Find a Drug
Advanced Search

Professional

Adacel

Clinical Pharmacology
font size

Clinical Pharmacology

† Seroprotection rates at ≥ 0.10 IU/mL and booster response rates to ADACEL vaccine were non-inferior to Td vaccine (upper limit of the 95% CI on the difference for Td vaccine minus ADACEL vaccine <10%).

† Seroprotection rates at ≥1.0 IU/mL were not designed as a primary endpoint, however ADACEL vaccine met non-inferiority criteria (upper limit of the 95% CI on the difference for Td vaccine minus ADACEL vaccine <10%) at this level.

Table 3: Ratio of Pertussis Antibody Geometric Mean Concentrations (GMCs)† Observed One Month After a Dose of ADACEL Vaccine in Adolescents and Adults Compared with Those Observed in Infants One Month Following Three Doses at 2, 4 and 6 Months of Age in an Efficacy Trial with DAPTACEL Vaccine

 

Adolescents

ADACEL/DAPTACEL

GMC Ratio*

(95% CIs)

Adults

ADACEL/DAPTACEL

GMC Ratio*

(95% CIs)

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)†

* The ratios of GMC were determined for adolescents compared to infants, as well as for adults compared to infants.

† GMC following ADACEL vaccine was non-inferior to GMC following DAPTACEL vaccine (lower limit of 95% CI on the ratio of GMC for ADACEL vaccine divided by DAPTACEL vaccine >0.67).

† Antibody GMCs, measured in arbitrary ELISA units were calculated separately for infants, adolescents and adults.

Table 4: Booster Responses to the Pertussis Antigens Observed One Month After a Dose of ADACEL Vaccine in Adolescents and Adults

Adolescents
N = 524
% (95% CI)
Adults
N = 739
% (95% CI)
Pre-defined Acceptable Rates* %†
Anti-PT

92

(89.3, 94.2)

84.4

(81.6, 87.0)

81.2
Anti-FHA

85.6

(82.3, 88.4)

82.7

(79.8, 85.3)

77.6
Anti-PRN

94.5

(92.2, 96.3)

93.8

(91.8, 95.4)

86.4
Anti-FIM

94.9

(92.6, 96.6)

85.9

(83.2, 88.4)

82.4
* 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.
Brand Name: Adacel
Generic Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Bookmark this page:
WebMD Symptom Checker - Start Here Diseases & Conditions: A comprehensive A-Z listing

Overscheduled Families Overscheduled Families
Do you run your kids from one activity to another, day after day? If so, you should take a minute to watch.See more WebMD Videos »

Parenting and Pregnancy

Get tips for baby and you.