Respiratory Syncytial Virus Infections
Conditions
Keywords
RSV
Brief summary
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.
Detailed description
This is a randomized, observer-blind, placebo-controlled trial enrolling third-trimester pregnant women in the Northern and Southern hemispheres, for up to four consecutive RSV seasons in each hemisphere. The trial could enroll up to 8618 third-trimester pregnant subjects, of which 4,636 were actually enrolled. Women in the third trimester of a singleton uncomplicated low-risk pregnancy and 18 to 40 years of age (inclusive) were enrolled and randomized in a 1:1 ratio into one of two treatment groups, active or placebo, over approximately three months prior to peak RSV season in their locale. After the first global season of enrollment, the randomization scheme was changed to a 2:1 (active/placebo) ratio to enable a more efficient accrual of the safety database. All maternal subjects were to receive a single intramuscular (IM) injection on Day 0 with the assigned test article, the RSV F vaccine, or placebo. Study participation for maternal subjects spanned approximately nine (9) months from the first dose, ending six (6) months post-delivery. Study follow-up for live-born infant subjects spanned approximately one (1) year post-delivery.
Interventions
BIOLOGICALRSV F vaccine with adjuvant
BIOLOGICALFormulation buffer
Sponsors
Bill and Melinda Gates Foundation
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. ≥18 and ≤40 years-of-age 2. Singleton pregnancy of 28 to 36 0/7 weeks gestation on the day of planned vaccination * Documentation of gestational age will be based on one of the following composite criteria. (Note: The Investigator was to use the earliest ultrasound data available to establish the study-specific gestational age dating): 1. Gestational Age Dating Based on First Trimester Data (data obtained ≤13 6/7 weeks): The date of the first day of the reported last menstrual period (LMP) may be used to establish the gestational age if corroborated by a first trimester ultrasound. If the gestational age estimation derived using the LMP and the first trimester ultrasound are discrepant \>7 days, the ultrasound will be used to establish gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy. 2. Gestational Age Dating Based on Early Second Trimester Data (data obtained 14 0/7 to 21 6/7 weeks): The day of the first reported LMP may be used to establish the gestational age if corroborated by an early second trimester ultrasound (that estimates the gestational age between 14 0/7 and 21 6/7 weeks). If the gestational age estimation derived using the LMP and the early second trimester ultrasound are discrepant \>10 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy. 3. Gestation Age Dating Based on Later Second Trimester Data (data obtained 22 0/7 and 27 6/7 weeks by LMP): The date of the first day of the reported LMP may be used to establish the gestation age if corroborated by a later second trimester ultrasound (that estimates the gestational age between 22 0/7 and 27 6/7 weeks). If the gestational age estimation derived using the LMP and the later second trimester ultrasound are discrepant \>14 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy. 4. Gestational Age Dating When the LMP is Uncertain or Unknown AND No Prior First or Second Trimester Ultrasound Has Been Performed: An ultrasound performed at screening within the second trimester (≤27 6/7 weeks) will be used to establish the gestational age of the pregnancy. 3. Documentation of a second or third (between 18 0/7 weeks and prior to randomization) trimester ultrasound with no major fetal anomalies identified. 4. Good general maternal health as demonstrated by: * Medical history (including history of adverse reactions to prior vaccines and allergies). * Physical examination including at least vital signs (blood pressure, pulse, respirations, and oral temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones. Note that abnormal vital signs may be repeated at the investigator's discretion since these measures may be labile. Vital signs should be assessed in the context of normal values for the third trimester of pregnancy (see the Study Operations Manual). * Clinical laboratory parameters that include: * For the first year of study conduct in any country, normal/clinically insignificant blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count. Note that normal ranges for clinical laboratory parameters will be based on reference ranges appropriate for the subject population under study (i.e., third trimester of pregnancy) and as defined in the toxicity grading scale (TGS) (see the Study Operations Manual). * For all subjects, serologic exclusion of infection with hepatitis B (HBV) and C (HCV) viruses, syphilis, and HIV as documented by testing (performed at the central or local laboratory) at screening or by medical records during the current pregnancy. 5. Able to understand, and both willing and physically able to comply with study procedures. This includes anticipation of reasonable geographic proximity to the study clinic and adequate transportation to comply with scheduled and unscheduled study follow-up visits. 6. Able and willing to provide written informed consent for themselves and infant.
