Vaccine Information: BOOSTRIX (Page 4 of 5)

14.3 Immunological Evaluation in Adults (Aged 19 to 64 Years)

A multicenter, randomized, observer-blinded study, conducted in the United States, evaluated the immunogenicity of BOOSTRIX compared with the licensed comparator Tdap vaccine (Sanofi Pasteur). Vaccines were administered as a single dose to subjects (N = 2,284) who had not received a tetanus-diphtheria booster within 5 years. The immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after administration. Approximately 33% of patients were aged 19 to 29 years, 33% were aged 30 to 49 years, and 34% were aged 50 to 64 years. Among subjects in the combined vaccine groups, 62% were female; 84% of subjects were white, 8% black, 1% Asian, and 7% were of other racial/ethnic groups.

Response to Tetanus and Diphtheria Toxoids

The antibody responses to the tetanus and diphtheria toxoids of BOOSTRIX compared with the comparator Tdap vaccine are shown in Table 9. One month after a single dose, anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between BOOSTRIX and the comparator Tdap vaccine.

Table 9. Antibody Responses to Tetanus and Diphtheria Toxoids following 1 Dose of BOOSTRIX Compared with the Comparator Tdap Vaccine in Adults Aged 19 to 64 Years (ATP Cohort for Immunogenicity)
Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed manufactured by Sanofi Pasteur.ATP = According-to-protocol; CI = Confidence Interval.a Measured by ELISA.b Seroprotection rates for BOOSTRIX were non-inferior to the comparator Tdap vaccine (lower limit of 95% CI on the difference of BOOSTRIX minus Tdap ≥-10%).c Non-inferiority criteria not prospectively defined for this endpoint.

Antibodies

n

% ≥0.1 IU/mLa

(95% CI)

% ≥1.0 IU/mLa

(95% CI)

Anti-tetanus

BOOSTRIX

1,445-1,447

Pre-vaccination

95.9 (94.8, 96.9)

71.9 (69.5, 74.2)

Post-vaccination

99.6 (99.1, 99.8)b

98.3 (97.5, 98.9)b

Tdap

727-728

Pre-vaccination

97.2 (95.8, 98.3)

74.7 (71.4, 77.8)

Post-vaccination

100 (95.5, 100)

99.3 (98.4, 99.8)

Anti-diphtheria

BOOSTRIX

1,440-1,444

Pre-vaccination

85.2 (83.3, 87.0)

23.7 (21.5, 26.0)

Post-vaccination

98.2 (97.4, 98.8)b

87.9 (86.1, 89.5)c

Tdap

720-727

Pre-vaccination

89.2 (86.7, 91.3)

26.5 (23.3, 29.9)

Post-vaccination

98.6 (97.5, 99.3)

92.0 (89.8, 93.9)

Response to Pertussis Antigens

Booster response rates to the pertussis antigens are shown in Table 10. For the FHA and PRN antigens, the lower limit of the 95% CI for the booster responses exceeded the pre-defined limit of 80% demonstrating an acceptable booster response following BOOSTRIX. The PT antigen booster response lower limit of the 95% CI (74.9%) did not exceed the pre-defined limit of 80%.

Table 10. Booster Responses to the Pertussis Antigens following 1 Dose of BOOSTRIX in Adults Aged 19 to 64 Years (ATP Cohort for Immunogenicity)
ATP = According-to-protocol; CI = Confidence Interval; PT = Pertussis toxin; FHA = Filamentous hemagglutinin; PRN = Pertactin.a Booster response: In initially seronegative subjects (<5 EL.U./mL), post-vaccination antibody concentrations ≥20 EL.U./mL. In initially seropositive subjects with pre-vaccination antibody concentrations ≥5 EL.U./mL and <20 EL.U./mL, an increase of at least 4 times the pre-vaccination antibody concentration. In initially seropositive subjects with pre-vaccination antibody concentrations ≥20 EL.U./mL, an increase of at least 2 times the pre-vaccination antibody concentration.b The PT antigen booster response lower limit of the 95% CI did not exceed the pre-defined limit of 80%.c The FHA and PRN antigens booster response lower limit of the 95% CI exceeded the pre-defined limit of 80%.

Pertussis Antibodies

n

BOOSTRIX

% Booster Responsea

(95% CI)

Anti-PT

1,419

77.2 (74.9, 79.3)b

Anti-FHA

1,433

96.9 (95.8, 97.7)c

Anti-PRN

1,441

93.2 (91.8, 94.4)c

The GMCs to each of the pertussis antigens 1 month following a single dose of BOOSTRIX in the U.S. adult (aged 19 to 64 years) study were compared with the GMCs observed in infants following a 3-dose primary series of INFANRIX administered at 3, 4, and 5 months of age. Table 11 presents the results for the total immunogenicity cohort in both studies (vaccinated subjects with serology data available for at least 1 pertussis antigen). These infants were a subset of those who formed the cohort for the German household contact study in which the efficacy of INFANRIX was demonstrated [see Clinical Studies (14.1)]. Although a serologic correlate of protection for pertussis has not been established, anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in adults 1 month after a single dose of BOOSTRIX were non-inferior to those observed in infants following a primary vaccination series with INFANRIX.

