Pneumococcal serotype-specific opsonophagocytic activity geometric mean titer before and after PHiD-CV or control vaccine.

<p>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.</p

Pneumococcal serotype-specific IgG geometric mean concentration before and after PHiD-CV or control vaccine.

<p>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).</p

Proportion of participants with serotype-specific IgG ≥0.35 mcg/mL (A) and OPA≥8 (B).

<p>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 <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085459#pone-0085459-g002" target="_blank">Figure 2</a> and <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085459#pone-0085459-g003" target="_blank">Figure 3</a>. See also <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085459#pone.0085459.s001" target="_blank">Tables S1</a> and <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0085459#pone.0085459.s002" target="_blank">S2</a>. <b>*</b>Serotypes for which the confidence intervals are non-overlapping for proportions meeting the specified threshold post-dose 1 and post-dose 2.</p

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).

<p>IgG GMC N (range): Group A (119–121); Group B (100–115).</p><p>OPA GMT N (range): Group A (62–120); Group B (54–113).</p><p>LL = lower limit of 95% confidence interval; UL = upper limit of 95% confidence interval.</p>*<p>Paired t-test of log concentration.</p

Trial profile.

<p>Trial profile.</p

Participant Characteristics.

<p>MUAC = mid upper arm circumference.</p><p>IQR = interquartile range.</p

Vaccination schedule.

<p>The following vaccines were used: PHiD-CV, Synflorix; diphtheria–tetanus–acellular pertussis–hepatitis B–inactivated poliovirus–<i>Haemophilus influenzae</i> type b vaccine (DTPa-HBV-IPV/Hib), Infanrix hexa; DTPa-IPV/Hib, Infanrix-IPV/Hib; hepatitis B, Engerix-B; hepatitis A, Havrix (all by GlaxoSmithKline Vaccines). In addition to these blinded study vaccines, the following vaccines were administered or were recommended: measles–mumps–rubella vaccine at 12 mo of age, hepatitis B vaccination at birth, and hepatitis A vaccination at 12 and 18–21 mo of age, with the second dose given at least 28 days after the study vaccine booster dose. In Argentina, <i>Neisseria meningitidis</i> group C conjugate vaccine (NeisVac-C, Baxter International) was offered at 12 mo of age; in Colombia and Panama, varicella vaccine (Varilrix, GlaxoSmithKline Vaccines) was offered at 12 mo of age; in Colombia, two doses of oral rotavirus vaccine (Rotarix, GlaxoSmithKline Vaccines) were offered within the first 6 mo of life.</p

Trial profile for children included in the analysis of the primary study end point.

<p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. ^aForbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p

Trial profile for children included in the end-of-study analysis of acute otitis media.

<p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. ^aForbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p

Inclusion and exclusion criteria.

<p>Inclusion and exclusion criteria.</p