Summary of Vaccine Received, Time of Blood Sample, Follow-up Duration, and Demographics of Study Subjects
| Study . | Age Category Prior to Immunization . | Vaccine Receiveda . | Demographics Preimmunization With PsA-TT . | 28 d Postimmunization With PsA-TT . | 1 Year Postimmunization With PsA-TT . | 2 Years Postimmunization With PsA-TT . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No.b . | Median Age (Min-Max) . | Female, No. (%) . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | |||
| Study A | 12–23 mo | 1st vac: 10 µg of PsA-TT | 201 | 17 mo (11e–23) | 92 (45.8) | 201 | 28 d after 1st vac | 1.0 | 65 | 1 y after 1st vac | 14.1 | 64 | Two y after 1st vac | 25.7 |
| 2nd vac: Hib-TT | ||||||||||||||
| 22–33 mo | 1st vac: Hib-TT | 63 | 25 mo (20–32) | 27 (42.9) | 62 | 28 d after 2nd vac | 1.0 | 60 | Two years after 1st vac | 16.9 | ||||
| 2nd vac: 10 µg of PsA-TT | ||||||||||||||
| Study B | 2–10 y | 10 µg of PsA-TT | 203 | 7 y (2–10) | 101 (49.8) | 203 | 28 d after vac | 1.0 | 202 | 1 y after vac | 12.6 | |||
| 11–17 y | 10 µg of PsA-TT | 202 | 14 y (11–17) | 75 (37.1) | 202 | 28 d after vac | 1.0 | 196 | 1 y after vac | 12.5 | ||||
| 18–29 y | 10 µg of PsA-TT | 199 | 20 y (18–29) | 74 (37.2) | 198 | 28 d after vac | 1.0 | 187 | 1 y after vac | 12.5 | ||||
| Study C | 14–18 wk | 1st vac: 10 µg of PsA-TT, EPI | 200 | 14 wk (14–17) | 107 (53.5) | 200 | 28 d after 1st vac | 0.9 | ||||||
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 9–12 mo | 1st vac: EPI | 189 | 9 mo (8–12) | 94 (49.7) | 187 | 28 d after 2nd vac | 1.0 | 177 | 2 y of age | 15.3 | 171 | 3 y of age | 27.1 | |
| 2nd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 12–18 mo | 1st vac: EPI | 190 | 15 mo (12–19) | 97 (51.1) | 189 | 28 d after 3rd vac | 1.0 | 183 | 2 y of age | 9.6 | 181 | 3 y of age | 21.4 | |
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
| Study . | Age Category Prior to Immunization . | Vaccine Receiveda . | Demographics Preimmunization With PsA-TT . | 28 d Postimmunization With PsA-TT . | 1 Year Postimmunization With PsA-TT . | 2 Years Postimmunization With PsA-TT . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No.b . | Median Age (Min-Max) . | Female, No. (%) . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | |||
| Study A | 12–23 mo | 1st vac: 10 µg of PsA-TT | 201 | 17 mo (11e–23) | 92 (45.8) | 201 | 28 d after 1st vac | 1.0 | 65 | 1 y after 1st vac | 14.1 | 64 | Two y after 1st vac | 25.7 |
| 2nd vac: Hib-TT | ||||||||||||||
| 22–33 mo | 1st vac: Hib-TT | 63 | 25 mo (20–32) | 27 (42.9) | 62 | 28 d after 2nd vac | 1.0 | 60 | Two years after 1st vac | 16.9 | ||||
| 2nd vac: 10 µg of PsA-TT | ||||||||||||||
| Study B | 2–10 y | 10 µg of PsA-TT | 203 | 7 y (2–10) | 101 (49.8) | 203 | 28 d after vac | 1.0 | 202 | 1 y after vac | 12.6 | |||
| 11–17 y | 10 µg of PsA-TT | 202 | 14 y (11–17) | 75 (37.1) | 202 | 28 d after vac | 1.0 | 196 | 1 y after vac | 12.5 | ||||
| 18–29 y | 10 µg of PsA-TT | 199 | 20 y (18–29) | 74 (37.2) | 198 | 28 d after vac | 1.0 | 187 | 1 y after vac | 12.5 | ||||
| Study C | 14–18 wk | 1st vac: 10 µg of PsA-TT, EPI | 200 | 14 wk (14–17) | 107 (53.5) | 200 | 28 d after 1st vac | 0.9 | ||||||
