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Tdap Vaccine in Post-Partum Women

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ClinicalTrials.gov Identifier: NCT01711645
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Primary Purpose: Prevention
Conditions Diphtheria
Pertussis
Tetanus
Intervention Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
Enrollment 55
Recruitment Details Postpartum participants were recruited within 1-4 days of full-term delivery in the Nashville area between 26Oct2012 and 03Sep2013.
Pre-assignment Details  
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Period Title: Overall Study
Started 55
Completed 36
Not Completed 19
Reason Not Completed
Withdrawal by Subject             8
Lost to Follow-up             6
Physician Decision             5
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
0
   0.0%
Between 18 and 65 years
55
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
30.1  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
55
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
55
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.8%
White
52
  94.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
Hide Description Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).
Time Frame Prior to and 2 weeks following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 52
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
PT
4.8
(3.8 to 5.9)
FHA
8.6
(7.2 to 10.4)
PRN
21.6
(14.4 to 32.5)
FIM
22.4
(12.4 to 40.5)
2.Primary Outcome
Title Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6
Hide Description Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
Time Frame Prior to and 6 weeks following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 53
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
PT
3.5
(2.9 to 4.4)
FHA
6.7
(5.7 to 8.0)
PRN
19.1
(12.5 to 29.1)
FIM
18.6
(11.1 to 31.1)
3.Primary Outcome
Title Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6
Hide Description Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
Time Frame Prior to and 6 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
PT
1.9
(1.6 to 2.3)
FHA
3.4
(3.0 to 3.9)
PRN
8.1
(5.5 to 12.0)
FIM
10.1
(6.2 to 16.3)
4.Primary Outcome
Title Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12
Hide Description Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
Time Frame Prior to and 12 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
PT
1.6
(1.4 to 1.9)
FHA
2.5
(2.2 to 2.8)
PRN
5.1
(3.6 to 7.1)
FIM
6.9
(4.3 to 11.0)
5.Primary Outcome
Title Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18
Hide Description Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
Time Frame Prior to and 18 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 46
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
PT
1.6
(1.4 to 1.8)
FHA
2.4
(2.1 to 2.8)
PRN
4.6
(3.3 to 6.4)
FIM
6.8
(4.3 to 10.8)
6.Primary Outcome
Title Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24
Hide Description Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
Time Frame Prior to and 24 months following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Rise
PT
1.4
(1.2 to 1.6)
FHA
2.2
(1.9 to 2.5)
PRN
4.9
(3.3 to 7.4)
FIM
7.0
(4.0 to 12.2)
7.Primary Outcome
Title ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline
Hide Description Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (<10 EU/mL). The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame Baseline (prior to vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
6.6
(5.7 to 7.7)
FHA
15.9
(12.6 to 20.1)
PRN
20.3
(14.1 to 29.2)
FIM
38.1
(23.4 to 62.1)
8.Primary Outcome
Title ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2
Hide Description Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame 2 weeks post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 52
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
51.5
(39.2 to 67.7)
FHA
154.3
(132.3 to 179.9)
PRN
581.5
(430.4 to 785.6)
FIM
1156.3
(794.2 to 1683.5)
9.Primary Outcome
Title ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6
Hide Description Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame 6 weeks post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 53
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
37.5
(28.5 to 49.3)
FHA
126.1
(106.5 to 149.2)
PRN
496.8
(355.6 to 694.1)
FIM
905.1
(663.2 to 1235.2)
10.Primary Outcome
Title ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6
Hide Description Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame 6 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
19.2
(15.0 to 24.6)
FHA
62.4
(53.3 to 73.0)
PRN
212.3
(149.9 to 300.9)
FIM
492.8
(358.4 to 677.6)
11.Primary Outcome
Title ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12
Hide Description Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame 12 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
15.1
(11.6 to 19.6)
FHA
46.2
(39.0 to 54.8)
PRN
141.1
(103.4 to 192.6)
FIM
368.7
(264.2 to 514.5)
12.Primary Outcome
Title ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18
Hide Description Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame 18 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 46
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
15.1
(12.0 to 19.1)
FHA
44.6
(35.4 to 56.2)
PRN
121.1
(84.0 to 174.5)
FIM
330.7
(234.6 to 466.1)
13.Primary Outcome
Title ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24
Hide Description Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.
