-dose 1 (day 30).
Figure 4.
Proportion of participants with serotype-specific IgG ≥0.35 mcg/mL (A) and OPA≥8 (B).
Proportion of children aged 12–59 months with serotype-specific IgG ≥0.35 mcg/mL (A) and OPA≥8 (B) at baseline and following one and two doses of PHiD-CV. Results for Groups A and B were similar so combined results are presented. Numbers of subjects sampled are shown in Figure 2 and Figure 3. See also Tables S1 and S2. *Serotypes for which the confidence intervals are non-overlapping for proportions meeting the specified threshold post-dose 1 and post-dose 2.
Figure 5.
Nasopharyngeal carriage among children aged 12–59 months before and after PHiD-CV or control vaccine.
Nasopharyngeal carriage of vaccine-type pneumococci (A), non-vaccine type pneumococci (B) and non-typeable H. influenzae (C) among children aged 12–59 months before and after PHiD-CV or control vaccine. N = 192–200 subjects per group per timepoint. See also Table S4. *p-value <0.05, comparing carriage between Group A and Group C. #p-value <0.05, comparing carriage between Group B and Group C.
Table 3.
Solicited adverse events among children aged 12–59 months during the three days following dose 1 or dose 2 of PHiD-CV or control vaccine.