Vaccine Information: BOOSTRIX (Page 4 of 5)

14.3 Immunological Evaluation following Revaccination with BOOSTRIX

Adults (Aged 20 to 29 Years)

A multicenter, open-label, controlled study conducted in the United States evaluated the immunogenicity of BOOSTRIX in adults aged 20 to 29 years who received an initial dose of BOOSTRIX (n = 128) or the comparator Td vaccine (MassBiologics) (n = 37) in the U.S. adolescent (aged 10 to 18 years) study. BOOSTRIX was administered to all subjects 10 years after initial vaccination. The immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after vaccine administration. Among all vaccine recipients, the mean age was 23.5 years; 45.5% were female, and 87.9% were White.

Response to Tetanus and Diphtheria Toxoids: The antibody responses to the tetanus and diphtheria toxoids of BOOSTRIX are shown in Table 16. One month after vaccination, anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between groups.

Table 16. Antibody Responses to Tetanus and Diphtheria Toxoids following BOOSTRIX in Adults Aged 20 to 29 Years (ATP Cohort for Immunogenicity)
Td manufactured by MassBiologics.ATP = According-to-protocol; CI = Confidence Interval.n = Number of subjects with available results.a Measured by ELISA.b Subjects who were revaccinated with BOOSTRIX 10 years after initial vaccination with BOOSTRIX.c Seroprotection rates following revaccination with BOOSTRIX were non-inferior to an initial dose of BOOSTRIX (Td group) (lower limit of 2-sided 95% CI on the difference for second dose of BOOSTRIX minus first dose of BOOSTRIX ≥-10%).d Non-inferiority criteria not prospectively defined for this endpoint.e Subjects who received a dose of BOOSTRIX 10 years after initial vaccination with Td vaccine.

% ≥0.1 IU/mLa

% ≥1.0 IU/mLa

Antibodies

n

(95% CI)

(95% CI)

Anti-tetanus

BOOSTRIXb

115

Pre-vaccination

100 (96.8, 100)

74.8 (65.8, 82.4)

Post-vaccination

100 (96.8, 100)c

100 (96.8, 100)d

Tde

35

Pre-vaccination

100 (90, 100)

77.1 (59.9, 89.6)

Post-vaccination

100 (90, 100)

100 (90, 100)

Anti-diphtheria

BOOSTRIXb

115

Pre-vaccination

100 (96.8, 100)

60.9 (51.3, 69.8)

Post-vaccination

100 (96.8, 100)c

100 (96.8, 100)d

Tde

35

Pre-vaccination

100 (90, 100)

65.7 (47.8, 80.9)

Post-vaccination

100 (90,100)

97.1 (85.1, 99.9)

Response to Pertussis Antigens: The GMCs to each of the pertussis antigens 1 month following revaccination with BOOSTRIX in subjects who had received an initial dose of BOOSTRIX 10 years earlier were compared with the GMCs of infants following a 3-dose primary series of PEDIARIX [see Clinical Studies (14.1)]. Table 17 presents the results for the ATP cohort for immunogenicity in both studies. Anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in adults 1 month after revaccination with BOOSTRIX were non-inferior to those of infants following a primary vaccination series with PEDIARIX.

Table 17. Ratio of GMCs to Pertussis Antigens following BOOSTRIX in Adults Aged 20 to 29 Years Compared with 3 Doses of PEDIARIX in Infants (ATP Cohort for Immunogenicity)
GMC = Geometric mean antibody concentration; CI = Confidence Interval; PT = Pertussis toxin; FHA = Filamentous hemagglutinin; PRN = Pertactin.n = Number of subjects for GMC evaluation.a Subjects who were revaccinated with BOOSTRIX 10 years after initial vaccination with BOOSTRIX.b BOOSTRIX was non-inferior to PEDIARIX (lower limit of 95% CI for the GMC ratio of BOOSTRIX/PEDIARIX ≥0.67).