Exclusion criteria
1. Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose \>500µg per day of beclomethasone or fluticasone, or \>800μg per day of budesonide. 2. Pregnancy complications (in the current pregnancy) such as preterm labor, hypertension (blood pressure \[BP\] \>140/90 in the presence of proteinuria or BP \>150/100 with or without proteinuria) or currently on an antihypertensive therapy or pre-eclampsia; or evidence of intrauterine growth restriction. 3. Grade 2 or higher clinical laboratory or vital sign abnormality. Exclusion of subjects with grade 1 abnormalities will be based on the subject's prior medical history and the investigator's clinical judgment that the abnormality is indicative of a meaningful physiologic event. 4. Receipt of any licensed vaccine (e.g., Tdap, inactivated influenza vaccine) within 14 days of study vaccination. 5. Received any RSV vaccine at any time. 6. Body mass index (BMI) of ≥40, at the time of the screening visit. 7. Hemoglobinopathy (even if asymptomatic) or blood dyscrasias. 8. Hepatic or renal dysfunction. 9. Established diagnosis of seizure disorder, regardless of therapy. 10. Known, active auto-immune disease or immunodeficiency syndrome. 11. Endocrine disorders, including (but not limited to) untreated hyperthyroidism, untreated hypothyroidism (unless due to auto-immune disease), and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control. 12. History of major gynecologic or major abdominal surgery, including bariatric surgery (previous Caesarean section is not an exclusion). 13. Known HIV, syphilis, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study. 14. Primary genital Herpes simplex virus (HSV) infection during the current pregnancy. 15. Current alcohol or drug abuse based on the Investigator's knowledge of present or recent (within the last 2 years) use/abuse of alcohol or illegal or non-prescription drugs. 16. Documentation that the current pregnancy results from in vitro fertilization (IVF). 17. Documentation that the current pregnancy results from rape or incest. 18. Documentation that the infant will be a ward of the state or be released for adoption. 19. History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy (the use of low-dose aspirin as prophylaxis \[e.g., for the prevention of morbidity and mortality from preeclampsia\] is acceptable is dosages consistent with local standards of care). 20. Red blood cell allo-immunization. 21. Prior stillbirth or neonatal death, or multiple (≥3) spontaneous abortions. 22. Prior preterm delivery ≤34 weeks gestation or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm birth. 23. Greater than five (5) prior deliveries. 24. Previous infant with a known genetic disorder or major congenital anomaly. 25. Receipt of investigational drugs or immune globulins (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to the administration of the study vaccine. 26. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted except for the limit established in exclusion criterion #1. 27. Neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs (excluding treatment for depression and anxiety). 28. Any other physical, psychiatric or social condition which may, in the investigator's opinion, increase the risks of study participation to the maternal subject or the fetus/infant; or may lead to the collection of incomplete or inaccurate safety data. 29. Acute disease within 72 hours of the day of the planned vaccination (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C). 30. History of a serious adverse reactions (e.g., anaphylaxis) to any prior vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Delivery to 180 days after delivery | Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120,150, and 180 days of life, as defined by: * The presence of RSV infection confirmed by detection of RSV genome by RT-PCR on respiratory secretions (obtained within the continuous illness episode which fulfills the other criteria listed below); AND * At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea; AND * Evidence of medical significance as defined by the presence of: * EITHER hypoxemia (peripheral oxygen saturation \[SpO2\] \< 95% at sea level or \< 92% at altitudes \> 1800 meters) OR * Tachypnea (≥ 70 breaths per minute \[bpm\] in infants 0 to 59 days of age and ≥ 60 bpm in infants ≥ 60 days of age). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Delivery to 180 days after delivery | Percentages of infants with RSV LRTI with hospitalization from delivery through 90, 120, 150, and 180 days of life. |
| Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Delivery to 364 days after delivery | Number of infants with AEs and SAEs (with special attention to congenital anomalies; respiratory failure other than RSV-associated hospitalization; neonatal death; infant death; sudden infant death syndrome; asphyxia; neonatal or hypoxic-ischemic encephalopathy; or other adverse events or complications of adverse events that necessitate hospitalization) during the neonatal period and through the first year of life. |
| Infants: Number of Participants With Potential Developmental Delay | Day 180 after delivery | Number of infants with potential developmental delay (a term used to describe a delay in a child's development), as measured by the outcome of testing with the Ages and Stages Questionnaire-3 at 6 months and at 1 year, in infants of RSV F vaccinees as compared to placebo. |