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 9–12 mo | 1st vac: EPI | 189 | 9 mo (8–12) | 94 (49.7) | 187 | 28 d after 2nd vac | 1.0 | 177 | 2 y of age | 15.3 | 171 | 3 y of age | 27.1 | |
| 2nd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 12–18 mo | 1st vac: EPI | 190 | 15 mo (12–19) | 97 (51.1) | 189 | 28 d after 3rd vac | 1.0 | 183 | 2 y of age | 9.6 | 181 | 3 y of age | 21.4 | |
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
In study A, subjects received 2 vaccinations, one at 12–23 months and the other at 22–33 months of age; in study B, subjects received only 1 vaccination; in study C, subjects received 3 vaccinations, the first at 14–18 weeks, the second at 9–12 months, and the third at 12–18 months of age. The scheduled time of blood draw prior to immunization with PsA-TT in each study was immediately before the immunization.
Abbreviations: EPI, Expanded Programme on Vaccination; Hib-TT, Haemophilus influenzae type b–tetanus toxoid; PsA-TT, meningococcal A polysaccharide–tetanus toxoid protein conjugate vaccine; vac, vaccination.
a Vaccine received: the vaccine(s) that subjects who are included in the current study received.
b No.: the number of subjects available for blood draws at a particular time.
c Time of blood draw: the scheduled time of blood draw that was included in current study.
d Mean duration: the actual average follow-up time from vaccination with PsA-TT to blood draw.
e One subject was vaccinated 1 day before his 12-month birthday due to an initial typographical error in his date of birth.
Summary of Vaccine Received, Time of Blood Sample, Follow-up Duration, and Demographics of Study Subjects
| Study . | Age Category Prior to Immunization . | Vaccine Receiveda . | Demographics Preimmunization With PsA-TT . | 28 d Postimmunization With PsA-TT . | 1 Year Postimmunization With PsA-TT . | 2 Years Postimmunization With PsA-TT . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No.b . | Median Age (Min-Max) . | Female, No. (%) . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | |||
| Study A | 12–23 mo | 1st vac: 10 µg of PsA-TT | 201 | 17 mo (11e–23) | 92 (45.8) | 201 | 28 d after 1st vac | 1.0 | 65 | 1 y after 1st vac | 14.1 | 64 | Two y after 1st vac | 25.7 |
| 2nd vac: Hib-TT | ||||||||||||||
| 22–33 mo | 1st vac: Hib-TT | 63 | 25 mo (20–32) | 27 (42.9) | 62 | 28 d after 2nd vac | 1.0 | 60 | Two years after 1st vac | 16.9 | ||||
| 2nd vac: 10 µg of PsA-TT | ||||||||||||||
| Study B | 2–10 y | 10 µg of PsA-TT | 203 | 7 y (2–10) | 101 (49.8) | 203 | 28 d after vac | 1.0 | 202 | 1 y after vac | 12.6 | |||
| 11–17 y | 10 µg of PsA-TT | 202 | 14 y (11–17) | 75 (37.1) | 202 | 28 d after vac | 1.0 | 196 | 1 y after vac | 12.5 | ||||
| 18–29 y | 10 µg of PsA-TT | 199 | 20 y (18–29) | 74 (37.2) | 198 | 28 d after vac | 1.0 | 187 | 1 y after vac | 12.5 | ||||
| Study C | 14–18 wk | 1st vac: 10 µg of PsA-TT, EPI | 200 | 14 wk (14–17) | 107 (53.5) | 200 | 28 d after 1st vac | 0.9 | ||||||
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 9–12 mo | 1st vac: EPI | 189 | 9 mo (8–12) | 94 (49.7) | 187 | 28 d after 2nd vac | 1.0 | 177 | 2 y of age | 15.3 | 171 | 3 y of age | 27.1 | |
