Trial Outcomes & Findings for Tdap Vaccine in Post-Partum Women (NCT NCT01711645)

NCT ID: NCT01711645

Last Updated: 2017-05-05

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: Prior to and 2 weeks following vaccination
• Results posted on: 2017-05-05

Participant Flow

Postpartum participants were recruited within 1-4 days of full-term delivery in the Nashville area between 26Oct2012 and 03Sep2013.

Participant milestones

Measure	Adacel® Tdap Vaccine 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 Study STARTED	55
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Adacel® Tdap Vaccine 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 Study Withdrawal by Subject	8
Overall Study Lost to Follow-up	6
Overall Study Physician Decision	5

Baseline Characteristics

Tdap Vaccine in Post-Partum Women

Baseline characteristics by cohort

Measure	Adacel® Tdap Vaccine n=55 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.1 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to and 2 weeks following vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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).

Outcome measures

Measure	Adacel® Tdap Vaccine n=52 Participants 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
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2 PT	4.8 Fold Rise Interval 3.8 to 5.9
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2 FHA	8.6 Fold Rise Interval 7.2 to 10.4
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2 PRN	21.6 Fold Rise Interval 14.4 to 32.5
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2 FIM	22.4 Fold Rise Interval 12.4 to 40.5

PRIMARY outcome

Timeframe: Prior to and 6 weeks following vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=53 Participants 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
Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6 PT	3.5 Fold Rise Interval 2.9 to 4.4
Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6 FHA	6.7 Fold Rise Interval 5.7 to 8.0
Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6 PRN	19.1 Fold Rise Interval 12.5 to 29.1
Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6 FIM	18.6 Fold Rise Interval 11.1 to 31.1

PRIMARY outcome

Timeframe: Prior to and 6 months following vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=49 Participants 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
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6 PT	1.9 Fold Rise Interval 1.6 to 2.3
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6 FHA	3.4 Fold Rise Interval 3.0 to 3.9
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6 PRN	8.1 Fold Rise Interval 5.5 to 12.0
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6 FIM	10.1 Fold Rise Interval 6.2 to 16.3

PRIMARY outcome

Timeframe: Prior to and 12 months following vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=48 Participants 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
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12 PT	1.6 Fold Rise Interval 1.4 to 1.9
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12 FHA	2.5 Fold Rise Interval 2.2 to 2.8
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12 PRN	5.1 Fold Rise Interval 3.6 to 7.1
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12 FIM	6.9 Fold Rise Interval 4.3 to 11.0

PRIMARY outcome

Timeframe: Prior to and 18 months following vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=46 Participants 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
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18 PT	1.6 Fold Rise Interval 1.4 to 1.8
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18 FHA	2.4 Fold Rise Interval 2.1 to 2.8
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18 PRN	4.6 Fold Rise Interval 3.3 to 6.4
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18 FIM	6.8 Fold Rise Interval 4.3 to 10.8

PRIMARY outcome

Timeframe: Prior to and 24 months following vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=35 Participants 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
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24 PT	1.4 Fold Rise Interval 1.2 to 1.6
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24 FHA	2.2 Fold Rise Interval 1.9 to 2.5
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24 PRN	4.9 Fold Rise Interval 3.3 to 7.4
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24 FIM	7.0 Fold Rise Interval 4.0 to 12.2

PRIMARY outcome

Timeframe: Baseline (prior to vaccination)

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=55 Participants 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
ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline PT	6.6 EU/mL Interval 5.7 to 7.7
ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline FHA	15.9 EU/mL Interval 12.6 to 20.1
ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline PRN	20.3 EU/mL Interval 14.1 to 29.2
ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline FIM	38.1 EU/mL Interval 23.4 to 62.1

PRIMARY outcome

Timeframe: 2 weeks post vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=52 Participants 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
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2 PT	51.5 EU/mL Interval 39.2 to 67.7
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2 FHA	154.3 EU/mL Interval 132.3 to 179.9
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2 PRN	581.5 EU/mL Interval 430.4 to 785.6
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2 FIM	1156.3 EU/mL Interval 794.2 to 1683.5

PRIMARY outcome

Timeframe: 6 weeks post vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=53 Participants 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
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6 PT	37.5 EU/mL Interval 28.5 to 49.3
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6 FHA	126.1 EU/mL Interval 106.5 to 149.2
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6 PRN	496.8 EU/mL Interval 355.6 to 694.1
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6 FIM	905.1 EU/mL Interval 663.2 to 1235.2

PRIMARY outcome

Timeframe: 6 months post vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=49 Participants 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
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6 PT	19.2 EU/mL Interval 15.0 to 24.6
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6 FHA	62.4 EU/mL Interval 53.3 to 73.0
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6 PRN	212.3 EU/mL Interval 149.9 to 300.9
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6 FIM	492.8 EU/mL Interval 358.4 to 677.6

