Trial Outcomes & Findings for Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women (NCT NCT02783170)
NCT ID: NCT02783170
Last Updated: 2025-07-28
Results Overview
Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
8 days post vaccine administration
Results posted on
2025-07-28
Participant Flow
Participant milestones
| Measure |
Simultaneous Vaccination Arm
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
38
|
|
Overall Study
Safety Population
|
42
|
38
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Simultaneous Vaccination Arm
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Overall Study
Randomized but not Vaccinated
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
Baseline characteristics by cohort
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 21 days later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Maternal Age
|
27 Years
n=99 Participants
|
25.5 Years
n=107 Participants
|
26 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Recent Tdap Vaccine within 2 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Recent Flu Vaccine within 2 years
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Gestational Age in Weeks at Visit 1
|
29.1 Weeks
n=99 Participants
|
28 Weeks
n=107 Participants
|
28.7 Weeks
n=206 Participants
|
|
Gestational Age in Weeks at Visit 4
|
32.6 Weeks
n=99 Participants
|
31.9 Weeks
n=107 Participants
|
32.3 Weeks
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 days post vaccine administrationPopulation: Safety Population - subjects that were randomized and received the study intervention
Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Tenderness : Moderate
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Tenderness : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Tenderness : None
|
32.5 percentage of participants
Interval 18.6 to 49.1
|
54.1 percentage of participants
Interval 36.9 to 70.5
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Tenderness : Mild
|
55.0 percentage of participants
Interval 38.5 to 70.7
|
37.8 percentage of participants
Interval 22.5 to 55.2
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Pain : None
|
47.5 percentage of participants
Interval 31.5 to 63.9
|
48.6 percentage of participants
Interval 31.9 to 65.6
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Pain : Mild
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
45.9 percentage of participants
Interval 29.5 to 63.1
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Pain : Moderate
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Pain : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Pain : None
|
55.0 percentage of participants
Interval 38.5 to 70.7
|
70.6 percentage of participants
Interval 52.5 to 84.9
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Pain : Mild
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Pain : Moderate
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Pain : Severe
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Tenderness : None
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
50.0 percentage of participants
Interval 32.4 to 67.6
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Tenderness : Mild
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
17.6 percentage of participants
Interval 6.8 to 34.5
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Tenderness : Moderate
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
29.4 percentage of participants
Interval 15.1 to 47.5
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Tenderness : Severe
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Redness : None
|
92.5 percentage of participants
Interval 79.6 to 98.4
|
83.8 percentage of participants
Interval 68.0 to 93.8
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Redness : Mild
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Redness : Moderate
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
2.7 percentage of participants
Interval 0.7 to 14.2
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Redness : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Swelling : None
|
92.5 percentage of participants
Interval 79.6 to 98.4
|
89.2 percentage of participants
Interval 74.6 to 97.0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Swelling : Mild
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Swelling : Moderate
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
2.7 percentage of participants
Interval 0.7 to 14.2
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Flu Swelling : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval 0.0 to 9.5
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Redness : None
|
85.0 percentage of participants
Interval 70.2 to 94.3
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Redness : Mild
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Redness : Moderate
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Redness : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Swelling : None
|
82.5 percentage of participants
Interval 67.2 to 92.7
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Swelling : Mild
|
17.5 percentage of participants
Interval 7.3 to 32.8
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Swelling : Moderate
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
2.9 percentage of participants
Interval 0.1 to 14.2
|
|
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration
Tdap Swelling : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
PRIMARY outcome
Timeframe: 8 days post vaccine administrationPopulation: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=40 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=37 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fever : None
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
94.6 percentage of participants
Interval 81.8 to 99.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fatigue : None
|
65.0 percentage of participants
Interval 48.3 to 79.4
|
78.4 percentage of participants
Interval 61.8 to 90.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fever : Mild
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fever : Moderate
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fever : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Abdominal Pain : None
|
90.0 percentage of participants
Interval 76.3 to 97.2
|
97.3 percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Abdominal Pain : Mild
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Abdominal Pain : Moderate
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Abdominal Pain : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Aches : None
|
