Pregnancy
Conditions
Keywords
Tdap vaccine, Flu vaccine, vaccines in pregnancy, immunizations in pregnancy, Whooping Cough, Pertussis, Influenza
Brief summary
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the vaccines (IIV followed by Tdap \ 21 days later). Vaccines will be administered by licensed study personnel. Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when possible. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to the Tdap and Influenza at time points that include: prior to vaccination(s), \ 21 days post vaccination(s), and at delivery. Additionally, cord blood serum will be analyzed for the same antibody titers. Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained from medical record review.
Interventions
BIOLOGICALTetanus, Diphtheria, and Pertussis Vaccine
BIOLOGICAL2016-2017 Quadrivalent Inactivated Influenza Vaccine
BIOLOGICAL2017-2018 Quadrivalent Inactivated Influenza Vaccine
Sponsors
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant, as determined by medical history; 18 - 45 years of age inclusive 2. Intention of receiving Tdap and IIV vaccines based on Advisory Committee on Immunization Practices (ACIP) recommendations 3. Willing to provide written informed consent prior to initiation of any study procedures 4. 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. 5. English or Spanish literate 6. 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
1. For subjects enrolling during the 2016-2017 influenza season: IIV/LAIV receipt during 2016-2017 influenza season prior to study enrollment 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits) | Approximately 1 year | Percentage of participants that completed all in-person and delivery visits |
| Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | 8 days post vaccine administration | Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid |
| Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | 8 days post vaccine administration | Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid |
| Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-vaccination and approximately 21 days post vaccination and at Delivery | 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 |
| Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Pre vaccination and approximately 21 days post vaccination and at Delivery | 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 |
| Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | 21 days post vaccination | 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 |
| 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) ) | Pre and 21 days post vaccination and at Delivery | Measurement of serum antibody levels to influenza antigens in maternal blood and infant cord blood obtained at delivery |
| Percentage of Subjects Recruited Enrollment Period | Approximately 1 year | Percentage of subjects recruited during 4 month enrollment period |
| Feasibility Reported as Percentage of Reactogenicity Data Collected | Approximately 1 year | Percentage of reactogenicity data days reported (days reported / total possible days) |
| Feasibility Reported as Percentage of Timely Collected Biospecimens | Approximately 1 year | Timeliness is defined as collected within the visit window |
| Feasibility Reported as Percentage of Adequate Biospecimens Collected | Approximately 1 year | Percentage of samples collected (sample timepoints collected / total possible sample timepoints) |
| Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | 8 days post vaccine administration | Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | approximately 2 months | Number of participants with adverse infant outcomes. Missing data is data not collected or unavailable. |
| Percentage of Participants With Clinical Chorioamnionitis | at the time of delivery | Percentage of participants with clinical chorioamnionitis |
| Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue | after delivery, approximately up to 2 weeks | Percentage of participants with histologic chorioamnionitis on surgical pathology examination of placental tissue |
| Feasibility as Measured by Percentage of Blood Samples in Testable Condition | Approximately 1 year | Percentage of blood samples received in testable condition (sufficient volume and quality) |
| Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing | Approximately 1 year | Percentage of blood samples received with sufficient volume for testing |
| Feasibility as Measured by Percentage of Testable Blood Samples Completed | Approximately 1 year | Percentage of testable (sufficient volume and quality) blood samples completed |
| Number of Participants With Adverse Maternal Outcomes | Up to the 6-week postpartum visit | The number of participants with adverse maternal outcomes at delivery. Missing data is data not collected or unavailable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 42 |
| 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 | 38 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Randomized but not Vaccinated | 1 | 0 |
Baseline characteristics
| Characteristic | Sequential Vaccination Arm | Total | Simultaneous Vaccination Arm |
|---|---|---|---|
| Age, Customized Maternal Age | 25.5 Years | 26 Years | 27 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 67 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Gestational Age in Weeks at Visit 1 | 28 Weeks | 28.7 Weeks | 29.1 Weeks |
| Gestational Age in Weeks at Visit 4 | 31.9 Weeks | 32.3 Weeks | 32.6 Weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 34 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 39 Participants | 22 Participants |
| Recent Flu Vaccine within 2 years | 7 Participants | 15 Participants | 8 Participants |
| Recent Tdap Vaccine within 2 years | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 38 Participants | 80 Participants | 42 Participants |
| Sex: Female, Male Female | 38 Participants | 80 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 38 |
| other Total, other adverse events | 2 / 42 | 2 / 38 |
| serious Total, serious adverse events | 1 / 42 | 0 / 38 |
Outcome results
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
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits) | 98.6 percentage of participants |
| Sequential Vaccination Arm | Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits) | 97.7 percentage of participants |
Primary
Feasibility Reported as Percentage of Adequate Biospecimens Collected
Percentage of samples collected (sample timepoints collected / total possible sample timepoints)
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility Reported as Percentage of Adequate Biospecimens Collected | 94.0 percentage of samples |
| Sequential Vaccination Arm | Feasibility Reported as Percentage of Adequate Biospecimens Collected | 95.4 percentage of samples |
Primary
Feasibility Reported as Percentage of Reactogenicity Data Collected
Percentage of reactogenicity data days reported (days reported / total possible days)
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility Reported as Percentage of Reactogenicity Data Collected | 92.6 percentage of days |
| Sequential Vaccination Arm | Feasibility Reported as Percentage of Reactogenicity Data Collected | 93.1 percentage of days |
Primary
Feasibility Reported as Percentage of Timely Collected Biospecimens
Timeliness is defined as collected within the visit window
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility Reported as Percentage of Timely Collected Biospecimens | 94.0 percentage of samples |
| Sequential Vaccination Arm | Feasibility Reported as Percentage of Timely Collected Biospecimens | 95.4 percentage of samples |
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
Time frame: 8 days post vaccine administration
Population: Safety Population - subjects that were randomized and received the study intervention
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : None | 55.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : Mild | 37.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : Moderate | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : None | 32.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : Mild | 55.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : Moderate | 12.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : None | 47.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : Mild | 30.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : Moderate | 10.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : Severe | 5.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : None | 37.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : Mild | 37.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : Moderate | 22.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : Severe | 2.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : None | 92.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : Mild | 7.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : None | 92.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : Mild | 7.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : None | 85.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : Mild | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : None | 82.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : Mild | 17.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : None | 48.6 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : None | 83.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : Mild | 45.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : None | 82.