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).

Table 12: Serotype-Specific OPA GMTs in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older (Study 1)
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.
*
GMTs, GMT ratio, and 95% CI are estimated from a cLDA model.
Non-inferiority for the 13 shared serotypes was met if the lower bound of the 95% CI for the GMT ratio (VAXNEUVANCE/Prevnar 13) was > 0.5.
Statistically significantly greater OPA GMT for serotype 3 was based on the lower bound of the 95% CI for the estimated GMT ratio (VAXNEUVANCE/Prevnar 13) > 1.2.
§
Statistically significantly greater OPA GMTs for serotypes 22F and 33F was based on the lower bound of the 95% CI for the estimated GMT ratio (VAXNEUVANCE/Prevnar 13) > 2.0.
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.

Table 13: Serotype-Specific OPA GMTs in Pneumococcal Vaccine-Naïve Adults 18 through 49 Years of Age With or Without Risk Factors for Pneumococcal Disease (Study 4)
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.
*
The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
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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