Safety and Immunogenicity of Simultaneous Tdap and IIV in... | NCT02783170

NCT02783170

Status Module

Sponsor/Collaborators Module

Name	Class
Children's Hospital Medical Center, Cincinnati	OTHER
Centers for Disease Control and Prevention	FED

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simultaneous vaccination arm	Other	In the study arm,subjects will receive both Tdap and IIV vaccines during study visit 1.	Biological: Tetanus, Diphtheria, and Pertussis Vaccine Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine Biological: 2017-2018 Quadrivalent Inactivated Influenza Vaccine
Sequential vaccination arm	Other	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.	Biological: Tetanus, Diphtheria, and Pertussis Vaccine Biological: 2016-2017 Quadrivalent Inactivated Influenza Vaccine Biological: 2017-2018 Quadrivalent Inactivated Influenza Vaccine

Name	Type	Description	Arm Group Labels	Other Names
Tetanus, Diphtheria, and Pertussis Vaccine	Biological		Sequential vaccination arm Simultaneous vaccination arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration	Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid	8 days post vaccine administration
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1	Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid	8 days post vaccine administration
Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4	Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid	8 days post vaccine administration
Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers	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	Pre-vaccination and approximately 21 days post vaccination and at Delivery
Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)	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	Pre vaccination and approximately 21 days post vaccination and at Delivery
Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Maternal Outcomes	The number of participants with adverse maternal outcomes at delivery. Missing data is data not collected or unavailable.	Up to the 6-week postpartum visit
Number of Participants With Adverse Infant Outcomes Based on Medical Record Review

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant, as determined by medical history; 18 - 45 years of age inclusive
Intention of receiving Tdap and IIV vaccines based on Advisory Committee on Immunization Practices (ACIP) recommendations
Willing to provide written informed consent prior to initiation of any study procedures
Singleton gestation ≥ 26 weeks 0 days gestation - ≤32 weeks 0 days gestation at the time of Visit 1 vaccination based on reconciliation of last menstrual period and ultrasound dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the ultrasound derived EDD is not in agreement with the LMP-derived EDD, the ultrasound-derived EDD is used to determine GA.
English or Spanish literate
Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of delivery information.

Exclusion Criteria:

For subjects enrolling during the 2016-2017 influenza season: IIV/LAIV receipt during 2016-2017 influenza season prior to study enrollment
For subjects enrolling during the 2017-2018 influenza season: IIV/LAIV receipt during 2017-2018 influenza season prior to study enrollment

2. Tdap/Td/TT receipt during current pregnancy prior to study enrollment 3. Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.

4. Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants (daily low dose aspirin may be acceptable).

5. Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.

6. Known to have pre-existing diabetes mellitus or an autoimmune disorder. 7. Febrile illness within the last 24 hours or an oral temperature >/= 100.4°F (>/= 38.0°C) prior to IIV or Tdap administration 8. Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein 9. Contraindication to Tdap receipt including history of severe allergic reaction after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause 10. Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine within the last 10 years 11. Any condition that may interfere with assessment of local injection site reactions, e.g. lymphadenectomy or obscuring tattoos 12. History of Guillain-Barré syndrome within 6 weeks of a prior dose of any tetanus toxoid-, diphtheria toxoid- or pertussis antigen-containing vaccine or influenza vaccine 13. Known or suspected impairment of immunologic function including infection with HIV, hepatitis B or C 14. Use of immunosuppressive or cytotoxic drugs except receipt of oral or parenteral (intravenous, subcutaneous or intramuscular) corticosteroids 30 or more days prior to enrollment. Persons who have used oral or parenteral corticosteroids within 12 months prior to enrollment may be enrolled if the longest course of therapy was less than 14 consecutive days and no dose was given within 30 days of enrollment. Intraarticular, bursal, tendon, or epidural injections of corticosteroids are permissible if the most recent injection was 30 or more days prior to enrolment. Persons applying topically corticosteroid in either upper arm (i.e. injection site) may be enrolled 1 or more days after their therapy is completed. Corticosteroids administered topically at non-injection sites, by inhalation or intranasally are permissible 15. Receipt of any licensed vaccine within 14 days prior to study vaccination or planning receipt of any vaccines (except study vaccines) prior to Visit 7 follow up.

16. Receipt of live vaccine during current pregnancy. 17. High risk for preterm birth (active preterm labor, short cervix, cervical cerclage, receipt of antenatal corticosteroids for fetal lung maturity prior to Visit 1) 18. Antenatal ultrasound diagnosis of fetal growth restriction, defined as < 10th percentile estimated fetal weight for gestational age 19. Known fetal congenital anomaly, e.g. genetic abnormality or malformation based on antenatal ultrasound 20. Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.

21. Anyone who is a relative of any research study personnel 22. Anyone who is an employee of any research study personnel 23. Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product. Co-enrollment in observational or behavioral intervention studies are allowed at any time.