65.0 percentage of participants
Interval 48.3 to 79.4
|
78.4 percentage of participants
Interval 61.8 to 90.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Aches : Mild
|
20.0 percentage of participants
Interval 9.1 to 35.6
|
18.9 percentage of participants
Interval 8.0 to 35.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Aches : Moderate
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Aches : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Rash : None
|
90.0 percentage of participants
Interval 76.3 to 97.2
|
97.3 percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Rash : Mild
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Rash : Moderate
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Body Rash : Severe
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Chills Shivering : None
|
90.0 percentage of participants
Interval 76.3 to 97.2
|
91.9 percentage of participants
Interval 78.1 to 98.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Chills Shivering : Mild
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Chills Shivering : Moderate
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Chills Shivering : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Diarrhea : None
|
87.5 percentage of participants
Interval 73.2 to 95.8
|
89.2 percentage of participants
Interval 74.6 to 97.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Diarrhea : Mild
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
10.8 percentage of participants
Interval 3.0 to 25.4
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Diarrhea : Moderate
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Diarrhea : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fatigue : Mild
|
20.0 percentage of participants
Interval 9.1 to 35.6
|
16.2 percentage of participants
Interval 6.2 to 32.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fatigue : Moderate
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Fatigue : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Headache : None
|
70.0 percentage of participants
Interval 53.5 to 83.4
|
75.7 percentage of participants
Interval 58.8 to 88.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Headache : Mild
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
18.9 percentage of participants
Interval 8.0 to 35.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Headache : Moderate
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Headache : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Joint Pain : None
|
82.5 percentage of participants
Interval 67.2 to 92.7
|
91.9 percentage of participants
Interval 78.1 to 98.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Joint Pain : Mild
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Joint Pain : Moderate
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Joint Pain : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Nausea : None
|
87.5 percentage of participants
Interval 73.2 to 95.8
|
89.2 percentage of participants
Interval 74.6 to 97.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Nausea : Mild
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
10.8 percentage of participants
Interval 3.0 to 25.4
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Nausea : Moderate
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Nausea : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Vomiting : None
|
85.0 percentage of participants
Interval 70.2 to 94.3
|
97.3 percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Vomiting : Mild
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Vomiting : Moderate
|
10 percentage of participants
Interval 2.8 to 23.7
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1
Vomiting : Severe
|
0 percentage of participants
Interval to 8.8
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 9.5
Cannot estimate lower bound as percentage is 0
|
PRIMARY outcome
Timeframe: 8 days post vaccine administrationPopulation: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=38 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=34 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Rash : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fever : None
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fever : Mild
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Abdominal Pain : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Aches : None
|
92.1 percentage of participants
Interval 78.6 to 98.3
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Aches : Mild
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Aches : Moderate
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Aches : Severe
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Rash : None
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Rash : Mild
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Body Rash : Moderate
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Chills Shivering : None
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Chills Shivering : Mild
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Chills Shivering : Moderate
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Chills Shivering : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Diarrhea : None
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Diarrhea : Mild
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Diarrhea : Moderate
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Diarrhea : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fatigue : None
|
84.2 percentage of participants
Interval 68.7 to 94.0
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fatigue : Mild
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fatigue : Moderate
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fatigue : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Headache : None
|
92.1 percentage of participants
Interval 78.6 to 98.3
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Headache : Mild
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Headache : Moderate
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Headache : Severe
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Joint Pain : None
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
94.1 percentage of participants
Interval 80.3 to 99.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Joint Pain : Mild
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Joint Pain : Moderate
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Joint Pain : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Nausea : None
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Nausea : Mild
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Nausea : Moderate
