Table 2.
Studies evaluating immunogenicity of 13-valent conjugate pneumococcal vaccine (PCV13) in adults in sequential dosing.
| Study Name | Age group | Sequential Dosing Interval | PCV13/PCV13 (N)1 | PCV13/PPV23 (N)1 | PCV13PPV23 PCV13 (N)1 | PPV23/PCV13 (N)1 | Immunogenicity |
|---|---|---|---|---|---|---|---|
| Jackson 2013b [27] | ≥70 years | 1 year | At 1 yr: N=391 (372) |
- | - | At 1 yr: N=404 (373) |
1. PCV13/PCV13 had statistically significantly higher OPA titers in 3/13 serotypes (6A, 6B, 23F) compared to PCV13 alone. 2. PCV13/PCV13 had statistically significantly higher OPA titers in 10/13 serotypes (1,4,5,6A,6B,9V,18C,19A,19F,23F) compared to PPV23 alone. 3. PCV13/PCV13 had statistically significantly higher OPA titers in 12/13 serotypes (1,3,4,5,6A, 6B,7F,9V,19A, 19F, 23F) compared to sequential dose of PPV23/PCV13. 4. PPV23/PCV13 OPA titers did not differ statistically compared to PCV13 alone. |
| Jackson 2013c [28] | 50-64 years | 4 years | For 60-64 yrs: N=108 For 50-59 yrs: N=214 (211) |
For 60-64 yrs: N=108 |
For 60-64-year age group: 1. PCV13/PPV23 had statistically significantly higher OPA titers in 10/13 serotypes (1,3,5,6A,6B,7F,18C,19A,23F) compared to PPV23 alone. 2. PCV13/PPV23 had statistically significantly higher OPA titers in 8 serotypes (1,3,5,9V,18C,19A,19F) compared to PCV13 alone. 3. PCV13/PCV13 had statistically significantly higher OPA titers in 7/13 serotypes (1,4,6A,6B,7F,9V,18C,19A,23F) compared to PCV13 alone. For 50-59-year-old age group: 1. PCV13/PCV13 had statistically significantly higher OPA titers in 6/13 (1,4,6A,6B,7F,9V,18C,19A,23F) compared to PCV13 alone. 2. PCV13/PCV13 had statistically significantly higher OPA titers in 5/13 serotypes (4,6A,7F,9V,19A) compared to PCV13/PCV13 in 60-64-year age group. |
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| Greenberg 2014 [29] | 60-64 years | 1 year | 160 (133) | 267 (237) | - | 223 (199) | 1. PCV13/PPV23 had a statistically significantly higher OPA titers in 7/13 serotypes (3,5,6A, 6B,7F,19F,23F) compared to PPV23 alone. 2. PCV13/PPV23 had a statistically significantly higher OPA titers in 11/13 serotypes (1,3,4,5,6B,7F,9V, 18C,19A,19F,23F) compared to PPV23/PCV13. 3. PCV13/PCV13 had a statistically significantly higher OPA titers in 6/13 serotypes (1,3,6A, 6B,7F,9V) compared to PPV23/PCV13. 4. PCV13/PCV13 had a statistically significantly higher OPA titers in 1/13 serotypes (23F) compared to PCV13 alone. 5. PCV13/PPV23 had a statistically significantly higher OPA titers in 1/13 serotypes (3) compared to PCV13 alone. 6. PPV23/PCV13 OPA titers did not differ statistically compared to PCV13 alone. |
| Juergens 2014 [30] | ≥65 years | 1 year | At 1 yr: N=136 |
At 1 yr: N=131 |
At 2 yr: N=104 |
- | 1. PCV13/PPV23 had a statistically significantly higher OPA titers in 8/13 serotypes (1,3,5,6A, 6B,9V,19F,23F) compared to PPV23 alone. 2. PCV13/PPV23/PCV13 had a statistically significantly higher OPA titers in 3/13 serotypes (6A, 6B,23F) compared to PCV13/PPV23. 3. PCV13/PCV13 had a statistically significantly higher OPA titers in 1/13 serotypes (23F) compared to PCV13 alone. 4. PCV13/PPV23/PCV13 OPA titers did not differ statistically compared to PCV13 alone. |
Abbreviations: PCV13 - 13 valent conjugate pneumococcal vaccine; PPV23 - 23 valent pneumococcal polysaccharide vaccine; PLB- Placebo
1
N is for all randomized subjects and those included in the immunogenicity analyses are included in brackets if they differed from original.
2
All OPA GMT ratios are reported at 1 month after vaccination