| Maternal: Number of Participants With Solicited Injection Site and Systemic Reactogenicity | Day 0 to Day 7 | A number of maternal participants with solicited injection site and systemic reactogenicity within seven days of vaccination. |
| Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | Delivery to 180 days after delivery | Number of maternal participants with unsolicited (local and systemic) adverse events (AEs), unscheduled medically-attended adverse events (MAEs), significant new medical conditions (SNMCs), and serious adverse events (SAEs) through delivery and six (6) months thereafter. |
| Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Delivery | Number of maternal subjects that had either Caesarean, vaginal, or instrument-assisted vaginal modes of delivery. |
| Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 to Delivery | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery |
| Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 to Delivery | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery |
| Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 to Delivery | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery |
| Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 to Delivery | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery |
| Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery to Day 180 | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Infant Participants from Delivery until Day 180 |
| Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Delivery to 180 days after delivery | The number of infants with RSV LRTI with EITHER severe hypoxemia (SpO2 \< 92% at sea level or \< 87% at altitudes \> 1800 meters) OR the documented use of oxygen by high flow nasal cannula OR CPAP OR BiPAP OR Bubble CPAP OR bag-mask ventilation OR intubation with subsequent mechanical (or manual) ventilation OR ECMO from delivery through 90, 120, 150, and 180 days of life. |
| Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 to Day 180 | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Infant Participants from Day 14 until Day 180 |
| Infants: Mean Length of Participants at Birth | At Delivery | Length of Infant participants measured at delivery expressed in centimeters |
| Infants: Mean Weight of Participants at Birth | At Delivery | Weight of infant participants measured at delivery expressed in kilograms. |
| Infants: Mean Frontal-occipital Head Circumference of Participants at Birth | At Delivery | Frontal-occipital Head Circumference measured in infant participants at delivery expressed as centimeters |
| Infants: Mean APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Score of Participants at Birth | At Delivery | The APGAR test measures the infant's Appearance, Pulse, Grimace, Activity, and Respiration. Any score of 7 or above is considered a good APGAR score. The maximum APGAR score is 10 and the minimum score is 1. |
| Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | Day 0 to Delivery | Number of maternal participants with post-immunization onset of specific complications of third-trimester pregnancy and delivery including Pregnancy complications, Labor and delivery complications. |
| Infants: Number of Participants With Developmental Delay | Day 364 after delivery | Number of infants with developmental delay (a term used to describe a delay in a child's development.), as measured by the outcome of testing at 1 year, in infants of RSV F vaccinees as compared to placebo. |
| Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Pre-dose to Delivery +180 days | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG) among Maternal Participants from Screening until Delivery |
| Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Pre-dose to Delivery +180 days | Immunogenicity of RSV F Vaccine and Placebo (Palivizumab-competitive antibodies (PCA)) among Maternal Participants from Screening until Delivery |
| Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Pre-dose to Delivery +180 days | Immunogenicity of RSV F Vaccine and Placebo (RSV/A microneutralization titers expressed as GMT) among Maternal Participants from Screening until Delivery |
| Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Pre-dose to Delivery +180 days | Immunogenicity of RSV F Vaccine and Placebo (RSV/B microneutralization titers expressed as GMT) among Maternal Participants from Screening until Delivery |
| Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery to Day 180 | Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Infant Participants from Delivery until Day 180 |
Countries
Argentina, Australia, Bangladesh, Chile, Mexico, New Zealand, Philippines, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants took part in a study at 86 sites in 11 different countries from 03 December 2015 to 12 July 2019.
Pre-assignment details
Healthy women 18-40 years of age with low-risk singleton pregnancies enrolled and treated in the study with 120 µg Respiratory Syncytial Virus Recombinant F (RSVF) nanoparticle vaccine adsorbed to 0.4 mg of Aluminum (as phosphate salt) ) or formulated buffer (placebo control) as a single 0.5 mL IM (Intramuscular) injection into the deltoid muscle.
Participants by arm
| Arm | Count |
|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) Maternal participants were administered the adjuvant RSV F vaccine (120 µg RSV F protein adsorbed to a 0.4 mg dose of aluminum as the phosphate salt) as a single 0.5 mL IM injection into the deltoid muscle.
