Vaccine Information: VAXNEUVANCE (Page 3 of 4)
14.2 Clinical Trials in Pneumococcal Vaccine-Naïve Adults
Study 1
Study 1 assessed serotype-specific opsonophagocytic activity (OPA) responses for each of the 15 serotypes contained in VAXNEUVANCE at 30 days postvaccination in a double-blind, active comparator-controlled study that enrolled pneumococcal vaccine-naïve participants 50 years of age and older. Participants were randomized to receive either VAXNEUVANCE (N=604) or Prevnar 13 (N=601) at sites in USA, Canada, Spain, Taiwan, and Japan. The mean age of participants was 66 years and 57.3% were female. The racial distribution was as follows: 67.7% were White, 25.1% were Asian, 6.1% were Black or African American and 22.0% were of Hispanic or Latino ethnicity.
Table 12 summarizes the OPA geometric mean antibody titers (GMTs) at 30 days postvaccination for the 15 serotypes contained in VAXNEUVANCE. The study demonstrated that VAXNEUVANCE is noninferior to Prevnar 13 for the 13 shared serotypes and induces statistically significantly greater OPA GMTs compared to Prevnar 13 for shared serotype 3 and for the 2 unique serotypes (22F, 33F).
PneumococcalSerotype | VAXNEUVANCE(N = 602) | Prevnar 13(N = 600) | GMT Ratio *(VAXNEUVANCE/Prevnar 13)(95% CI)* | ||
---|---|---|---|---|---|
n | GMT * | n | GMT * | ||
N=Number of participants randomized and vaccinated; n=Number of participants contributing to the analysis that had at least one pre-dose OPA measurement (VAXNEUVANCE, n=537-597; Prevnar 13, n=545-595) or post-dose OPA measurement (VAXNEUVANCE, n=568-580; Prevnar 13, n=528-574).CI=confidence interval; cLDA=constrained longitudinal data analysis; GMT=geometric mean titer; OPA=opsonophagocytic activity. | |||||
| |||||
Serotype † | |||||
1 | 598 | 257 | 598 | 321 | 0.80 (0.66, 0.97) |
3‡ | 598 | 215 | 598 | 133 | 1.62 (1.40, 1.87) |
4 | 598 | 1109 | 598 | 1633 | 0.68 (0.57, 0.80) |
5 | 598 | 445 | 598 | 560 | 0.79 (0.64, 0.98) |
6A | 596 | 5371 | 596 | 5276 | 1.02 (0.85, 1.22) |
6B | 598 | 3984 | 598 | 3179 | 1.25 (1.04, 1.51) |
7F | 596 | 4575 | 596 | 5830 | 0.78 (0.68, 0.90) |
9V | 598 | 1809 | 597 | 2193 | 0.83 (0.71, 0.96) |
14 | 598 | 1976 | 598 | 2619 | 0.75 (0.64, 0.89) |
18C | 598 | 2749 | 598 | 2552 | 1.08 (0.91, 1.27) |
19A | 598 | 3177 | 597 | 3921 | 0.81 (0.70, 0.94) |
19F | 598 | 1688 | 598 | 1884 | 0.90 (0.77, 1.04) |
23F | 598 | 2029 | 598 | 1723 | 1.18 (0.96, 1.44) |
Additional Serotypes § | |||||
22F | 594 | 2381 | 585 | 73 | 32.52 (25.87, 40.88) |
33F | 598 | 8010 | 597 | 1114 | 7.19 (6.13, 8.43) |
Study 3
In a double-blind, active comparator-controlled, descriptive study (Study 3), pneumococcal vaccine-naïve adults 50 years of age and older were randomized to receive either VAXNEUVANCE (N=327) or Prevnar 13 (N=325), followed by PNEUMOVAX 23 one year later.
Following vaccination with PNEUMOVAX 23, OPA GMTs were numerically similar between the two vaccination groups for the 15 serotypes in VAXNEUVANCE.
Study 4
In a double-blind, descriptive study (Study 4), adults 18 through 49 years of age, including individuals with increased risk of developing pneumococcal disease, were randomized to receive VAXNEUVANCE (N=1,135) or Prevnar 13 (N=380), followed by PNEUMOVAX 23 six months later [see Adverse Reactions (6.1)]. Among those who received VAXNEUVANCE, 620 participants had one risk factor and 228 participants had two or more risk factors for pneumococcal disease.
Table 13 presents OPA GMTs in the overall study population for each of the 15 serotypes 30 days following vaccination with VAXNEUVANCE or Prevnar 13.
PneumococcalSerotype | VAXNEUVANCE(N = 1,133) | Prevnar 13(N = 379) | ||||
---|---|---|---|---|---|---|
n | Observed GMT | 95% CI * | n | Observed GMT | 95% CI * | |
N=Number of participants randomized and vaccinated; n=Number of participants contributing to the analysis. CI=confidence interval; GMT=geometric mean titer; OPA=opsonophagocytic activity. | ||||||
| ||||||
Serotype | ||||||
1 | 1004 | 267 | (242, 295) | 337 | 267 | (220, 324) |
3 | 990 | 198 | (184, 214) | 336 | 150 | (129, 173) |
4 | 1001 | 1401 | (1294, 1517) | 338 | 2568 | (2268, 2908) |
5 | 1003 | 560 | (508, 618) | 339 | 731 | (613, 873) |
6A | 994 | 12763 | (11772, 13838) | 333 | 11313 | (9739, 13141) |
6B | 999 | 10164 | (9486, 10891) | 338 | 6958 | (5987, 8086) |
7F | 1004 | 5725 | (5382, 6090) | 338 | 7583 | (6762, 8503) |
9V | 1000 | 3353 | (3132, 3590) | 339 | 3969 | (3541, 4449) |
14 | 1001 | 5245 | (4860, 5660) | 339 | 5863 | (5191, 6623) |
18C | 999 | 5695 | (5314, 6103) | 339 | 3050 | (2685, 3465) |
19A | 1001 | 5335 | (4985, 5710) | 339 | 5884 | (5221, 6632) |
19F | 1003 | 3253 | (3051, 3468) | 339 | 3272 | (2949, 3631) |
23F | 1001 | 4828 | (4443, 5247) | 337 | 3876 | (3323, 4521) |
Additional Serotypes | ||||||
22F | 991 | 3939 | (3654, 4246) | 317 | 291 | (221, 383) |
33F | 999 | 11734 | (10917, 12612) | 334 | 2181 | (1826, 2606) |
Following vaccination with PNEUMOVAX 23, the OPA GMTs for the 15 serotypes in VAXNEUVANCE were numerically similar among subjects who had received VAXNEUVANCE or Prevnar 13 for the first vaccination.
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