| Study . | Age Category Prior to Immunization . | Preimmunizationa . | 28 d Postimmunizationb . | 1 Year Postimmunizationc . | 2 Years Postimmunizationd . | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | ||
| Study A | 12–23 mo | 201 | 14.3 (9.9–20.7) | 198 | 6234.5 (4947.9–7855.7) | 65 | 1035.0 (678.4–1578.9) | 64 | 1313.7 (875.1–1971.9) |
| 22–33 mo | 63 | 42.6 (20.3–89.4) | 58 | 9342.9 (7043.8–12 392.4) | 56 | 2527.6 (1796.9–3555.5) | |||
| Study B | 2–10 y | 202 | 209.8 (144.4–304.7) | 203 | 6743.2 (5900.7–7705.9) | 202 | 3485.9 (3086.4–3937.2) | ||
| 11–17 y | 202 | 264.9 (187.7–374.0) | 202 | 4618.7 (4029.4–5294.2) | 196 | 3075.8 (2641.6–3581.3) | |||
| 18–29 y | 199 | 199.9 (138.5–288.6) | 198 | 3331.6 (2872.3–3864.4) | 186 | 2206.5 (1837.6–2649.4) | |||
| Study C | 14–18 wk | 191 | 2.2 (2.1–2.2) | 189 | 1138.9 (866.3–1497.3) | ||||
| 9–12 mo | 186 | 3.2 (2.5–3.9) | 180 | 2776.2 (2290.7–3364.6) | 175 | 365.6 (259.2–515.8) | 170 | 481.6 (344.9–672.5) | |
| 12–18 mo | 187 | 7.8 (5.4–11.3) | 184 | 3170.4 (2656.6–3783.6) | 179 | 786.9 (595.2–1040.5) | 179 | 827.6 (610.1–1122.5) | |
| Study . | Age Category Prior to Immunization . | Preimmunizationa . | 28 d Postimmunizationb . | 1 Year Postimmunizationc . | 2 Years Postimmunizationd . | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | ||
| Study A | 12–23 mo | 201 | 14.3 (9.9–20.7) | 198 | 6234.5 (4947.9–7855.7) | 65 | 1035.0 (678.4–1578.9) | 64 | 1313.7 (875.1–1971.9) |
| 22–33 mo | 63 | 42.6 (20.3–89.4) | 58 | 9342.9 (7043.8–12 392.4) | 56 | 2527.6 (1796.9–3555.5) | |||
| Study B | 2–10 y | 202 | 209.8 (144.4–304.7) | 203 | 6743.2 (5900.7–7705.9) | 202 | 3485.9 (3086.4–3937.2) | ||
| 11–17 y | 202 | 264.9 (187.7–374.0) | 202 | 4618.7 (4029.4–5294.2) | 196 | 3075.8 (2641.6–3581.3) | |||
| 18–29 y | 199 | 199.9 (138.5–288.6) | 198 | 3331.6 (2872.3–3864.4) | 186 | 2206.5 (1837.6–2649.4) | |||
| Study C | 14–18 wk | 191 | 2.2 (2.1–2.2) | 189 | 1138.9 (866.3–1497.3) | ||||
| 9–12 mo | 186 | 3.2 (2.5–3.9) | 180 | 2776.2 (2290.7–3364.6) | 175 | 365.6 (259.2–515.8) | 170 | 481.6 (344.9–672.5) | |
| 12–18 mo | 187 | 7.8 (5.4–11.3) | 184 | 3170.4 (2656.6–3783.6) | 179 | 786.9 (595.2–1040.5) | 179 | 827.6 (610.1–1122.5) | |
Except for the preimmunization comparisons, the rest of the comparisons were using mixed-effect models. The outcome variables were log2-transformed titers. Age category prior to immunization and time (visit points) were the main fixed effects in the models. Study subject was the random effect. The baseline titer, sex, and interaction effects of baseline titer-by-age category, sex-by-age category, baseline titer-by-time, and time-by-age category were also included in the models.
Abbreviations: CI, confidence interval; GMT, geometric mean titer.
a Prior to immunization with PsA-TT: P = .0059 for the comparison of SBA GMTs between subjects vaccinated at 12–23 months and 22–33 months of age in study A using t test; P < .0001 for the comparisons between subjects vaccinated at 14–18 weeks and 12–18 months of age and between subjects vaccinated at 9–12 months and 12–18 months of age; and P = .0315 for the comparison between subjects vaccinated at 14–18 weeks and 9–12 months of age in study C using analysis of variance.
b At 28 days postimmunization with PsA-TT: P = .0003 for the comparison of SBA GMTs between subjects vaccinated at 2–10 years and 11–17 years of age, P < .0001 for the comparison between subjects vaccinated at 2–10 years and 18–29 years of age, P = .0023 for comparison between subjects vaccinated at 11–17 years and 18–29 years of age in study B; P < .0001 for the comparison between subjects vaccinated at 14–18 weeks and 9–12 months of age and between 14–18 weeks and 12–18 months of age in study C.
c One year postimmunization with PsA-TT: P = .0022 for the comparison of SBA GMTs between subjects vaccinated at 12–23 months and 22–33 months of age in study A; P < .0001 for the comparison between subjects vaccinated at 2–10 years and 18–29 years of age and P = .0038 for the comparison between subjects vaccinated at 11–17 years and 18–29 years of age in study B; P = .0026 for the comparison between subjects vaccinated at 9–12 months and 12–18 months of age in study C.
d Two years postimmunization with PsA-TT: P = .0282 for the comparison of SBA GMTs between subjects vaccinated at 9–12 months and 12–18 months of age in study C.