| 2nd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 12–18 mo | 1st vac: EPI | 190 | 15 mo (12–19) | 97 (51.1) | 189 | 28 d after 3rd vac | 1.0 | 183 | 2 y of age | 9.6 | 181 | 3 y of age | 21.4 | |
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
| Study . | Age Category Prior to Immunization . | Vaccine Receiveda . | Demographics Preimmunization With PsA-TT . | 28 d Postimmunization With PsA-TT . | 1 Year Postimmunization With PsA-TT . | 2 Years Postimmunization With PsA-TT . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No.b . | Median Age (Min-Max) . | Female, No. (%) . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | No.b . | Time of Blood Drawc . | Mean Duration, mod . | |||
| Study A | 12–23 mo | 1st vac: 10 µg of PsA-TT | 201 | 17 mo (11e–23) | 92 (45.8) | 201 | 28 d after 1st vac | 1.0 | 65 | 1 y after 1st vac | 14.1 | 64 | Two y after 1st vac | 25.7 |
| 2nd vac: Hib-TT | ||||||||||||||
| 22–33 mo | 1st vac: Hib-TT | 63 | 25 mo (20–32) | 27 (42.9) | 62 | 28 d after 2nd vac | 1.0 | 60 | Two years after 1st vac | 16.9 | ||||
| 2nd vac: 10 µg of PsA-TT | ||||||||||||||
| Study B | 2–10 y | 10 µg of PsA-TT | 203 | 7 y (2–10) | 101 (49.8) | 203 | 28 d after vac | 1.0 | 202 | 1 y after vac | 12.6 | |||
| 11–17 y | 10 µg of PsA-TT | 202 | 14 y (11–17) | 75 (37.1) | 202 | 28 d after vac | 1.0 | 196 | 1 y after vac | 12.5 | ||||
| 18–29 y | 10 µg of PsA-TT | 199 | 20 y (18–29) | 74 (37.2) | 198 | 28 d after vac | 1.0 | 187 | 1 y after vac | 12.5 | ||||
| Study C | 14–18 wk | 1st vac: 10 µg of PsA-TT, EPI | 200 | 14 wk (14–17) | 107 (53.5) | 200 | 28 d after 1st vac | 0.9 | ||||||
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 9–12 mo | 1st vac: EPI | 189 | 9 mo (8–12) | 94 (49.7) | 187 | 28 d after 2nd vac | 1.0 | 177 | 2 y of age | 15.3 | 171 | 3 y of age | 27.1 | |
| 2nd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
| 3rd vac: EPI | ||||||||||||||
| 12–18 mo | 1st vac: EPI | 190 | 15 mo (12–19) | 97 (51.1) | 189 | 28 d after 3rd vac | 1.0 | 183 | 2 y of age | 9.6 | 181 | 3 y of age | 21.4 | |
| 2nd vac: EPI | ||||||||||||||
| 3rd vac: 10 µg of PsA-TT, EPI | ||||||||||||||
In study A, subjects received 2 vaccinations, one at 12–23 months and the other at 22–33 months of age; in study B, subjects received only 1 vaccination; in study C, subjects received 3 vaccinations, the first at 14–18 weeks, the second at 9–12 months, and the third at 12–18 months of age. The scheduled time of blood draw prior to immunization with PsA-TT in each study was immediately before the immunization.
Abbreviations: EPI, Expanded Programme on Vaccination; Hib-TT, Haemophilus influenzae type b–tetanus toxoid; PsA-TT, meningococcal A polysaccharide–tetanus toxoid protein conjugate vaccine; vac, vaccination.
a Vaccine received: the vaccine(s) that subjects who are included in the current study received.
b No.: the number of subjects available for blood draws at a particular time.
c Time of blood draw: the scheduled time of blood draw that was included in current study.
d Mean duration: the actual average follow-up time from vaccination with PsA-TT to blood draw.
e One subject was vaccinated 1 day before his 12-month birthday due to an initial typographical error in his date of birth.
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