BOOSTRIXa

PEDIARIX

GMC Ratio: BOOSTRIX/PEDIARIX

Pertussis Antibodies

(n)

(n)

(95% CI)

Anti-PT

115

149

1.81 (1.48, 2.21)b

Anti-FHA

115

149

2.37 (1.98, 2.83)b

Anti-PRN

115

149

9.87 (7.80, 12.49)b

Adults (Aged 28 to 73 Years)

A multicenter, open-label, controlled study conducted in the United States evaluated the immunogenicity of BOOSTRIX in adults aged 28 to 73 years who received an initial dose of BOOSTRIX (n = 309) or the licensed comparator Tdap vaccine (Sanofi Pasteur) (n = 138) in the U.S. adult (aged 19 to 64 years) study. BOOSTRIX was administered to all subjects 9 years after initial vaccination. A control group of newly enrolled adult subjects received an initial dose of BOOSTRIX (n = 362). The immune responses to each of the antigens contained in BOOSTRIX were evaluated in sera obtained approximately 1 month after vaccine administration. Of the subjects enrolled in this study, the mean age was 52.1 years; 62.6% were female, and 86.6% were White.

Response to Tetanus and Diphtheria Toxoids: The antibody responses to the tetanus and diphtheria toxoids of BOOSTRIX are shown in Table 18. One month after vaccination, anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between groups.

Table 18. Antibody Responses to Tetanus and Diphtheria Toxoids following BOOSTRIX in Adults Aged 28 to 73 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.n = Number of subjects with available results.a Measured by ELISA.b Booster response: In subjects with pre-vaccination <0.1 IU/mL, post-vaccination concentration ≥0.4 IU/mL. In subjects with pre-vaccination concentration ≥0.1 IU/mL, an increase of at least 4 times the pre-vaccination concentration.c Subjects who were revaccinated with BOOSTRIX 9 years after initial vaccination with BOOSTRIX.d Seroprotection rates following a dose of BOOSTRIX in subjects who had received an initial dose of BOOSTRIX or the licensed comparator Tdap vaccine were non-inferior to an initial dose of BOOSTRIX (Control Group) (lower limit of 97.5% CI on the difference of BOOSTRIX minus Control Group ≥-10%).e Non-inferiority criteria not prospectively defined for this endpoint.f The booster response rates following a dose of BOOSTRIX in subjects who had received an initial dose of BOOSTRIX or the licensed comparator Tdap vaccine did not meet the pre-defined non-inferiority criteria (lower limit of the 97.5% CIs ≥-10% [BOOSTRIX minus Control Group] and [Tdap minus Control Group]).g Subjects who received a dose of BOOSTRIX 9 years after initial vaccination with Tdap vaccine.h Control Group = Newly enrolled subjects who received an initial dose of BOOSTRIX.

Antibodies

n

% ≥0.1 IU/mLa

(95% CI)

% ≥1.0 IU/mLa

(95% CI)

% Booster Responseb

(95% CI)

Anti-tetanus

BOOSTRIXc

268-271

Pre-vaccination

98.1 (95.7, 99.4)

78.7 (73.3, 83.5)

Post-vaccination

100 (98.6, 100)d

99.3 (97.4, 99.9)e

47.0 (40.9, 53.2)f

Tdapg

120-121

Pre-vaccination

100 (97.0, 100)

84.2 (76.4, 90.2)

Post-vaccination

100 (97.0, 100)d

100 (97.0, 100)e

36.7 (28.1, 45.9)f

Controlh

324-327

Pre-vaccination

93.8 (90.6, 96.2)

71.3 (66.0, 76.2)

Post-vaccination

99.7 (98.3, 100)

97.6 (95.2, 98.9)

48.5 (42.9, 54.0)

Anti-diphtheria

BOOSTRIXc

269-271

Pre-vaccination

91.1 (87.0, 94.2)

42.4 (36.4, 48.5)

Post-vaccination

99.3 (97.4, 99.9)d

91.9 (88.0, 94.8)e

62.8 (56.7, 68.6)f

Tdapg

118-121

Pre-vaccination

95.8 (90.4, 98.6)

45.8 (36.6, 55.2)

Post-vaccination

99.2 (95.5, 100)d

93.4 (87.4, 97.1)e

60.2 (50.7, 69.1)f

Controlh

324-326

Pre-vaccination

81.8 (77.1, 85.8)

28.4 (23.5, 33.6)

Post-vaccination

97.9 (95.6, 99.1)

86.5 (82.3, 90.0)

68.7 (63.4, 73.7)

Response to Pertussis Antigens: The GMCs to each of the pertussis antigens 1 month following a dose of BOOSTRIX in subjects who had received an initial dose of BOOSTRIX or the licensed comparator Tdap vaccine (Sanofi Pasteur) 9 years earlier were compared with the GMCs of infants following a 3-dose primary series of PEDIARIX [see Clinical Studies (14.1)]. Table 19 presents the results for the ATP cohort for immunogenicity in both studies. Anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in adults 1 month after a dose of BOOSTRIX were non-inferior to those of infants following a primary vaccination series with PEDIARIX.