| Study . | Age Category Prior to Immunization . | Preimmunizationa . | 28 d Postimmunizationb . | 1 Year Postimmunizationc . | 2 Years Postimmunizationd . | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | ||
| Study A | 12–23 mo | 201 | 14.3 (9.9–20.7) | 198 | 6234.5 (4947.9–7855.7) | 65 | 1035.0 (678.4–1578.9) | 64 | 1313.7 (875.1–1971.9) |
| 22–33 mo | 63 | 42.6 (20.3–89.4) | 58 | 9342.9 (7043.8–12 392.4) | 56 | 2527.6 (1796.9–3555.5) | |||
| Study B | 2–10 y | 202 | 209.8 (144.4–304.7) | 203 | 6743.2 (5900.7–7705.9) | 202 | 3485.9 (3086.4–3937.2) | ||
| 11–17 y | 202 | 264.9 (187.7–374.0) | 202 | 4618.7 (4029.4–5294.2) | 196 | 3075.8 (2641.6–3581.3) | |||
| 18–29 y | 199 | 199.9 (138.5–288.6) | 198 | 3331.6 (2872.3–3864.4) | 186 | 2206.5 (1837.6–2649.4) | |||
| Study C | 14–18 wk | 191 | 2.2 (2.1–2.2) | 189 | 1138.9 (866.3–1497.3) | ||||
| 9–12 mo | 186 | 3.2 (2.5–3.9) | 180 | 2776.2 (2290.7–3364.6) | 175 | 365.6 (259.2–515.8) | 170 | 481.6 (344.9–672.5) | |
| 12–18 mo | 187 | 7.8 (5.4–11.3) | 184 | 3170.4 (2656.6–3783.6) | 179 | 786.9 (595.2–1040.5) | 179 | 827.6 (610.1–1122.5) | |
| Study . | Age Category Prior to Immunization . | Preimmunizationa . | 28 d Postimmunizationb . | 1 Year Postimmunizationc . | 2 Years Postimmunizationd . | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | No. . | GMT (95% CI) . | ||
| Study A | 12–23 mo | 201 | 14.3 (9.9–20.7) | 198 | 6234.5 (4947.9–7855.7) | 65 | 1035.0 (678.4–1578.9) | 64 | 1313.7 (875.1–1971.9) |
| 22–33 mo | 63 | 42.6 (20.3–89.4) | 58 | 9342.9 (7043.8–12 392.4) | 56 | 2527.6 (1796.9–3555.5) | |||
| Study B | 2–10 y | 202 | 209.8 (144.4–304.7) | 203 | 6743.2 (5900.7–7705.9) | 202 | 3485.9 (3086.4–3937.2) | ||
| 11–17 y | 202 | 264.9 (187.7–374.0) | 202 | 4618.7 (4029.4–5294.2) | 196 | 3075.8 (2641.6–3581.3) | |||
| 18–29 y | 199 | 199.9 (138.5–288.6) | 198 | 3331.6 (2872.3–3864.4) | 186 | 2206.5 (1837.6–2649.4) | |||
| Study C | 14–18 wk | 191 | 2.2 (2.1–2.2) | 189 | 1138.9 (866.3–1497.3) | ||||
| 9–12 mo | 186 | 3.2 (2.5–3.9) | 180 | 2776.2 (2290.7–3364.6) | 175 | 365.6 (259.2–515.8) | 170 | 481.6 (344.9–672.5) | |
| 12–18 mo | 187 | 7.8 (5.4–11.3) | 184 | 3170.4 (2656.6–3783.6) | 179 | 786.9 (595.2–1040.5) | 179 | 827.6 (610.1–1122.5) | |
Except for the preimmunization comparisons, the rest of the comparisons were using mixed-effect models. The outcome variables were log2-transformed titers. Age category prior to immunization and time (visit points) were the main fixed effects in the models. Study subject was the random effect. The baseline titer, sex, and interaction effects of baseline titer-by-age category, sex-by-age category, baseline titer-by-time, and time-by-age category were also included in the models.
Abbreviations: CI, confidence interval; GMT, geometric mean titer.
a Prior to immunization with PsA-TT: P = .0059 for the comparison of SBA GMTs between subjects vaccinated at 12–23 months and 22–33 months of age in study A using t test; P < .0001 for the comparisons between subjects vaccinated at 14–18 weeks and 12–18 months of age and between subjects vaccinated at 9–12 months and 12–18 months of age; and P = .0315 for the comparison between subjects vaccinated at 14–18 weeks and 9–12 months of age in study C using analysis of variance.
b At 28 days postimmunization with PsA-TT: P = .0003 for the comparison of SBA GMTs between subjects vaccinated at 2–10 years and 11–17 years of age, P < .0001 for the comparison between subjects vaccinated at 2–10 years and 18–29 years of age, P = .0023 for comparison between subjects vaccinated at 11–17 years and 18–29 years of age in study B; P < .0001 for the comparison between subjects vaccinated at 14–18 weeks and 9–12 months of age and between 14–18 weeks and 12–18 months of age in study C.
c One year postimmunization with PsA-TT: P = .0022 for the comparison of SBA GMTs between subjects vaccinated at 12–23 months and 22–33 months of age in study A; P < .0001 for the comparison between subjects vaccinated at 2–10 years and 18–29 years of age and P = .0038 for the comparison between subjects vaccinated at 11–17 years and 18–29 years of age in study B; P = .0026 for the comparison between subjects vaccinated at 9–12 months and 12–18 months of age in study C.
d Two years postimmunization with PsA-TT: P = .0282 for the comparison of SBA GMTs between subjects vaccinated at 9–12 months and 12–18 months of age in study C.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