Infants were monitored and data was collected based on the intervention given to the mothers. | 3,045 |
| Formulated Buffer (Placebo Control) Maternal participants were administered the formulated buffer (placebo control) as a single 0.5 mL IM injection into the deltoid muscle. Infants were monitored and data was collected based on the intervention given to the mothers. | 1,581 |
| Total | 4,626 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Infant Participants | Adverse Event | 18 | 11 |
| Infant Participants | Investigator Decision | 5 | 4 |
| Infant Participants | Lost to Follow-up | 93 | 58 |
| Infant Participants | Miscellaneous | 50 | 26 |
| Infant Participants | Non Compliance | 17 | 7 |
| Infant Participants | Sponsor Request | 0 | 1 |
| Infant Participants | Voluntary Withdrawal unrelated to AE | 48 | 25 |
| Maternal Participants | Adverse Event | 5 | 0 |
| Maternal Participants | Investigator Decision | 5 | 3 |
| Maternal Participants | Lost to Follow-up | 54 | 24 |
| Maternal Participants | Miscellaneous | 23 | 15 |
| Maternal Participants | Non Compliance | 8 | 5 |
| Maternal Participants | Sponsor Request | 1 | 1 |
| Maternal Participants | Voluntary withdrawal unrelated to AE | 48 | 27 |
Baseline characteristics
| Characteristic | Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Formulated Buffer (Placebo Control) | Total |
|---|---|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 5.3 | 26 years STANDARD_DEVIATION 5.2 | 26 years STANDARD_DEVIATION 5.3 |
| Age, Customized Gestational Age at delivery (Infant Population) | 39.3 weeks STANDARD_DEVIATION 1.49 | 39.3 weeks STANDARD_DEVIATION 1.58 | 39.3 weeks STANDARD_DEVIATION 1.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 409 Participants | 212 Participants | 621 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2636 Participants | 1369 Participants | 4005 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 21 Participants | 9 Participants | 30 Participants |
| Race/Ethnicity, Customized Asian | 310 Participants | 162 Participants | 472 Participants |
| Race/Ethnicity, Customized Black or African American | 1387 Participants | 696 Participants | 2083 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 403 Participants | 213 Participants | 616 Participants |
| Race/Ethnicity, Customized Na data | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 55 Participants | 28 Participants | 83 Participants |
| Race/Ethnicity, Customized No data | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 2603 Participants | 1346 Participants | 3949 Participants |
| Race/Ethnicity, Customized Other | 333 Participants | 187 Participants | 520 Participants |
| Race/Ethnicity, Customized White or Caucasian | 900 Participants | 477 Participants | 1377 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 22 Participants | 11 Participants | 33 Participants |
| Race (NIH/OMB) Asian | 320 Participants | 168 Participants | 488 Participants |
| Race (NIH/OMB) Black or African American | 1335 Participants | 682 Participants | 2017 Participants |
| Race (NIH/OMB) More than one race | 416 Participants | 204 Participants | 620 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 49 Participants | 27 Participants | 76 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 903 Participants | 489 Participants | 1392 Participants |
| Sex/Gender, Customized Female | 1449 Participants | 1581 Participants | 4626 Participants |
| Sex/Gender, Customized Male | 1556 Participants | 799 Participants | 2355 Participants |
| Sex/Gender, Customized No data | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,045 | 0 / 1,581 | 0 / 3,008 | 0 / 1,561 |
| other Total, other adverse events | 361 / 4,636 | 185 / 4,636 | 3,167 / 4,569 | 1,598 / 4,569 |
| serious Total, serious adverse events | 1,356 / 3,045 | 684 / 1,581 | 2,535 / 3,008 | 1,396 / 1,561 |
Outcome results
Primary
Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea
Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120,150, and 180 days of life, as defined by: * The presence of RSV infection confirmed by detection of RSV genome by RT-PCR on respiratory secretions (obtained within the continuous illness episode which fulfills the other criteria listed below); AND * At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea; AND * Evidence of medical significance as defined by the presence of: * EITHER hypoxemia (peripheral oxygen saturation \[SpO2\] \< 95% at sea level or \< 92% at altitudes \> 1800 meters) OR * Tachypnea (≥ 70 breaths per minute \[bpm\] in infants 0 to 59 days of age and ≥ 60 bpm in infants ≥ 60 days of age).
