Vaccine Information: Adacel TDaP (Page 3 of 6)

14.1 Immunological Evaluation in Adolescents and Adults, 11 through 64 Years of Age Following a First Vaccination with Adacel

Study Td506 was a comparative, multi-center, randomized, observer-blind, controlled trial which enrolled 4,480 participants; 2,053 adolescents (11-17 years of age) and 2,427 adults (18-64 years of age). Enrollment was stratified by age to ensure adequate representation across the entire age range. Participants had not received a tetanus or diphtheria toxoid containing vaccine within the previous 5 years. After enrollment participants were randomized to receive one dose of either Adacel or Td vaccine. A total of 4,461 randomized participants were vaccinated. The per-protocol immunogenicity subset included 1,270 Adacel recipients and 1,026 Td vaccine recipients. Sera were obtained before and approximately 35 days after vaccination. [Blinding procedures for safety assessments are described in ADVERSE REACTIONS (6). ]

Demographic characteristics were similar within age groups and between the vaccine groups. A total of 76% of the adolescents and 1.1% of the adults reported a history of receiving 5 previous doses of diphtheria-tetanus-pertussis containing vaccines. Anti-tetanus and anti-diphtheria seroprotection rates (≥0.1 IU/mL) and booster response rates were comparable between Adacel and Td vaccines. (See Table 4 and Table 5.) Adacel induced pertussis antibody levels that were non-inferior to those of Swedish infants who received three doses of DAPTACEL vaccine (Sweden I Efficacy Study). (See Table 6.) Acceptable booster responses to each of the pertussis antigens were also demonstrated, ie, the percentage of participants with a booster response exceeded the predefined lower limit. (See Table 7.)