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Nausea : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Vomiting : None
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
91.2 percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Vomiting : Mild
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Vomiting : Moderate
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Vomiting : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fever : Moderate
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Fever : Severe
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Abdominal Pain : None
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Abdominal Pain : Mild
|
0 percentage of participants
Interval to 9.3
Cannot estimate lower bound as percentage is 0
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
|
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4
Abdominal Pain : Moderate
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval to 10.3
Cannot estimate lower bound as percentage is 0
|
PRIMARY outcome
Timeframe: Pre-vaccination and approximately 21 days post vaccination and at DeliveryPopulation: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
Measurement of serum antibody levels to pertussis antigens, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Pre-Vaccination - FHA
|
27.5 Concentration (IU/mL)
Interval 18.5 to 41.0
|
37.0 Concentration (IU/mL)
Interval 23.8 to 57.6
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Pre-Vaccination - FIM
|
87.3 Concentration (IU/mL)
Interval 46.9 to 162.4
|
20.8 Concentration (IU/mL)
Interval 10.5 to 41.1
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Pre-Vaccination - PRN
|
44.8 Concentration (IU/mL)
Interval 27.3 to 73.7
|
47.1 Concentration (IU/mL)
Interval 26.4 to 83.9
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Pre-Vaccination - PT
|
7.8 Concentration (IU/mL)
Interval 5.1 to 11.9
|
5.9 Concentration (IU/mL)
Interval 3.5 to 10.1
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Post-Vaccination - FHA
|
171.3 Concentration (IU/mL)
Interval 135.0 to 217.7
|
262.1 Concentration (IU/mL)
Interval 201.5 to 341.0
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Post-Vaccination - FIM
|
99.9 Concentration (IU/mL)
Interval 55.9 to 178.7
|
19.7 Concentration (IU/mL)
Interval 10.2 to 38.1
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Post-Vaccination - PRN
|
242.1 Concentration (IU/mL)
Interval 178.1 to 329.2
|
360.4 Concentration (IU/mL)
Interval 240.8 to 539.4
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Post-Vaccination - PT
|
37.6 Concentration (IU/mL)
Interval 26.8 to 52.9
|
38.6 Concentration (IU/mL)
Interval 28.4 to 52.3
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Maternal - FHA
|
118.3 Concentration (IU/mL)
Interval 89.9 to 155.6
|
199.8 Concentration (IU/mL)
Interval 146.7 to 272.1
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Maternal - FIM
|
81.2 Concentration (IU/mL)
Interval 44.0 to 149.9
|
18.9 Concentration (IU/mL)
Interval 10.3 to 34.9
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Maternal - PRN
|
174.1 Concentration (IU/mL)
Interval 122.0 to 248.5
|
297.1 Concentration (IU/mL)
Interval 194.7 to 453.4
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Maternal - PT
|
26.8 Concentration (IU/mL)
Interval 19.3 to 37.4
|
27.9 Concentration (IU/mL)
Interval 19.4 to 40.1
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Cord Blood - FHA
|
182 Concentration (IU/mL)
Interval 137.0 to 241.8
|
265.6 Concentration (IU/mL)
Interval 195.8 to 360.3
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Cord Blood - FIM
|
122.2 Concentration (IU/mL)
Interval 67.5 to 221.5
|
32.2 Concentration (IU/mL)
Interval 17.5 to 59.4
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Cord Blood - PRN
|
245.4 Concentration (IU/mL)
Interval 171.8 to 350.3
|
352.1 Concentration (IU/mL)
Interval 230.7 to 537.5
|
|
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers
Cord Blood - PT
|
46 Concentration (IU/mL)
Interval 32.4 to 65.2
|
43.4 Concentration (IU/mL)
Interval 29.8 to 62.3
|
PRIMARY outcome
Timeframe: Pre vaccination and approximately 21 days post vaccination and at DeliveryPopulation: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
Measurement of serum antibody levels to diphtheria toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=41 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=37 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Pre-Vaccination
|
62.5 percentage of participants
Interval 45.8 to 77.3
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
|
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Post-Vaccination
|
92.7 percentage of participants
Interval 80.1 to 98.5
|
100 percentage of participants
Interval 90.5 to
Cannot be estimated - value is already 100%
|
|
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Maternal Blood
|
92.1 percentage of participants
Interval 78.6 to 98.3
|
100.0 percentage of participants
Interval 90.5 to
Cannot be estimated - value is already 100%
|
|
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Cord Blood
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
100.0 percentage of participants
Interval 89.1 to
Cannot be estimated - value is already 100%
|
PRIMARY outcome
Timeframe: 21 days post vaccinationPopulation: Safety Population - all subjects receiving the study intervention. Participants analyzed include those that provided data.
Measurement of serum antibody levels to tetanus toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=41 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Pre-Vaccination
|
82.5 percentage of participants
Interval 67.2 to 92.7
|
84.2 percentage of participants
Interval 68.7 to 94.0
|
|
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Post-Vaccination
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
100 percentage of participants
Interval 90.5 to
Cannot be estimated - value is already 100%
|
|
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Maternal Blood
|
100.0 percentage of participants
Interval 90.7 to
Cannot be estimated - value is already 100%
|
97.3 percentage of participants
Interval 85.8 to 99.9
|
|
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)
Cord Blood
|
100.0 percentage of participants
Interval 90.7 to
Cannot be estimated - value is already 100%
|
100.0 percentage of participants
Interval 89.1 to
Cannot be estimated - value is already 100%
|
PRIMARY outcome
Timeframe: Pre and 21 days post vaccination and at DeliveryPopulation: Safety Population - subjects receiving the study intervention. Participants analyzed include those that provided data.
