Vaccine Information: MenQuadfi (Page 3 of 4)

14.2 Booster Vaccination Following Priming with a Meningococcal Conjugate Vaccine; Vaccination Following a Prior Dose of a Meningococcal Polysaccharide Vaccine

Immunogenicity in Adolescents and Adults at least 15 Years of Age and Older

Immunogenicity of a booster dose of MenQuadfi compared to a booster dose of Menactra was evaluated in Study 5 (NCT02752906). The study-enrolled participants 15 years of age and older who had received a primary dose of Menveo or Menactra 4 to 10 years previously.

Immune non-inferiority, based on seroresponse rates, was demonstrated for MenQuadfi as compared to Menactra for all four serogroups.

For a description of study design and number of participants, see section 6.1 Booster Vaccination Following Priming with a Meningococcal Conjugate Vaccine; Vaccination Following a Prior Dose of a Meningococcal Polysaccharide Vaccine. The primary immunogenicity endpoint was hSBA seroresponse to each serogroup 30 days following booster vaccination with MenQuadfi or Menactra given to participants who received a prior dose of Menveo or Menactra 4 to 10 years ago. The other endpoints included the proportions of participants with post-vaccination hSBA ≥1:8 and the hSBA GMTs for each serogroup. These endpoints were also evaluated at 6 days post vaccination in a subset.

Seroresponse rates at Day 30 following booster vaccination with MenQuadfi were 92.2% for serogroup A, 97.1% for serogroup C, 98.2% for serogroup W, and 97.4% for serogroup Y, as compared to 87.1% for serogroup A, 91.8% for serogroup C, 90.7% for serogroup W, and 95.6% for serogroup Y, following booster vaccination with Menactra. At Day 6, following booster vaccination with MenQuadfi, seroresponse rates were 72.7%, 83.6%, 94.5%, and 90.9% for serogroups A, C, W, and Y, respectively.

The hSBA GMTs were 173, 334, 499, and 302 for serogroups A, C, W, and Y at Day 6, and 497, 2618, 1747, and 2070, respectively, for the 4 serogroups at Day 30 following booster dose of MenQuadfi.

Overall, similar seroresponse rates were observed for those participants who received booster vaccination with Menactra.

Immunogenicity in Adolescents and Adults 13 through 26 Years of Age

Immunogenicity of a booster dose of MenQuadfi was evaluated in Study 6 (NCT04084769). The study enrolled participants 13 through 26 years of age who had received a primary dose of MenQuadfi or Menveo 3–6 years previously in Study 2 or Study 3.

For a description of study design and number of participants, see section 6.1 Booster Vaccination Following Priming with a Meningococcal Conjugate Vaccine; Vaccination Following a Prior Dose of a Meningococcal Polysaccharide Vaccine. The primary immunogenicity endpoints were hSBA seroresponse to each serogroup 30 days following a booster vaccination with MenQuadfi given to participants who received a prior dose of MenQuadfi or Menveo 3–6 years previously (Table 11). The other endpoints included hSBA GMTs for each serogroup. These endpoints were also evaluated at 6 days post vaccination in a subset (Per-Protocol Analysis Set 1).

Table 11: Comparison of hSBA Seroresponse Rates 30 Days Following Booster Vaccination with MenQuadfi in Participants 13 through 26 Years of Age Primed with MenQuadfi or Menveo 3-6 Years Previously (Study 6)*
Endpoint by Serogroup MenQuadfi-primed(95% CI)N=174 Menveo-primed(95% CI)N=176
N: number of subjects in Per-Protocol Analysis Set 2 (D30) with valid serology results.
*
Clinical trial identifier NCT04084769
Seroresponse rate (primary endpoint) for each serogroup: the proportion of participants with an hSBA pre vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16, or pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer.Sufficiency of hSBA seroresponse after MenQuadfi vaccination was demonstrated if the lower limit of the 2-sided 95% CI was >75%.
A
% Participants achieving Seroresponse 94.8 (90.4; 97.6) 93.2 (88.4; 96.4)
C
% Participants achieving Seroresponse 97.1 (93.4; 99.1) 98.9 (96.0; 99.9)
W
% Participants achieving Seroresponse 97.7 (94.2; 99.4) 98.9 (96.0; 99.9)
Y
% Participants achieving Seroresponse 98.9 (95.9; 99.9) 100 (97.9; 100)

Seroresponse rates at Day 6 following booster dose with MenQuadfi were 82.6%, 89.1%, 97.8%, and 95.7% for serogroups A, C, W, and Y, respectively, in MenQuadfi-primed participants (N=46) and 77.8%, 93.3%, 88.9%, and 91.1% for serogroups A, C, W, and Y, respectively, in Menveo-primed participants (N=45).