Table 4: Pre-vaccination and Post-vaccination Antibody Responses and Booster Response Rates to Tetanus Toxoid Following A First Vaccination with Adacel Vaccine as Compared to Td Vaccine in Adolescents and Adults 11 through 64 Years of Age (Td506)
Anti-Tetanus toxoid (IU/mL)
Pre-vaccination 1 Month Post-vaccination
Age Group (years) Vaccine N * % ≥0.10(95% CI) % ≥1.0(95% CI) % ≥0.10(95% CI) % ≥1.0(95% CI) % Booster (95% CI)
*
N = number of participants in the per-protocol population with available data.
Booster response is defined as: A 4-fold rise in antibody concentration, if the pre-vaccination concentration was equal to or below the cut-off value and a 2-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. The cut-off value for tetanus was 2.7 IU/mL.
Seroprotection rates at ≥0.10 IU/mL and booster response rates to Adacel were non-inferior to Td vaccine (upper limit of the 95% CI on the difference for Td vaccine minus Adacel <10%).
§
Seroprotection rates at ≥1.0 IU/mL were not prospectively defined as a primary endpoint.
Tetanus and Diphtheria Toxoids Adsorbed manufactured by Sanofi Pasteur Inc., Swiftwater, PA.
11-17 Adacel 527 99.6(98.6, 100.0) 44.6(40.3, 49.0) 100.0(99.3, 100.0) 99.6§(98.6, 100.0) 91.7(89.0, 93.9)
Td 516 99.2(98.0, 99.8) 43.8(39.5, 48.2) 100.0(99.3, 100.0) 99.4(98.3, 99.9) 91.3(88.5, 93.6)
18-64 Adacel 742-743 97.3(95.9, 98.3) 72.9(69.6, 76.1) 100.0(99.5, 100.0) 97.8§(96.5, 98.8) 63.1(59.5, 66.6)
Td 509 95.9(93.8, 97.4) 70.3(66.2, 74.3) 99.8(98.9, 100.0) 98.2(96.7, 99.2) 66.8(62.5, 70.9)
Table 5: Pre-vaccination and Post-vaccination Antibody Responses and Booster Response Rates to Diphtheria Toxoid Following A First Vaccination with Adacel as Compared to Td Vaccine in Adolescents and Adults 11 through 64 Years of Age (Td506)
Anti-Diphtheria toxin (IU/mL)
Pre-vaccination 1 Month Post-vaccination
Age Group(years) Vaccine N * % ≥0.10(95% CI) % ≥1.0(95% CI) % ≥0.10(95% CI) % ≥1.0(95% CI) % Booster (95% CI)
*
N = number of participants in the per-protocol population with available data.
Booster response is defined as: A 4-fold rise in antibody concentration, if the pre-vaccination concentration was equal to or below the cut-off value and a 2-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. The cut-off value for diphtheria was 2.56 IU/mL.
Seroprotection rates at ≥0.10 IU/mL and booster response rates to Adacel were non-inferior to Td vaccine (upper limit of the 95% CI on the difference for Td vaccine minus Adacel <10%).
§
Seroprotection rates at ≥1.0 IU/mL were not prospectively defined as a primary endpoint.
Tetanus and Diphtheria Toxoids Adsorbed manufactured by Sanofi Pasteur Inc., Swiftwater, PA.
11-17 Adacel 527 72.5(68.5, 76.3) 15.7(12.7, 19.1) 99.8(98.9, 100.0) 98.7§(97.3, 99.5) 95.1(92.9, 96.8)
Td 515-516 70.7(66.5, 74.6) 17.3(14.1, 20.8) 99.8(98.9, 100.0) 98.4(97.0, 99.3) 95.0(92.7, 96.7)
18-64 Adacel 739-741 62.6(59.0, 66.1) 14.3(11.9, 17.0) 94.1(92.1, 95.7) 78.0§(74.8, 80.9) 87.4(84.8, 89.7)
Td 506-507 63.3(59.0, 67.5) 16.0(12.9, 19.5) 95.1(92.8, 96.8) 79.9(76.1, 83.3) 83.4(79.9, 86.5)
Table 6: Ratio of Pertussis Antibody Geometric Mean Concentrations (GMCs)* Observed One Month Following A First Vaccination with Adacel in Adolescents and Adults 11 through 64 Years of Age Compared with Those Observed in Infants One Month following Vaccination at 2,4 and 6 Months of Age in the Efficacy Trial with DAPTACEL (Sweden I Efficacy Study)
Adolescents 11-17 Years of Age Adults 18-64 Years of Age
Adacel /DAPTACEL GMC Ratio(95% CIs) Adacel §/DAPTACEL GMC Ratio(95% CIs)
*
Antibody GMCs, measured in arbitrary ELISA units were calculated separately for infants, adolescents and adults.
N = 524 to 526, number of adolescents in the per-protocol population with available data for Adacel.
N = 80, number of infants who received DAPTACEL with available data post dose 3 (Sweden Efficacy I).
§
N = 741, number of adults in the per-protocol population with available data for Adacel.
GMC following Adacel was non-inferior to GMC following DAPTACEL (lower limit of 95% CI on the ratio of GMC for Adacel divided by DAPTACEL >0.67).
Anti-PT 3.6(2.8, 4.5) 2.1(1.6, 2.7)
Anti-FHA 5.4(4.5, 6.5) 4.8(3.9, 5.9)
Anti-PRN 3.2(2.5, 4.1) 3.2(2.3, 4.4)
Anti-FIM 5.3(3.9, 7.1) 2.5(1.8, 3.5)
Table 7: Booster Response Rates to the Pertussis Antigens Observed One Month Following a First Vaccination with Adacel in Adolescents and Adults 11 through 64 Years of Age
Adolescents 11-17Years of Age Adults 18-64Years of Age PredefinedAcceptable Rates *%
N %(95% CI) N %(95% CI)
*
The acceptable response rate for each antigen was defined as the lower limit of the 95% CI for the rate being no more than 10% lower than the response rate observed in previous clinical trials.
A booster response for each antigen was defined as a 4-fold rise in antibody concentration if the pre-vaccination concentration was equal to or below the cut-off value and a 2-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. The cut-off values for pertussis antigens were established based on antibody data from both adolescents and adults in previous clinical trials. The cut-off values were 85 EU/mL for PT, 170 EU/mL for FHA, 115 EU/mL for PRN and 285 EU/mL for FIM.
N = number of participants in the per-protocol population with available data.
Anti-PT 524 92.0(89.3, 94.2) 739 84.4(81.6, 87.0) 81.2
Anti-FHA 526 85.6(82.3, 88.4) 739 82.7(79.8, 85.3) 77.6
Anti-PRN 525 94.5(92.2, 96.3) 739 93.8(91.8, 95.4) 86.4
Anti-FIM 526 94.9(92.6, 96.6) 739 85.9(83.2, 88.4) 82.4

Study Td519 assessed the comparative immunogenicity of a first vaccination with Adacel administered to adolescents (10 to <11 years of age and 11 to <12 years of age) [See ADVERSE REACTIONS (6.1).] In this study non-inferiority was demonstrated for booster responses to tetanus and diphtheria toxoids, GMCs to the pertussis antigens (PT, FHA, PRN and FIM) and booster responses to the pertussis antigens PT, FHA and PRN. For FIM, non-inferiority was not demonstrated as the lower bound of the 95% CI of the difference in booster response rates (-5.96%) did not meet the predefined criterion (>-5% when the booster response in the older age group was >95%).

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.