Time frame: Delivery to 180 days after delivery
Population: Analysis population includes infant participants who were ≥ 37 weeks GA at birth, and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery, and had not received prophylactic treatment with palivizumab between birth and Day 180 after delivery, and had at least 1 documented post-partum contact during which active and/or passive surveillance activities for RSV-suspect illness could occur.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 180 | 61 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 90 | 41 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 120 | 52 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 150 | 57 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 150 | 43 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 180 | 43 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 120 | 41 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea | Day 90 | 35 Participants |
Secondary
Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Infant Participants from Delivery until Day 180
Time frame: Delivery to Day 180
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (PCA) | 17 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (Anti-F IgG) | 690 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (PCA) | 8 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (MN - RSV/A) | 1108 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (MN - RSV/A) | 1705 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (Anti-F IgG) | 289 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (MN - RSV/A) | 609 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (Anti-F IgG) | 3883 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (MN - RSV/A) | 370 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (PCA) | 136 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (MN - RSV/A) | 201 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (Anti-F IgG) | 9501 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (MN - RSV/A) | 110 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (PCA) | 103 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (MN - RSV/A) | 41 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (Anti-F IgG) | 2355 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (MN - RSV/B) | 1292 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (PCA) | 69 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (MN - RSV/B) | 1079 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (MN - RSV/B) | 422 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (MN - RSV/B) | 216 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (PCA) | 45 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (MN - RSV/B) | 185 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (Anti-F IgG) | 1298 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (MN - RSV/B) | 71 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (PCA) | 29 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (MN - RSV/B) | 34 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (Anti-F IgG) | 6465 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (MN - RSV/B) | 24 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (MN - RSV/B) | 195 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (Anti-F IgG) | 752 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (Anti-F IgG) | 543 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (Anti-F IgG) | 324 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (Anti-F IgG) | 242 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (Anti-F IgG) | 216 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (Anti-F IgG) | 218 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (Anti-F IgG) | 218 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (PCA) | 15 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (PCA) | 12 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (PCA) | 8 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (PCA) | 7 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (PCA) | 6 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (PCA) | 6 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (PCA) | 6 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (MN - RSV/A) | 505 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 35 (MN - RSV/A) | 266 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (MN - RSV/A) | 190 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (MN - RSV/A) | 109 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (MN - RSV/A) | 61 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 180 (MN - RSV/A) | 26 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (MN - RSV/B) | 607 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 14 (MN - RSV/B) | 324 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 60 (MN - RSV/B) | 151 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 90 (MN - RSV/B) | 61 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Day 112/120 (MN - RSV/B) | 48 percentage of participants |
| Formulated Buffer (Placebo Control) | Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT | Delivery (MN - RSV/A) | 732 percentage of participants |
Secondary
Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Infant Participants from Day 14 until Day 180
Time frame: Day 14 to Day 180
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (PCA) | 0.76 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (Anti-F IgG) | 0.67 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (Anti-F IgG) | 0.42 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (Anti-F IgG) | 0.24 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (Anti-F IgG) | 0.13 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (Anti-F IgG) | 0.07 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (Anti-F IgG) | 0.03 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (PCA) | 0.51 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (PCA) | 0.34 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (PCA) | 0.21 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (PCA) | 0.12 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (PCA) | 0.06 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (MN - RSV/A) | 0.68 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (MN - RSV/A) | 0.39 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (MN - RSV/A) | 0.21 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (MN - RSV/A) | 0.13 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (MN - RSV/A) | 0.08 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (MN - RSV/A) | 0.03 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (MN - RSV/B) | 0.55 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (MN - RSV/B) | 0.39 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (MN - RSV/B) | 0.17 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (MN - RSV/B) | 0.11 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (MN - RSV/B) | 0.07 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (MN - RSV/B) | 0.03 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (MN - RSV/B) | 0.08 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (MN - RSV/A) | 0.69 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (Anti-F IgG) | 0.69 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (MN - RSV/B) | 0.66 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (Anti-F IgG) | 0.44 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (MN - RSV/A) | 0.40 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (MN - RSV/B) | 0.16 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (Anti-F IgG) | 0.30 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (MN - RSV/A) | 0.27 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (Anti-F IgG) | 0.33 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (MN - RSV/B) | 0.34 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (Anti-F IgG) | 0.32 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (Anti-F IgG) | 0.35 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 14 (PCA) | 0.76 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (MN - RSV/A) | 0.17 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 35 (PCA) | 0.58 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (MN - RSV/B) | 0.05 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (PCA) | 0.49 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (MN - RSV/A) | 0.10 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 90 (PCA) | 0.46 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 60 (MN - RSV/B) | 0.22 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 112/120 (PCA) | 0.51 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (MN - RSV/A) | 0.05 Fold Ratio |
| Formulated Buffer (Placebo Control) | Infant: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMR | Day 180 (PCA) | 0.50 Fold Ratio |
Secondary
Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life
Number of infants with AEs and SAEs (with special attention to congenital anomalies; respiratory failure other than RSV-associated hospitalization; neonatal death; infant death; sudden infant death syndrome; asphyxia; neonatal or hypoxic-ischemic encephalopathy; or other adverse events or complications of adverse events that necessitate hospitalization) during the neonatal period and through the first year of life.