Measurement of serum antibody levels to influenza antigens in maternal blood and infant cord blood obtained at delivery
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=41 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H1N1: Maternal Seroprotection
|
89.5 percentage of participants
Interval 75.2 to 97.1
|
94.6 percentage of participants
Interval 81.8 to 99.3
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H1N1: Cord Blood Seroprotection
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
93.8 percentage of participants
Interval 79.2 to 99.2
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H3N2: Maternal Seroprotection
|
92.1 percentage of participants
Interval 78.6 to 98.3
|
94.6 percentage of participants
Interval 81.8 to 99.3
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H3N2: Cord Blood Seroprotection
|
100.0 percentage of participants
Interval 90.7 to
Cannot be estimated - value is already 100%
|
100.0 percentage of participants
Interval 89.1 to
Cannot be estimated - value is already 100%
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Brisbane: Maternal Seroprotection
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
51.4 percentage of participants
Interval 34.4 to 68.1
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Brisbane: Cord Blood Seroprotection
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
78.1 percentage of participants
Interval 60.0 to 90.7
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Phuket: Maternal Seroprotection
|
73.7 percentage of participants
Interval 56.9 to 86.6
|
67.6 percentage of participants
Interval 50.2 to 82.0
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Phuket: Cord Blood Seroprotection
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
87.5 percentage of participants
Interval 71.0 to 96.5
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H1N1: Pre-Vaccination Seroprotection
|
58.5 percentage of participants
Interval 42.1 to 73.7
|
71.1 percentage of participants
Interval 54.1 to 84.6
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H1N1: Post-Vaccination Seroprotection
|
90.2 percentage of participants
Interval 76.9 to 97.3
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H1N1: Seroconversion
|
39.0 percentage of participants
Interval 24.2 to 55.5
|
50.0 percentage of participants
Interval 33.4 to 66.6
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H3N2: Pre-Vaccination Seroprotection
|
53.7 percentage of participants
Interval 37.4 to 69.3
|
60.5 percentage of participants
Interval 43.4 to 76.0
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H3N2: Post-Vaccination Seroprotection
|
95.1 percentage of participants
Interval 83.5 to 99.4
|
92.1 percentage of participants
Interval 78.6 to 98.3
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
A/H3N2: Seroconversion
|
63.4 percentage of participants
Interval 46.9 to 77.9
|
65.8 percentage of participants
Interval 48.6 to 80.4
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Brisbane: Pre-Vaccination Seroprotection
|
14.6 percentage of participants
Interval 5.6 to 29.2
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Brisbane: Post-Vaccination Seroprotection
|
63.4 percentage of participants
Interval 46.9 to 77.9
|
63.2 percentage of participants
Interval 46.0 to 78.2
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Brisbane: Seroconversion
|
53.7 percentage of participants
Interval 37.4 to 69.3
|
50.0 percentage of participants
Interval 33.4 to 66.6
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Phuket: Pre-Vaccination Seroprotection
|
29.3 percentage of participants
Interval 16.1 to 45.5
|
47.4 percentage of participants
Interval 31.0 to 64.2
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Phuket: Post-Vaccination Seroprotection
|
78.0 percentage of participants
Interval 62.4 to 89.4
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
|
Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )
B/Phuket: Seroconversion
|
58.5 percentage of participants
Interval 42.1 to 73.7
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: All subjects recruited and enrolled in the study
Percentage of subjects recruited during 4 month enrollment period
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=81 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Subjects Recruited Enrollment Period
|
100.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Percentage of participants that completed all in-person and delivery visits
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits)
|
98.6 percentage of participants
|
97.7 percentage of participants
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Percentage of reactogenicity data days reported (days reported / total possible days)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility Reported as Percentage of Reactogenicity Data Collected
|
92.6 percentage of days
|
93.1 percentage of days
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Percentage of samples collected (sample timepoints collected / total possible sample timepoints)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility Reported as Percentage of Adequate Biospecimens Collected
|
94.0 percentage of samples
|
95.4 percentage of samples
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Timeliness is defined as collected within the visit window
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility Reported as Percentage of Timely Collected Biospecimens
|
94.0 percentage of samples
|
95.4 percentage of samples
|
SECONDARY outcome
Timeframe: Up to the 6-week postpartum visitPopulation: Safety Population - subjects randomized and received study intervention
The number of participants with adverse maternal outcomes at delivery. Missing data is data not collected or unavailable.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Number of Participants With Adverse Maternal Outcomes
Pre-term Birth (<37 weeks) · Yes
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Pre-term Birth (<37 weeks) · No
|
38 Participants
|
37 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Pre-term Birth (<37 weeks) · Missing
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Gestational Diabetes · Yes
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Gestational Diabetes · No
|
35 Participants
|
35 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Gestational Diabetes · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Gestational Hypertension · Yes
|
5 Participants
|
7 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Gestational Hypertension · No
|
36 Participants
|
31 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Gestational Hypertension · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Preeclampsia · Yes
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Preeclampsia · No
|
38 Participants
|
37 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Preeclampsia · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Severe Preeclampsia/HELLP · Yes
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Severe Preeclampsia/HELLP · No
|
40 Participants
|
38 Participants
|
|
Number of Participants With Adverse Maternal Outcomes
Severe Preeclampsia/HELLP · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: approximately 2 monthsPopulation: Safety Population - subjects randomized and received study intervention
Number of participants with adverse infant outcomes. Missing data is data not collected or unavailable.
