Table 2.
Potential Differences in Immunogenicity Among Vaccines for Shared Serotypes in Key Phase 3 Randomized Controlled Clinical Trials
| Shared Serotypes Failing Noninferiority Criteria With Higher-Valency PCV | |||||
|---|---|---|---|---|---|
| Author | PCVs | Vaccination Schedule, mo | Timing of Assessment | Response Ratea | IgG GMC Ratiob |
| Vesikari (2009) [21] | PCV7 | 2, 3, 4 | 1 mo after primary series | 6B, 23Fc,d | NR |
| PCV10 | +12–18 | ||||
| Kieninger (2010) [22] | PCV7 | 2, 3, 4 | 1 mo after primary series | 6B | None |
| PCV13 | +11–12 | ||||
| Yeh (2010) [23] | PCV7 | 2, 4, 6 | 1 mo after primary series | 6B, 9V | None |
| PCV13 | +12–15 | ||||
| Temple (2019) [1] | PCV10 | 2, 4 | 1 mo after primary series | Noned | NR |
| PCV13 | +9.5 | ||||
| Lupinacci (2023) [24] | PCV13 | 2, 4, 6 | 1 mo after primary series | Noned | 6Ad |
| V114 | +12–15 | ||||
| Benfield (2023) [25] | PCV13 | 3, 5 | 1 mo after toddler dose | Noned | Noned |
| V114 | +12 | ||||
| Martinon-Torres (2023) [26] | PCV13 | 2, 4 | 1 mo after toddler dose | Noned | Noned |
| V114 | +11–15 | ||||
| Watson (2023) [27] | PCV13 | 2, 4, 6 | 1 mo after primary series | 1, 3, 4, 9V, 23Fd,e | None |
| PCV20 | +12–15 | 1 mo after toddler dose | NRd | Noned | |
Abbreviations: GMC, geometric mean concentration; IgG, immunoglobulin G; NR, not reported; PCV; pneumococcal conjugate vaccine; PCV7, 7-valent pneumococcal conjugate vaccine; PCV10, 10-valent pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PCV20, 20-valent pneumococcal conjugate vaccine; V114, 15-valent pneumococcal conjugate vaccine.
aIgG response threshold is 0.35 μg/mL unless otherwise stated.
bNoninferiority criteria differed across studies.
cIgG response threshold is 0.20 μg/mL for noninferiority; serotypes listed did not meet noninferiority criteria.
dPrimary or coprimary immunogenicity endpoint.
eDifferent thresholds used for serotypes 5, 6B, and 19A.