Vaccine Information: VAXELIS (Page 3 of 4)

14.2 Immunogenicity

In the US Study 005 (Table 1), infants were randomized to receive 3 doses of VAXELIS at 2, 4, and 6 months of age and DAPTACEL and PedvaxHIB at 15 months of age, or Control group vaccines (3 doses of Pentacel vaccine at 2, 4, and 6 months of age + RECOMBIVAX HB at 2 and 6 months of age and DAPTACEL and ActHIB at 15 months of age). All subjects received concomitant vaccines: RotaTeq at 2, 4 and 6 months and Prevnar 13 at 2, 4, 6, and 15 months of age. [See ADVERSE REACTIONS (6.1).] All infants had received a dose of hepatitis B vaccine prior to study initiation, prior to or at one month of age. Among all randomized participants, 53.0% were male and 47.0% were female. Most (79.2%) participants were White, 14.1% were Black and 5.2% were multi-racial. Most (91.4%) participants were of non-Hispanic or non-Latin ethnicity.

Antibody responses to diphtheria, tetanus, pertussis (PT, FHA, PRN and FIM), poliovirus types 1, 2 and 3, hepatitis B and H. influenzae type b antigens were measured in sera obtained one month following the third dose of VAXELIS or Pentacel + RECOMBIVAX HB vaccines. VAXELIS was non-inferior to Pentacel + RECOMBIVAX HB administered concomitantly at separate sites, as demonstrated by the proportions of participants achieving seroprotective levels of antibodies to diphtheria, tetanus, poliovirus, hepatitis B and PRP antigens, and pertussis vaccine response rates and GMCs (except FHA), following 3 doses of the vaccine. See Table 3.

To complete the 4-dose pertussis primary vaccination series, participants in both groups received DAPTACEL at 15 months of age and were evaluated for immune responses to pertussis antigens one month later. The non-inferiority criteria for vaccine response rates and GMCs for all pertussis antigens were met following the fourth dose.

Table 3: Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines Administered Concomitantly with Prevnar 13 and RotaTeq in Study 005
VAXELIS + Prevnar 13 + RotaTeq(N=688 – 810) Pentacel + RECOMBIVAX HB + Prevnar 13 + RotaTeq(N=353 – 400)
N = The number of participants with available data.
*
Non-inferiority criterion met (lower bound of 2-sided 95% CI for the difference [VAXELIS group minus Control vaccines group] was >-10%).
Non-inferiority criterion met (lower bound of 2-sided 95% CI for the difference [VAXELIS group minus Control vaccines group] was >-5%).
Vaccine response = if pre-vaccination antibody concentration was <4 × lower limit of quantitation [LLOQ], then the post-vaccination antibody concentration was ≥4 × LLOQ; if pre-vaccination antibody concentration was ≥4 × LLOQ, then the post-vaccination antibody concentration was ≥pre-vaccination levels (pre-Dose 1).
§
Non-inferiority criterion met (lower bound of 2-sided 95% CI for the GMC ratio [VAXELIS group/Control vaccines group] was >0.67).
Non-inferiority criterion not met for anti-FHA GMC (lower bound of 2-sided 95% CI for the GMC ratio [VAXELIS group/Control vaccines group was 0.59 which is below the non-inferiority criterion >0.67).
Anti-Diphtheria Toxoid
% ≥0.1 IU/mL 82.4* 86.3
Anti-Tetanus Toxoid
% ≥0.1 IU/mL 99.9 99.5
Anti-PT
% vaccine response 98.1* 98.5
GMC 109.6§ 85.4
Anti-FHA
% vaccine response 87.3* 92.0
GMC 46.6 72.3
Anti-PRN
% vaccine response 79.3* 82.0
GMC 55.8§ 66.8
Anti-FIM
% vaccine response 90.2* 86.2
GMC 235.9§ 184.4
Anti-Poliovirus Type 1
% ≥1:8 dilution 100.0 98.2
Anti-Poliovirus Type 2
% ≥1:8 dilution 100.0 99.7
Anti-Poliovirus Type 3
% ≥1:8 dilution 100.0 99.8
Anti-PRP
% ≥0.15 μg/mL 97.3 92.4
% ≥1.0 μg/mL 85.0* 75.3
Anti-HBsAg
% ≥10 mIU/mL 99.4* 98.6

Study 006 (Table 1) was a lot consistency study conducted in the US, where infants were randomized to receive 3 doses of VAXELIS at 2, 4, and 6 months of age and Pentacel at 15 months of age (N=2,406), or control group vaccines (4 doses of Pentacel at 2, 4, 6, and 15 months of age + RECOMBIVAX HB at 2 and 6 months of age; N=402). All subjects received concomitant vaccines: RotaTeq at 2, 4 and 6 months and Prevnar 13 at 2, 4, 6, and 15 months of age. All infants had received a dose of hepatitis B vaccine prior to study initiation, from birth up to one month of age.

Antibody responses to diphtheria, tetanus, pertussis (PT, FHA, PRN and FIM), poliovirus types 1, 2 and 3, hepatitis B and H. influenzae type b antigens were measured in sera obtained one month following the third dose of VAXELIS or Pentacel + RECOMBIVAX HB. VAXELIS was non-inferior to Pentacel + RECOMBIVAX HB administered concomitantly at separate sites, as demonstrated by the proportions of participants achieving seroprotective levels of antibodies to diphtheria, tetanus, poliovirus, hepatitis B and PRP antigens, and pertussis vaccine response rates and GMCs, except for GMCs for FHA (lower bound of 2-sided 95% CI for GMC ratio [VAXELIS group/Control group vaccines] was 0.62, which was below the non-inferiority criterion >0.67).

To complete the 4-dose pertussis primary vaccination series, participants in both groups received Pentacel at 15 months of age and were evaluated for immune responses to pertussis antigens one month later. The non-inferiority criteria for antibody vaccine response rates and GMCs for all pertussis antigens were met following the fourth dose except for GMCs for PRN (lower bound of 2-sided 95% CI for GMC ratio [VAXELIS group/Control group vaccines] was 0.66, which was below the non-inferiority criterion >0.67).

14.3 Concomitantly Administered Vaccines

In Study 006 conducted in the US (Table 1), the immune responses to Prevnar 13 were measured one month after the third dose. Non-inferiority criteria were met for GMCs to 12 of the 13 serotype antigens in Prevnar 13 for participants who received VAXELIS relative to Control vaccines. For serotype 6B, the non-inferiority criterion was not met (lower bound of 2-sided 95% CI for GMC ratio [VAXELIS group/Control vaccines group] is 0.64, which is below the non-inferiority criterion >0.67).

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