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Small Gestational Age (SGA): Olsen et al. · Yes
|
2 Participants
|
4 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Small Gestational Age (SGA): Olsen et al. · No
|
40 Participants
|
34 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Small Gestational Age (SGA): Olsen et al. · Missing
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Neonatal Death · Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Neonatal Death · No
|
41 Participants
|
38 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Neonatal Death · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Hypoglycemia · Yes
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Hypoglycemia · No
|
41 Participants
|
37 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Hypoglycemia · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Respiratory · Yes
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Respiratory · No
|
41 Participants
|
37 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Respiratory · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Jaundice Requiring Phototherapy · Yes
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Jaundice Requiring Phototherapy · No
|
40 Participants
|
37 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Jaundice Requiring Phototherapy · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Transient Tachypnea · Yes
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Transient Tachypnea · No
|
40 Participants
|
38 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Transient Tachypnea · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Hematological · Yes
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Hematological · No
|
41 Participants
|
36 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Hematological · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Sepsis/Rule out Infection · Yes
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Sepsis/Rule out Infection · No
|
40 Participants
|
37 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Sepsis/Rule out Infection · Missing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Low Birth Weight (< 2500 g) · Yes
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Low Birth Weight (< 2500 g) · No
|
38 Participants
|
35 Participants
|
|
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review
Low Birth Weight (< 2500 g) · Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at the time of deliveryPopulation: Safety Population - subjects randomized and receiving study intervention
Percentage of participants with clinical chorioamnionitis
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Participants With Clinical Chorioamnionitis
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: after delivery, approximately up to 2 weeksPopulation: Safety Population - subjects randomized and received study intervention
Percentage of participants with histologic chorioamnionitis on surgical pathology examination of placental tissue
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue
|
19.0 percentage of participants
|
15.8 percentage of participants
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Percentage of blood samples received in testable condition (sufficient volume and quality)
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility as Measured by Percentage of Blood Samples in Testable Condition
|
100.0 percentage of samples
|
100.0 percentage of samples
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Percentage of blood samples received with sufficient volume for testing
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing
|
100.0 percentage of samples
|
100.0 percentage of samples
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: Safety Population - subjects randomized and received study intervention
Percentage of testable (sufficient volume and quality) blood samples completed
Outcome measures
| Measure |
Simultaneous Vaccination Arm
n=42 Participants
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 Participants
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Feasibility as Measured by Percentage of Testable Blood Samples Completed
|
100.0 percentage of samples
|
100.0 percentage of samples
|
Adverse Events
Simultaneous Vaccination Arm
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sequential Vaccination Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simultaneous Vaccination Arm
n=42 participants at risk
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 participants at risk
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine Rupture
|
2.4%
1/42 • Number of events 1 • Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 5% were collected and reported.
|
0.00%
0/38 • Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 5% were collected and reported.
|
Other adverse events
| Measure |
Simultaneous Vaccination Arm
n=42 participants at risk
In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
Sequential Vaccination Arm
n=38 participants at risk
In this study arm, subjects will receive the IIV vaccine during study visit 1. Approximately 3 weeks later, they will receive the Tdap vaccine during study visit 4.
Tetanus, Diphtheria, and Pertussis Vaccine
2016-2017 Quadrivalent Inactivated Influenza Vaccine
2017-2018 Quadrivalent Inactivated Influenza Vaccine
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/42 • Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 5% were collected and reported.
|
5.3%
2/38 • Number of events 2 • Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 5% were collected and reported.
|
|
General disorders
Headaches
|
4.8%
2/42 • Number of events 2 • Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 5% were collected and reported.
|
0.00%
0/38 • Adverse events and SAEs are captured up to 8 days post vaccination. Subjects are followed for SAEs up to the 6-week postpartum visit. Significant infant complications or SAEs identified during the delivery visit will be followed up to the 2-month well child visit.
All-cause mortality, serious adverse events, and other AEs exceeding a frequency threshold of 5% were collected and reported.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place