24. Previous participation in the study.

Contacts/Locations Module

Name	Affiliation	Role
Geeta Swamy, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centers for Disease Control and Prevention		Atlanta	Georgia		United States
Duke University

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Sequential Vaccination Arm

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 5, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Sequential Vaccination Arm	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00042 BG00138 BG00280

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Median

Full Range

Years

Title

Denominators

Categories

Maternal Age

Title	Measurements
	BG00027(17 to 42) BG00125.5(18 to 39) BG00226(17 to 42)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00042 BG00138 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00042 BG00138 BG002

Recent Tdap Vaccine within 2 years

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0005 BG0015 BG002

Recent Flu Vaccine within 2 years

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0008 BG0017 BG002

Gestational Age in Weeks at Visit 1

Median

Full Range

Weeks

Title

Denominators

Categories

Title	Measurements
	BG00029.1(25.7 to 31.7) BG00128(24.3 to 31.4) BG002

Gestational Age in Weeks at Visit 4

Median

Full Range

Weeks

Title

Denominators

Categories

Title	Measurements
	BG00032.6(29.0 to 36.4) BG00131.9(27.4 to 35.4) BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration

Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid

Safety Population - subjects that were randomized and received the study intervention

Posted

Number

95% Confidence Interval

percentage of participants

8 days post vaccine administration

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG00042 OG00138

Title

Denominators

Categories

Flu Pain : None

- ParticipantsOG00040
- ParticipantsOG00137

Title	Measurements
	OG00047.5(31.5 to 63.9)

Primary

Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1

Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid

Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

Posted

Number

95% Confidence Interval

percentage of participants

8 days post vaccine administration

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Primary

Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4

Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid

Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

Posted

Number

95% Confidence Interval

percentage of participants

8 days post vaccine administration

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Primary

Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers

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

Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

Posted

Geometric Mean

95% Confidence Interval

Concentration (IU/mL)

Pre-vaccination and approximately 21 days post vaccination and at Delivery

ID	Title	Description
OG000	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
OG001	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

Units

Primary

Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)

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

Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.

Posted

Number

95% Confidence Interval

percentage of participants

Pre vaccination and approximately 21 days post vaccination and at Delivery

ID	Title	Description
OG000	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
OG001	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

Primary

Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)

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

Safety Population - all subjects receiving the study intervention. Participants analyzed include those that provided data.

Posted

Number

95% Confidence Interval

percentage of participants

21 days post vaccination

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Primary

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) )

Measurement of serum antibody levels to influenza antigens in maternal blood and infant cord blood obtained at delivery

Safety Population - subjects receiving the study intervention. Participants analyzed include those that provided data.

Posted

Number

95% Confidence Interval

percentage of participants

Pre and 21 days post vaccination and at Delivery

ID	Title	Description
OG000	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
OG001	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

Primary

Percentage of Subjects Recruited Enrollment Period

Percentage of subjects recruited during 4 month enrollment period

All subjects recruited and enrolled in the study

Posted

Number

percentage of participants

Approximately 1 year

ID	Title	Description
OG000	Recruited Subjects	In the study arm, this includes all subjects that were recruited and enrolled into the study.

Units	Counts
Participants	OG00081

Primary

Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits)

Percentage of participants that completed all in-person and delivery visits

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of participants

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Primary

Feasibility Reported as Percentage of Reactogenicity Data Collected

Percentage of reactogenicity data days reported (days reported / total possible days)

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of days

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Primary

Feasibility Reported as Percentage of Adequate Biospecimens Collected

Percentage of samples collected (sample timepoints collected / total possible sample timepoints)

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of samples

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Primary

Feasibility Reported as Percentage of Timely Collected Biospecimens

Timeliness is defined as collected within the visit window

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of samples

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With Adverse Maternal Outcomes

The number of participants with adverse maternal outcomes at delivery. Missing data is data not collected or unavailable.

Safety Population - subjects randomized and received study intervention

Posted

Count of Participants

Participants

Up to the 6-week postpartum visit

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With Adverse Infant Outcomes Based on Medical Record Review

Number of participants with adverse infant outcomes. Missing data is data not collected or unavailable.

Safety Population - subjects randomized and received study intervention

Posted

Count of Participants

Participants

approximately 2 months

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Percentage of Participants With Clinical Chorioamnionitis

Percentage of participants with clinical chorioamnionitis

Safety Population - subjects randomized and receiving study intervention

Posted

Number

percentage of participants

at the time of delivery

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue

Percentage of participants with histologic chorioamnionitis on surgical pathology examination of placental tissue

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of participants

after delivery, approximately up to 2 weeks

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Feasibility as Measured by Percentage of Blood Samples in Testable Condition

Percentage of blood samples received in testable condition (sufficient volume and quality)

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of samples

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing

Percentage of blood samples received with sufficient volume for testing

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of samples

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Feasibility as Measured by Percentage of Testable Blood Samples Completed

Percentage of testable (sufficient volume and quality) blood samples completed

Safety Population - subjects randomized and received study intervention

Posted

Number

percentage of samples

Approximately 1 year

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	42	1	42	2	42
EG001	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	0	38	0	38	2	38

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Uterine Rupture	Reproductive system and breast disorders		Systematic Assessment	Uterine rupture with cesarean delivery and hysterectomy. Assessed as unrelated to vaccine.	EG0001 events1 affected42 at risk EG0010 events0 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Congestion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment		EG0000 events0 affected42 at risk EG0012 events2 affected38 at risk
Headaches	General disorders		Systematic Assessment		EG0002 events2 affected42 at risk EG0010 events0 affected38 at risk

ID	Term
D007251	Influenza, Human
D014917	Whooping Cough

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

ID	Term
D015721	Diphtheria-Tetanus-Pertussis Vaccine
D007252	Influenza Vaccines

Ancestor Terms

ID	Term
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D014765	Viral Vaccines

OG00148.6(31.9 to 65.6)

Cannot be estimated - value is already 100%