Time frame: Delivery to 364 days after delivery
Population: The analysis population includes all infants born live to maternal subjects who received any test article and was analyzed as randomized unless conclusive documentation existed to confirm the mis-dosing of their respective mother and the identity of the treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Any AEs | 2468 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Overall SAEs (Including AESIs) | 1337 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Pre-Specified AESIs | 275 participants |
| Formulated Buffer (Placebo Control) | Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Any AEs | 1295 participants |
| Formulated Buffer (Placebo Control) | Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Overall SAEs (Including AESIs) | 724 participants |
| Formulated Buffer (Placebo Control) | Infant: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Neonatal Period and Through the First Year of Life | Pre-Specified AESIs | 151 participants |
Secondary
Infants: Mean APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Score of Participants at Birth
The APGAR test measures the infant's Appearance, Pulse, Grimace, Activity, and Respiration. Any score of 7 or above is considered a good APGAR score. The maximum APGAR score is 10 and the minimum score is 1.
Time frame: At Delivery
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Mean APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Score of Participants at Birth | 1 minute | 8.4 units on a scale | Standard Deviation 1.08 |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Mean APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Score of Participants at Birth | 5 minute | 9.4 units on a scale | Standard Deviation 0.78 |
| Formulated Buffer (Placebo Control) | Infants: Mean APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Score of Participants at Birth | 1 minute | 8.4 units on a scale | Standard Deviation 1.17 |
| Formulated Buffer (Placebo Control) | Infants: Mean APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Score of Participants at Birth | 5 minute | 9.4 units on a scale | Standard Deviation 0.91 |
Secondary
Infants: Mean Frontal-occipital Head Circumference of Participants at Birth
Frontal-occipital Head Circumference measured in infant participants at delivery expressed as centimeters
Time frame: At Delivery
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Mean Frontal-occipital Head Circumference of Participants at Birth | 34.2 centimeters | Standard Deviation 2.08 |
| Formulated Buffer (Placebo Control) | Infants: Mean Frontal-occipital Head Circumference of Participants at Birth | 34.2 centimeters | Standard Deviation 1.77 |
Secondary
Infants: Mean Length of Participants at Birth
Length of Infant participants measured at delivery expressed in centimeters
Time frame: At Delivery
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Mean Length of Participants at Birth | 50.04 centimeters | Standard Deviation 2.921 |
| Formulated Buffer (Placebo Control) | Infants: Mean Length of Participants at Birth | 50.16 centimeters | Standard Deviation 3.144 |
Secondary
Infants: Mean Weight of Participants at Birth
Weight of infant participants measured at delivery expressed in kilograms.
Time frame: At Delivery
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Mean Weight of Participants at Birth | 3.21 kg | Standard Deviation 0.484 |
| Formulated Buffer (Placebo Control) | Infants: Mean Weight of Participants at Birth | 3.20 kg | Standard Deviation 0.505 |
Secondary
Infants: Number of Participants With Developmental Delay
Number of infants with developmental delay (a term used to describe a delay in a child's development.), as measured by the outcome of testing at 1 year, in infants of RSV F vaccinees as compared to placebo.