Time Frame 24 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
PT
10.8
(7.9 to 14.6)
FHA
39.0
(30.1 to 50.6)
PRN
114.1
(74.9 to 173.9)
FIM
298.0
(187.3 to 474.0)
14.Primary Outcome
Title Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2
Hide Description Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
Time Frame Prior to and 2 weeks after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with blood collected and results reported at both timepoints are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 52
Measure Type: Count of Participants
Unit of Measure: Participants
PT
31
  59.6%
FHA
45
  86.5%
PRN
43
  82.7%
FIM
34
  65.4%
15.Primary Outcome
Title Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6
Hide Description Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
Time Frame Prior to and 6 weeks after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with blood collected and results reported at both timepoints are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
PT
21
  39.6%
FHA
44
  83.0%
PRN
42
  79.2%
FIM
34
  64.2%
16.Primary Outcome
Title Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6
Hide Description Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
Time Frame Prior to and 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with blood collected and results reported at both timepoints are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
PT
5
  10.2%
FHA
18
  36.7%
PRN
34
  69.4%
FIM
29
  59.2%
17.Primary Outcome
Title Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12
Hide Description Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
Time Frame Prior to and 12 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with blood collected and results reported at both timepoints are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
PT
5
  10.4%
FHA
5
  10.4%
PRN
28
  58.3%
FIM
26
  54.2%
18.Primary Outcome
Title Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18
Hide Description Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
Time Frame Prior to and 18 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with blood collected and results reported at both timepoints are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
PT
3
   6.5%
FHA
7
  15.2%
PRN
25
  54.3%
FIM
26
  56.5%
19.Primary Outcome
Title Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24
Hide Description Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
Time Frame Prior to and 24 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with blood collected and results reported at both timepoints are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
PT
1
   2.9%
FHA
2
   5.7%
PRN
19
  54.3%
FIM
20
  57.1%
20.Primary Outcome
Title Kinetics of the ELISA IgG Antibody Rise in Serum
Hide Description The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.
Time Frame Prior to and following Tdap, through 24 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.
Hide Description Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5).
Time Frame Baseline (prior to vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
28.8
(2.5 to 336.9)
22.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to PT at Week 2
Hide Description Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Time Frame 2 weeks post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 34
Geometric Mean (Full Range)
Unit of Measure: EU/mL
5.0
(5.0 to 5.0)
23.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to PT at Week 6
Hide Description Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Time Frame 6 weeks post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 35
Geometric Mean (Full Range)
Unit of Measure: EU/mL
5.0
(5.0 to 5.0)
24.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to PT at Month 6
Hide Description Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Time Frame 6 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 22
Geometric Mean (Full Range)
Unit of Measure: EU/mL
5.0
(5.0 to 5.0)
25.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to FHA at Baseline.
Hide Description Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
Time Frame Baseline (prior to vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
28.3
(6.9 to 116.6)
26.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to FHA at Week 2.
Hide Description Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
Time Frame 2 weeks post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
5.4
(4.8 to 6.0)
27.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to FHA at Week 6.
Hide Description Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Time Frame 6 weeks post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 35
Geometric Mean (Full Range)
Unit of Measure: EU/mL
5.0
(5.0 to 5.0)
28.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to FHA at Month 6.
Hide Description Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
Time Frame 6 months post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants providing a breast milk sample at the timepoint are included in the analysis population.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
5.2
(4.8 to 5.8)
29.Secondary Outcome
Title ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.
Hide Description Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.
Time Frame Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.
Hide Description Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.
Time Frame Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
31.Secondary Outcome
Title Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day
Hide Description Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.
Time Frame Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
32.Secondary Outcome
Title Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.
Hide Description Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.
Time Frame Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description:
Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Since pertussis vaccine is offered as standard of care to healthy adults, including postpartum women, anticipated AEs related to pertussis vaccine administration, as per Package Insert, were not collected. AEs reported for this protocol were limited to 1. severe vaso-vagal reaction, including loss of consciousness or > grade 2 hypotension, associated with the blood draw; and 2. adverse events leading to infection or inability to breast feed following the use of the breast pump.
Adverse Event Reporting Description Anticipated adverse events related to administration of the pertussis vaccine as per Package Insert include injection site reactions (pain, swelling and erythema) and systemic reactions (headache body ache and muscle weakness). Events meeting VAERS reporting requirements were to be reported to VAERS and not collected for this protocol.
 
Arm/Group Title Adacel® Tdap Vaccine
Hide Arm/Group Description Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
All-Cause Mortality
Adacel® Tdap Vaccine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adacel® Tdap Vaccine
Affected / at Risk (%)
Total   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adacel® Tdap Vaccine
Affected / at Risk (%)
Total   0/55 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathryn M. Edwards, MD
Organization: Vanderbilt Medical Center
Phone: 615-322-3078
EMail: Kathryn.edwards@vanderbilt.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01711645     History of Changes
Other Study ID Numbers: 11-0035
HHSN272201300023I
First Submitted: October 18, 2012
First Posted: October 22, 2012
Results First Submitted: November 23, 2016
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017