PRIMARY outcome

Timeframe: 12 months post vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=48 Participants 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
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12 PT	15.1 EU/mL Interval 11.6 to 19.6
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12 FHA	46.2 EU/mL Interval 39.0 to 54.8
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12 PRN	141.1 EU/mL Interval 103.4 to 192.6
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12 FIM	368.7 EU/mL Interval 264.2 to 514.5

PRIMARY outcome

Timeframe: 18 months post vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=46 Participants 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
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18 PT	15.1 EU/mL Interval 12.0 to 19.1
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18 FHA	44.6 EU/mL Interval 35.4 to 56.2
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18 PRN	121.1 EU/mL Interval 84.0 to 174.5
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18 FIM	330.7 EU/mL Interval 234.6 to 466.1

PRIMARY outcome

Timeframe: 24 months post vaccination

Population: All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=35 Participants 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
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24 PT	10.8 EU/mL Interval 7.9 to 14.6
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24 FHA	39.0 EU/mL Interval 30.1 to 50.6
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24 PRN	114.1 EU/mL Interval 74.9 to 173.9
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24 FIM	298.0 EU/mL Interval 187.3 to 474.0

PRIMARY outcome

Timeframe: Prior to and 2 weeks after vaccination

Population: All participants with blood collected and results reported at both timepoints are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=52 Participants 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
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2 PT	31 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2 FHA	45 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2 PRN	43 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2 FIM	34 Participants

PRIMARY outcome

Timeframe: Prior to and 6 weeks after vaccination

Population: All participants with blood collected and results reported at both timepoints are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=53 Participants 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
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6 PT	21 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6 FHA	44 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6 PRN	42 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6 FIM	34 Participants

PRIMARY outcome

Timeframe: Prior to and 6 months after vaccination

Population: All participants with blood collected and results reported at both timepoints are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=49 Participants 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
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6 PT	5 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6 FHA	18 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6 PRN	34 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6 FIM	29 Participants

PRIMARY outcome

Timeframe: Prior to and 12 months after vaccination

Population: All participants with blood collected and results reported at both timepoints are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=48 Participants 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
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12 PT	5 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12 FHA	5 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12 PRN	28 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12 FIM	26 Participants

PRIMARY outcome

Timeframe: Prior to and 18 months after vaccination

Population: All participants with blood collected and results reported at both timepoints are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=46 Participants 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
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18 PT	3 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18 FHA	7 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18 PRN	25 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18 FIM	26 Participants

PRIMARY outcome

Timeframe: Prior to and 24 months after vaccination

Population: All participants with blood collected and results reported at both timepoints are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=35 Participants 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
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24 PT	1 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24 FHA	2 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24 PRN	19 Participants
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24 FIM	20 Participants

PRIMARY outcome

Timeframe: Prior to and following Tdap, through 24 months post-vaccination

Population: No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (prior to vaccination)

Population: All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.

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).

Outcome measures

Measure	Adacel® Tdap Vaccine n=4 Participants 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
ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.	28.8 EU/mL Interval 2.5 to 336.9

SECONDARY outcome

Timeframe: 2 weeks post vaccination

Population: All participants providing a breast milk sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=34 Participants 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
ELISA GMC of Breast Milk IgA to PT at Week 2	5.0 EU/mL Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: 6 weeks post vaccination

Population: All participants providing a breast milk sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=35 Participants 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
ELISA GMC of Breast Milk IgA to PT at Week 6	5.0 EU/mL Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: 6 months post vaccination

Population: All participants providing a breast milk sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=22 Participants 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
ELISA GMC of Breast Milk IgA to PT at Month 6	5.0 EU/mL Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: Baseline (prior to vaccination)

Population: All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=4 Participants 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
ELISA GMC of Breast Milk IgA to FHA at Baseline.	28.3 EU/mL Interval 6.9 to 116.6

SECONDARY outcome

Timeframe: 2 weeks post vaccination

Population: All participants providing a breast milk sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=34 Participants 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
ELISA GMC of Breast Milk IgA to FHA at Week 2.	5.4 EU/mL Interval 4.8 to 6.0

SECONDARY outcome

Timeframe: 6 weeks post vaccination

Population: All participants providing a breast milk sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=35 Participants 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
ELISA GMC of Breast Milk IgA to FHA at Week 6.	5.0 EU/mL Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: 6 months post vaccination

Population: All participants providing a breast milk sample at the timepoint are included in the analysis population.

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.

Outcome measures

Measure	Adacel® Tdap Vaccine n=22 Participants 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
ELISA GMC of Breast Milk IgA to FHA at Month 6.	5.2 EU/mL Interval 4.8 to 5.8

SECONDARY outcome

Timeframe: Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination

Population: The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Adacel® Tdap Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathryn M. Edwards, MD

Vanderbilt Medical Center

Phone: 615-322-3078

Email: Kathryn.edwards@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60