Time frame: Day 364 after delivery
Population: The analysis population includes all infants born live to maternal subjects who received any test article and was analyzed as randomized unless conclusive documentation existed to confirm the mis-dosing of their respective mother and the identity of the treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Developmental Delay | On schedule for communication | 2670 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Developmental Delay | With any 12 months ASQ data | 2707 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Developmental Delay | On schedule for Gross Motor | 2535 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Developmental Delay | On schedule for Fine Motor | 2535 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Developmental Delay | On schedule for Problem Solving | 2546 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Developmental Delay | On Schedule for Personal-Social | 2559 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Developmental Delay | On schedule for Problem Solving | 1325 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Developmental Delay | On schedule for Fine Motor | 1318 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Developmental Delay | With any 12 months ASQ data | 1395 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Developmental Delay | On schedule for communication | 1387 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Developmental Delay | On Schedule for Personal-Social | 1317 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Developmental Delay | On schedule for Gross Motor | 1318 participants |
Secondary
Infants: Number of Participants With Potential Developmental Delay
Number of infants with potential developmental delay (a term used to describe a delay in a child's development), as measured by the outcome of testing with the Ages and Stages Questionnaire-3 at 6 months and at 1 year, in infants of RSV F vaccinees as compared to placebo.
Time frame: Day 180 after delivery
Population: The analysis population includes all infants born live to maternal subjects who received any test article and was analyzed as randomized unless conclusive documentation existed to confirm the mis-dosing of their respective mother and the identity of the treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Potential Developmental Delay | On schedule for Fine Motor | 2603 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Potential Developmental Delay | On schedule for Gross Motor | 2588 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Potential Developmental Delay | On schedule for Problem Solving | 2648 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Potential Developmental Delay | On schedule for communication | 2773 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Potential Developmental Delay | On Schedule for Personal-Social | 2481 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With Potential Developmental Delay | With any 6 months ASQ data | 2835 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Potential Developmental Delay | On Schedule for Personal-Social | 1280 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Potential Developmental Delay | With any 6 months ASQ data | 1460 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Potential Developmental Delay | On schedule for Gross Motor | 1298 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Potential Developmental Delay | On schedule for Fine Motor | 1364 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Potential Developmental Delay | On schedule for Problem Solving | 1381 participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With Potential Developmental Delay | On schedule for communication | 1424 participants |
Secondary
Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life
The number of infants with RSV LRTI with EITHER severe hypoxemia (SpO2 \< 92% at sea level or \< 87% at altitudes \> 1800 meters) OR the documented use of oxygen by high flow nasal cannula OR CPAP OR BiPAP OR Bubble CPAP OR bag-mask ventilation OR intubation with subsequent mechanical (or manual) ventilation OR ECMO from delivery through 90, 120, 150, and 180 days of life.
Time frame: Delivery to 180 days after delivery
Population: Analysis population includes infant participants who were ≥ 37 weeks GA at birth, and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery, and had not received prophylactic treatment with palivizumab between birth and Day 180 after delivery, and had at least 1 documented post-partum contact during which active and/or passive surveillance activities for RSV-suspect illness could occur.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 180 | 19 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 150 | 17 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 120 | 16 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 90 | 14 Participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 180 | 17 Participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 90 | 14 Participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 120 | 16 Participants |
| Formulated Buffer (Placebo Control) | Infants: Number of Participants With RSV LRTI With Severe Hypoxemia (Sp02 <92% at Sea Level or <87% at Altitudes >1800 Meters) or Documented Use of Oxygen by High Flow Nasal Cannula or Other Advanced Respiratory Support Through 90 Days of Life | Day 150 | 17 Participants |
Secondary
Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Infant Participants from Delivery until Day 180
Time frame: Delivery to Day 180
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (PCA) | 5.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (Anti-F IgG) | 6.5 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 20.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 14.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (MN - RSV/A) | 19.5 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (PCA) | 96.8 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (MN - RSV/A) | 17.4 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (Anti-F IgG) | 94.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (MN - RSV/A) | 13.8 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (PCA) | 95.4 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (MN - RSV/A) | 8.6 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (Anti-F IgG) | 95.9 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (MN - RSV/A) | 3.5 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (PCA) | 95.6 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 11.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (Anti-F IgG) | 77.0 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 54.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (PCA) | 92.0 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (MN - RSV/B) | 27.3 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (Anti-F IgG) | 95.9 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (MN - RSV/B) | 5.0 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (PCA) | 73.1 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (MN - RSV/B) | 40.0 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (Anti-F IgG) | 36.4 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (MN - RSV/B) | 5.3 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (PCA) | 29.7 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (MN - RSV/B) | 4.5 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (Anti-F IgG) | 94.1 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (MN - RSV/B) | 4.3 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (Anti-F IgG) | 5.0 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (Anti-F IgG) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (Anti-F IgG) | 4.8 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (Anti-F IgG) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (Anti-F IgG) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (Anti-F IgG) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (Anti-F IgG) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (PCA) | 4.6 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (PCA) | 4.7 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (PCA) | 4.4 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (PCA) | 4.4 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (PCA) | 4.7 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (PCA) | 4.7 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (PCA) | 4.1 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 3.1 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (MN - RSV/A) | 3.6 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (MN - RSV/A) | 4.8 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (MN - RSV/A) | 4.8 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (MN - RSV/A) | 5.0 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 180 (MN - RSV/A) | 4.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 4.3 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 4.5 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 35 (MN - RSV/B) | 4.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 60 (MN - RSV/B) | 4.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 90 (MN - RSV/B) | 4.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 112/120 (MN - RSV/B) | 3.7 percentage of participants |
| Formulated Buffer (Placebo Control) | Infants: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 5.0 percentage of participants |
Secondary
Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery
Percentages of infants with RSV LRTI with hospitalization from delivery through 90, 120, 150, and 180 days of life.