Table 11. Ratio of GMCs to Pertussis Antigens following 1 Dose of BOOSTRIX in Adults Aged 19 to 64 Years Compared with 3 Doses of INFANRIX in Infants (Total Immunogenicity Cohort)
GMC = Geometric mean antibody concentration; CI = Confidence Interval; PT = Pertussis toxin; FHA = Filamentous hemagglutinin; PRN = Pertactin.Number of subjects for GMC evaluation for BOOSTRIX: Anti-PT = 1,460, anti-FHA = 1,472, and anti-PRN = 1,473.Number of subjects for GMC evaluation for INFANRIX: Anti-PT = 2,884, anti-FHA = 685, and anti-PRN = 631.a BOOSTRIX was non-inferior to INFANRIX (lower limit of 95% CI for the GMC ratio of BOOSTRIX/INFANRIX ≥0.67).

Pertussis Antibodies

GMC Ratio: BOOSTRIX/INFANRIX

(95% CI)

Anti-PT

1.39 (1.32, 1.47)a

Anti-FHA

7.46 (6.86, 8.12)a

Anti-PRN

3.56 (3.10, 4.08)a

14.4 Immunological Evaluation in the Elderly (Aged 65 Years and Older)

The U.S. elderly (aged 65 years and older) study, a randomized, observer-blinded study, evaluated the immunogenicity of BOOSTRIX (n = 887) compared with a U.S.-licensed comparator Td vaccine (n = 445) (Sanofi Pasteur). Vaccines were administered as a single dose to subjects who had not received a tetanus-diphtheria booster within 5 years. Among all vaccine recipients, the mean age was approximately 72 years; 54% were female and 95% were white. The immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after administration.

Response to Tetanus and Diphtheria Toxoids and Pertussis Antigens

Immune responses to tetanus and diphtheria toxoids and pertussis antigens were measured 1 month after administration of a single dose of BOOSTRIX or a comparator Td vaccine. Anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL) were comparable between BOOSTRIX and the comparator Td vaccine (Table 12).

Table 12. Immune Responses to Tetanus and Diphtheria Toxoids following BOOSTRIX or Comparator Td Vaccine in the Elderly Aged 65 Years and Older (ATP Cohort for Immunogenicity)
Td = Tetanus and Diphtheria Toxoids Adsorbed, a U.S.-licensed Td vaccine, manufactured by Sanofi Pasteur.ATP = According-to-protocol; CI = Confidence Interval.a Seroprotection rates for BOOSTRIX were non-inferior to the comparator Td vaccine (lower limit of 95% CI on the difference of BOOSTRIX minus Td ≥-10%).b Non-inferiority criteria not prospectively defined for this endpoint.

Anti-Tetanus and Anti-Diphtheria Titers

BOOSTRIX

Td

(n = 844-864)

(n = 430-439)

Anti-tetanus

% ≥0.1 IU/mL (95% CI)

96.8 (95.4, 97.8)a

97.5 (95.6, 98.7)

% ≥1.0 IU/mL (95% CI)

88.8 (86.5, 90.8)a

90.0 (86.8, 92.6)

Anti-diphtheria

% ≥0.1 IU/mL (95% CI)

84.9 (82.3, 87.2)a

86.6 (83.0, 89.6)

% ≥1.0 IU/mL (95% CI)

52.0 (48.6, 55.4)b

51.2 (46.3, 56.0)

The GMCs to each of the pertussis antigens 1 month following a single dose of BOOSTRIX were compared with the GMCs of infants following a 3-dose primary series of INFANRIX administered at 3, 4, and 5 months of age. Table 13 presents the results for the total immunogenicity cohort in both studies (vaccinated subjects with serology data available for at least 1 pertussis antigen). These infants were a subset of those who formed the cohort for the German household contact study in which the efficacy of INFANRIX was demonstrated [see Clinical Studies (14.1)]. Although a serologic correlate of protection for pertussis has not been established, anti-PT, anti-FHA, and anti-PRN antibody concentrations in the elderly (aged 65 years and older) 1 month after a single dose of BOOSTRIX were non-inferior to those of infants following a primary vaccination series with INFANRIX.

Table 13. Ratio of GMCs to Pertussis Antigens following 1 Dose of BOOSTRIX in the Elderly Aged 65 Years and Older Compared with 3 Doses of INFANRIX in Infants (Total Immunogenicity Cohort)
GMC = Geometric mean antibody concentration; CI = Confidence Interval; PT = Pertussis toxin; FHA = Filamentous hemagglutinin; PRN = Pertactin.Number of subjects for GMC evaluation for BOOSTRIX: Anti-PT = 865, anti-FHA = 847, and anti-PRN = 878.Number of subjects for GMC evaluation for INFANRIX: Anti-PT = 2,884, anti-FHA = 685, and anti-PRN = 631.a BOOSTRIX was non-inferior to INFANRIX (lower limit of 95% CI for the GMC ratio of BOOSTRIX/INFANRIX ≥0.67).

Pertussis Antibodies

GMC Ratio: BOOSTRIX/INFANRIX

(95% CI)

Anti-PT

1.07 (1.00, 1.15)a

Anti-FHA

8.24 (7.45, 9.12)a

Anti-PRN

0.93 (0.79, 1.10)a

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