Table 19. Ratio of GMCs to Pertussis Antigens following BOOSTRIX in Adults Aged 28 to 73 Years Compared with 3 Doses of PEDIARIX in Infants (ATP Cohort for Immunogenicity)
Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed manufactured by Sanofi Pasteur.GMC = Geometric mean antibody concentration; CI = Confidence Interval; PT = Pertussis toxin; FHA = Filamentous hemagglutinin; PRN = Pertactin.n = Number of subjects for GMC evaluation.a BOOSTRIX was non-inferior to PEDIARIX (lower limit of 97.5% CI for the GMC ratio of BOOSTRIX/PEDIARIX ≥0.67).

Pertussis Antibodies

Vaccinated with BOOSTRIX 9 Years after Initial Vaccination with:

PEDIARIX

(n)

GMC Ratio:

BOOSTRIX

(n)

Tdap

(n)

BOOSTRIX/

PEDIARIX

(97.5% CI)

Tdap/

PEDIARIX

(97.5% CI)

Anti-PT

271

121

149

1.33

(1.09, 1.61)a

1.46

(1.14, 1.87)a

Anti-FHA

271

121

149

2.02

(1.72, 2.37)a

2.07

(1.68, 2.57)a

Anti-PRN

271

121

149

8.64

(6.85, 10.89)a

10.90

(8.27, 14.38)a

Compared with the Control Group, non-inferiority of booster response rates to the pertussis antigens following a dose of BOOSTRIX in subjects who had received an initial dose of BOOSTRIX or another licensed Tdap vaccine (Sanofi Pasteur) was achieved for the PT antigen [BOOSTRIX minus Control Group] and the FHA antigen [Tdap minus Control Group], respectively (Table 20). Non-inferiority was not achieved for FHA and PRN booster response rates [BOOSTRIX minus Control Group] or for PT and PRN booster response rates [Tdap minus Control Group].

Table 20. Booster Responses to the Pertussis Antigens following BOOSTRIX in Adults Aged 28 to 73 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; PT = Pertussis toxin; FHA = Filamentous hemagglutinin; PRN = Pertactin.n = Number of subjects with available results.a Booster response: In initially seronegative subjects (pre-vaccination antibody concentration below the assay cut-off), post-vaccination antibody concentrations ≥4 times the assay cut-off. In initially seropositive subjects with pre-vaccination antibody concentrations <4 times the assay cut-off, an increase of at least 4 times the pre-vaccination antibody concentration. In initially seropositive subjects with pre-vaccination antibody concentrations ≥4 times the assay cut-off, an increase of at least 2 times the pre-vaccination antibody concentration. Assay cut-offs: anti-PT = 2.693 IU/mL; anti-FHA = 2.046 IU/mL; anti-PRN = 2.187 IU/mL.b Subjects who were revaccinated with BOOSTRIX 9 years after initial vaccination with BOOSTRIX.c Non-inferiority of the booster response rate for each pertussis antigen was demonstrated if the lower limit of the 97.5% CI [BOOSTRIX minus Control Group] or [Tdap minus Control Group] was above the pre-defined limit of -10%.d Subjects who received a dose of BOOSTRIX 9 years after initial vaccination with Tdap vaccine.e Control Group = Newly enrolled subjects who received an initial dose of BOOSTRIX.

Pertussis Antibodies

n

% Booster Responsea

(95% CI)

Difference in Booster Response Rates

BOOSTRIX minus

Control Group

(97.5 % CI)

Tdap minus Control Group (97.5% CI)

Anti-PT

BOOSTRIXb

271

86.7 (82.1, 90.5)

-2.85 (-9.09, 3.08)c

Tdapd

120

88.3 (81.2, 93.5)

-1.24 (-10.03, 5.57)

Controle

326

89.6 (85.7, 92.7)

Anti-FHA

BOOSTRIXb

271

85.6 (80.9, 89.6)

-7.05 (-13.16, -1.40)

Tdapd

120

96.7 (91.7, 99.1)

4.01 (-2.38, 8.66)c

Controle

327

92.7 (89.3, 95.2)

Anti-PRN

BOOSTRIXb

271

77.5 (72.0, 82.3)

-10.32 (-17.50, -3.38)

Tdapd

118

83.1 (75.0, 89.3)

-4.76 (-14.53, 3.18)

Controle

320

87.8 (83.7, 91.2)

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