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : Moderate | 5.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : Mild | 13.5 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Pain : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : None | 85.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : None | 54.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : Moderate | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : Mild | 37.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : Mild | 11.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : Moderate | 8.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Redness : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Tenderness : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : Moderate | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : None | 70.6 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : None | 89.2 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : Mild | 14.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : Moderate | 5.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : Moderate | 14.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : Mild | 8.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Pain : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Swelling : Mild | 11.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : None | 50.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : Moderate | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : Mild | 17.6 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Redness : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : Moderate | 29.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Flu Swelling : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration | Tdap Tenderness : Severe | 2.9 percentage of participants |
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
Time frame: 8 days post vaccine administration
Population: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : None | 85.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : None | 100.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : Mild | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : None | 90.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : Mild | 7.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : Moderate | 2.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : None | 65.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : Mild | 20.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : Moderate | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : None | 90.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : Mild | 5.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : Moderate | 2.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : Severe | 2.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : None | 90.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : Mild | 5.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : Moderate | 5.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : None | 87.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : Mild | 10.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : Moderate | 2.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : None | 65.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : Mild | 20.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : Moderate | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : None | 70.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : Mild | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : Moderate | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : None | 82.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : Mild | 15.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : Moderate | 2.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : None | 87.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : Mild | 7.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : Moderate | 5.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : Mild | 5.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : Moderate | 10 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : Mild | 10.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : None | 94.6 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : Mild | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : Mild | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fever : Severe | 5.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : None | 97.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : None | 78.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : Mild | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : Moderate | 5.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : Mild | 16.2 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Abdominal Pain : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : None | 78.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : Moderate | 5.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : Mild | 18.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : Moderate | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Fatigue : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Aches : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : None | 97.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : None | 97.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : None | 75.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : Mild | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : None | 89.2 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : Moderate | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : Mild | 18.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Body Rash : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : None | 91.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : Moderate | 5.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : Mild | 8.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Nausea : Mild | 10.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Headache : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Chills Shivering : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Vomiting : Mild | 2.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Diarrhea : None | 89.2 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1 | Joint Pain : None | 91.9 percentage of participants |
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
Time frame: 8 days post vaccine administration
Population: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : Moderate | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : Mild | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : None | 84.2 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : Severe | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : Mild | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : Mild | 5.3 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : None | 100.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : Moderate | 10.5 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : Mild | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : Moderate | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : None | 92.1 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : Mild | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : Moderate | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : Severe | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : None | 100.0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : None | 94.7 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : Mild | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : None | 97.4 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : Mild | 5.3 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : None | 92.1 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : None | 94.7 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : Mild | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : None | 97.4 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : Moderate | 2.6 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : Mild | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : None | 94.7 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : None | 97.4 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : Mild | 5.3 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : Moderate | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : Mild | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : Severe | 0 percentage of participants |