Following a booster dose of MenQuadfi, the hSBA GMTs at Day 6 were 289, 3799, 1928, and 1658 for MenQuadfi-primed participants (N=46) and 161, 919, 708, and 800 for Menveo-primed participants (N=45) for serogroups A, C, W, and Y, respectively. At D30, the hSBA GMTs were 502, 3708, 2290, and 2308 for MenQuadfi-primed participants (N=174) and 399, 2533, 2574, and 3036 for Menveo-primed participants (N=176).

Prior to booster vaccination, the percentage of subjects with hSBA titers ≥1:8 for serogroups A, C, W, and Y were 71.3%, 87.9%, 86.2%, and 79.9% for those who received a prior dose of MenQuadfi 3-6 years earlier (N=174), and 71.0%, 50.6%, 77.8%, and 52.8% for those who received a prior dose of Menveo 3-6 years earlier (N=176).

Immunogenicity in Older Adults 59 Years of Age

Immunogenicity of a dose of MenQuadfi was evaluated in Study 7 (NCT04142242). The study enrolled participants 59 years of age who had received a prior dose of MenQuadfi or Menomune at least 3 years previously in Study 4 (NCT02842866).

For a description of study design and number of participants, see section 6.1 Booster Vaccination Following Priming with a Meningococcal Conjugate Vaccine; Vaccination Following a Prior Dose of a Meningococcal Polysaccharide Vaccine. The primary immunogenicity endpoint was hSBA seroresponse to each serogroup 30 days following vaccination with MenQuadfi in participants who had received a prior dose of Menomune 3 years previously. Additionally, hSBA seroresponse 30 days following vaccination with MenQuadfi in MenQuadfi-primed participants was also assessed (Table 12). The other endpoints included the hSBA GMTs for each serogroup. These endpoints were also evaluated at 6 days post vaccination in a subset (Per-Protocol Analysis Set 2).

Table 12: Comparison of hSBA Seroresponse Rates 30 Days Following Vaccination with MenQuadfi in Participants ≥ 59 Years of Age Primed with MenQuadfi or Received a Prior Dose of Menomune At Least 3 Years Previously (Study 7)*
Endpoint by Serogroup MenQuadfi- primed(95% CI) Prior dose of Menomune(95% CI)
N: number of subjects in Per-Protocol Analysis Set 1 (D30) with valid serology results.
*
Clinical trial identifier NCT04142242
Seroresponse rate (primary endpoint) for each serogroup: the proportion of participants with an hSBA pre vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16, or pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer.Sufficiency of hSBA seroresponse after MenQuadfi vaccination was demonstrated if the lower limit of the 2-sided 95% CI was >40%.
A N=145 N=130
% Participants achieving Seroresponse 79.3 (71.8; 85.6) 60.8 (51.8; 69.2)
C
% Participants achieving Seroresponse 93.1 (87.7; 96.6) 55.0 (46.0; 63.8)
W
% Participants achieving Seroresponse 90.3 (84.3; 94.6) 49.2 (40.4; 58.1)
Y
% Participants achieving Seroresponse 92.4 (86.8; 96.2) 49.2 (40.4; 58.1)

Seroresponse rates at Day 6 following vaccination with MenQuadfi were 36.2%, 77.6%, 70.7%, and 72.4% for serogroups A, C, W, and Y, respectively, in MenQuadfi-primed participants (N=58) and 8.1%, 8.1%, 6.5%, and 8.1% for serogroups A, C, W, and Y, respectively, in participants who received a prior dose of Menomune (N=62). Following vaccination with MenQuadfi, the hSBA GMTs at Day 6 were 44, 206, 118, and 151 for MenQuadfi-primed participants (N=58) and 13, 11, 10, and 11 for participants who received a prior dose of Menomune (N=62) for serogroups A, C, W, and Y, respectively. At D30, the hSBA GMTs were 162, 638, 419, and 566 for MenQuadfi-primed participants (N=145) and 57, 56, 31, and 41 for participants who received a prior dose of Menomune (N=130).

Prior to MenQuadfi vaccination, the percentage of subjects with hSBA titers ≥1:8 for serogroups A, C, W, and Y were 64.8%, 73.8%, 66.9%, and 72.4% for those who received a prior dose of MenQuadfi at least 3 years earlier (N=145), and 65.4%, 49.2%, 40.0%, and 41.5% for those who received a prior dose of Menomune at least 3 years earlier (N=130).

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