| Simultaneous Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : Moderate | 5.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : Severe | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : None | 100.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : Mild | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fever : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : None | 100.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : Mild | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Abdominal Pain : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : None | 82.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : Mild | 11.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : Moderate | 5.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Aches : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : Mild | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : None | 97.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : Mild | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Chills Shivering : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : None | 97.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : Mild | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : Moderate | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Diarrhea : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : None | 85.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : Mild | 11.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : Moderate | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Fatigue : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : None | 79.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : Mild | 14.7 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : Moderate | 5.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Headache : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : None | 94.1 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : Mild | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : Moderate | 5.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Joint Pain : Severe | 0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : None | 82.4 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : Mild | 8.8 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : Moderate | 5.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Nausea : Severe | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : None | 91.2 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : Mild | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Vomiting : Moderate | 2.9 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4 | Body Rash : None | 100.0 percentage of participants |
Primary
Percentage of Subjects Recruited Enrollment Period
Percentage of subjects recruited during 4 month enrollment period
Time frame: Approximately 1 year
Population: All subjects recruited and enrolled in the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Percentage of Subjects Recruited Enrollment Period | 100.0 percentage of participants |
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
Time frame: Pre vaccination and approximately 21 days post vaccination and at Delivery
Population: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Cord Blood | 100.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Pre-Vaccination | 76.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Maternal Blood | 100.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Post-Vaccination | 100 percentage of participants |
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
Time frame: Pre and 21 days post vaccination and at Delivery
Population: Safety Population - subjects receiving the study intervention. Participants analyzed include those that provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Sequential Vaccination Arm | 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 | 78.1 percentage of participants |
| Sequential Vaccination Arm | 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 | 71.1 percentage of participants |
| Sequential Vaccination Arm | 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 | 81.6 percentage of participants |
| Sequential Vaccination Arm | 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 | 94.7 percentage of participants |
| Sequential Vaccination Arm | 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 |
| Sequential Vaccination Arm | 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 | 50.0 percentage of participants |
| Sequential Vaccination Arm | 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 | 42.1 percentage of participants |
| Sequential Vaccination Arm | 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 | 60.5 percentage of participants |
| Sequential Vaccination Arm | 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 | 87.5 percentage of participants |
| Sequential Vaccination Arm | 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 | 92.1 percentage of participants |
| Sequential Vaccination Arm | 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 | 94.6 percentage of participants |
| Sequential Vaccination Arm | 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 | 65.8 percentage of participants |
| Sequential Vaccination Arm | 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 | 51.4 percentage of participants |
| Sequential Vaccination Arm | 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 | 13.2 percentage of participants |
| Sequential Vaccination Arm | 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 | 93.8 percentage of participants |
| Sequential Vaccination Arm | 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 | 63.2 percentage of participants |
| Sequential Vaccination Arm | 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 | 67.6 percentage of participants |
| Sequential Vaccination Arm | 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 | 50.0 percentage of participants |
| Sequential Vaccination Arm | 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 | 94.6 percentage of participants |
| Sequential Vaccination Arm | 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 | 47.4 percentage of participants |
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
Time frame: 21 days post vaccination
Population: Safety Population - all subjects receiving the study intervention. Participants analyzed include those that provided data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Simultaneous Vaccination Arm | 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 |
| Sequential Vaccination Arm | 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 |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Post-Vaccination | 100 percentage of participants |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Maternal Blood | 97.3 percentage of participants |
| Sequential Vaccination Arm | Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL) | Pre-Vaccination | 84.2 percentage of participants |
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
Time frame: Pre-vaccination and approximately 21 days post vaccination and at Delivery
Population: Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - FHA | 27.5 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - FIM | 87.3 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - PRN | 44.8 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - PT | 7.8 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - FHA | 171.3 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - FIM | 99.9 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - PRN | 242.1 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - PT | 37.6 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - FHA | 118.3 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - FIM | 81.2 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - PRN | 174.1 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - PT | 26.8 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - FHA | 182 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - FIM | 122.2 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - PRN | 245.4 Concentration (IU/mL) |
| Simultaneous Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - PT | 46 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - PT | 43.4 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - FHA | 37.0 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - FHA | 199.8 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - FIM | 20.8 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - FHA | 265.6 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - PRN | 47.1 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - FIM | 18.9 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Pre-Vaccination - PT | 5.9 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - PRN | 352.1 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - FHA | 262.1 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - PRN | 297.1 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - FIM | 19.7 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Cord Blood - FIM | 32.2 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - PRN | 360.4 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Maternal - PT | 27.9 Concentration (IU/mL) |
| Sequential Vaccination Arm | Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers | Post-Vaccination - PT | 38.6 Concentration (IU/mL) |
Secondary
Feasibility as Measured by Percentage of Blood Samples in Testable Condition
Percentage of blood samples received in testable condition (sufficient volume and quality)
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility as Measured by Percentage of Blood Samples in Testable Condition | 100.0 percentage of samples |
| Sequential Vaccination Arm | Feasibility as Measured by Percentage of Blood Samples in Testable Condition | 100.0 percentage of samples |
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
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing | 100.0 percentage of samples |
| Sequential Vaccination Arm | Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing | 100.0 percentage of samples |
Secondary
Feasibility as Measured by Percentage of Testable Blood Samples Completed
Percentage of testable (sufficient volume and quality) blood samples completed
Time frame: Approximately 1 year
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Feasibility as Measured by Percentage of Testable Blood Samples Completed | 100.0 percentage of samples |
| Sequential Vaccination Arm | Feasibility as Measured by Percentage of Testable Blood Samples Completed | 100.0 percentage of samples |
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.
Time frame: approximately 2 months
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Neonatal Death | Yes | 0 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Jaundice Requiring Phototherapy | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hypoglycemia | No | 41 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Transient Tachypnea | Yes | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Small Gestational Age (SGA): Olsen et al. | No | 40 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Transient Tachypnea | No | 40 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hypoglycemia | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Transient Tachypnea | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Neonatal Death | No | 41 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hematological | Yes | 0 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Respiratory | Yes | 0 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hematological | No | 41 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Small Gestational Age (SGA): Olsen et al. | Missing | 0 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hematological | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Respiratory | No | 41 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Sepsis/Rule out Infection | Yes | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Neonatal Death | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Sepsis/Rule out Infection | No | 40 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Respiratory | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Sepsis/Rule out Infection | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Jaundice Requiring Phototherapy | Yes | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Low Birth Weight (< 2500 g) | Yes | 3 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hypoglycemia | Yes | 0 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Low Birth Weight (< 2500 g) | No | 38 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Jaundice Requiring Phototherapy | No | 40 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Low Birth Weight (< 2500 g) | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Small Gestational Age (SGA): Olsen et al. | Yes | 2 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Low Birth Weight (< 2500 g) | Missing | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Small Gestational Age (SGA): Olsen et al. | Yes | 4 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Small Gestational Age (SGA): Olsen et al. | No | 34 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Small Gestational Age (SGA): Olsen et al. | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Neonatal Death | Yes | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Neonatal Death | No | 38 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Neonatal Death | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hypoglycemia | Yes | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hypoglycemia | No | 37 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hypoglycemia | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Respiratory | Yes | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Respiratory | No | 37 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Respiratory | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Jaundice Requiring Phototherapy | Yes | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Jaundice Requiring Phototherapy | No | 37 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Jaundice Requiring Phototherapy | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Transient Tachypnea | Yes | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Transient Tachypnea | No | 38 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Transient Tachypnea | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hematological | Yes | 2 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hematological | No | 36 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Hematological | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Sepsis/Rule out Infection | Yes | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Sepsis/Rule out Infection | No | 37 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Sepsis/Rule out Infection | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Low Birth Weight (< 2500 g) | Yes | 2 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Infant Outcomes Based on Medical Record Review | Low Birth Weight (< 2500 g) | No | 35 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.
Time frame: Up to the 6-week postpartum visit
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Diabetes | No | 35 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Hypertension | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Pre-term Birth (<37 weeks) | No | 38 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Preeclampsia | Yes | 3 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Diabetes | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Preeclampsia | No | 38 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Diabetes | Yes | 6 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Preeclampsia | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Hypertension | Yes | 5 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Severe Preeclampsia/HELLP | Yes | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Pre-term Birth (<37 weeks) | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Severe Preeclampsia/HELLP | No | 40 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Hypertension | No | 36 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Severe Preeclampsia/HELLP | Missing | 1 Participants |
| Simultaneous Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Pre-term Birth (<37 weeks) | Yes | 3 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Severe Preeclampsia/HELLP | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Pre-term Birth (<37 weeks) | Yes | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Pre-term Birth (<37 weeks) | No | 37 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Pre-term Birth (<37 weeks) | Missing | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Diabetes | Yes | 3 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Diabetes | No | 35 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Diabetes | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Hypertension | Yes | 7 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Hypertension | No | 31 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Gestational Hypertension | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Preeclampsia | Yes | 1 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Preeclampsia | No | 37 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Preeclampsia | Missing | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Severe Preeclampsia/HELLP | Yes | 0 Participants |
| Sequential Vaccination Arm | Number of Participants With Adverse Maternal Outcomes | Severe Preeclampsia/HELLP | No | 38 Participants |
Secondary
Percentage of Participants With Clinical Chorioamnionitis
Percentage of participants with clinical chorioamnionitis
Time frame: at the time of delivery
Population: Safety Population - subjects randomized and receiving study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Percentage of Participants With Clinical Chorioamnionitis | 0.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Clinical Chorioamnionitis | 0.0 percentage of 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
Time frame: after delivery, approximately up to 2 weeks
Population: Safety Population - subjects randomized and received study intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Simultaneous Vaccination Arm | Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue | 19.0 percentage of participants |
| Sequential Vaccination Arm | Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue | 15.8 percentage of participants |