Time frame: Delivery to 180 days after delivery
Population: The analysis population includes infant participants who were ≥ 37 weeks GA at birth and born to maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery, and had not received prophylactic treatment with palivizumab between birth and Day 180 after delivery, and had at least 1 documented post-partum contact during which active and/or passive surveillance activities for RSV-suspect illness could occur.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 90 | 57 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 120 | 64 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 150 | 67 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 180 | 68 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 180 | 59 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 90 | 53 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 150 | 57 Participants |
| Formulated Buffer (Placebo Control) | Infants: Percentages of Participants With RSV LRTI With Hospitalization From Delivery | Day 120 | 56 Participants |
Secondary
Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL)
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG) among Maternal Participants from Screening until Delivery
Time frame: Pre-dose to Delivery +180 days
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Pre-Dose | 568 EU (ELISA units/mL) |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Day 14 | 10568 EU (ELISA units/mL) |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Delivery | 8164 EU (ELISA units/mL) |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Pre-Dose | 569 EU (ELISA units/mL) |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Day 14 | 563 EU (ELISA units/mL) |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of Anti-RSV F IgG and Placebo Expressed as GMEU (Geometric Mean ELISA Units/mL) | Delivery | 525 EU (ELISA units/mL) |
Secondary
Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration)
Immunogenicity of RSV F Vaccine and Placebo (Palivizumab-competitive antibodies (PCA)) among Maternal Participants from Screening until Delivery
Time frame: Pre-dose to Delivery +180 days
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Pre-Dose | 13 µg/mL |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Day 14 | 162 µg/mL |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Delivery | 130 µg/mL |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Pre-Dose | 13 µg/mL |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Day 14 | 13 µg/mL |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMC (Geometric Mean Concentration) | Delivery | 12 µg/mL |
Secondary
Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery
Time frame: Day 14 to Delivery
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (Anti F-IgG) | 18.59 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (MN - RSV/A) | 2.35 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (PCA) | 12.38 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (MN - RSV/A) | 2.20 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (MN - RSV/B) | 3.00 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (Anti F-IgG) | 14.37 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (MN - RSV/B) | 2.15 Fold Ratio |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (PCA) | 9.94 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (MN - RSV/B) | 0.88 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (Anti F-IgG) | 0.99 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (Anti F-IgG) | 0.92 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (PCA) | 0.94 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (PCA) | 0.92 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (MN - RSV/A) | 0.98 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Day 14 (MN - RSV/B) | 0.96 Fold Ratio |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMFR | Delivery (MN - RSV/A) | 0.89 Fold Ratio |
Secondary
Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers)
Immunogenicity of RSV F Vaccine and Placebo (RSV/A microneutralization titers expressed as GMT) among Maternal Participants from Screening until Delivery
Time frame: Pre-dose to Delivery +180 days
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.~Per-Protocol Immunogenicity Maternal (PP-IMM-M) participant population is analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Pre-Dose | 714 titers |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Day 14 | 1622 titers |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Delivery | 1569 titers |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Pre-Dose | 741 titers |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Day 14 | 654 titers |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMT (Geometric Mean Titers) | Delivery | 663 titers |
Secondary
Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs
Immunogenicity of RSV F Vaccine and Placebo (RSV/B microneutralization titers expressed as GMT) among Maternal Participants from Screening until Delivery
Time frame: Pre-dose to Delivery +180 days
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.~Per-Protocol Immunogenicity Maternal (PP-IMM-M) participant population is analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Pre-Dose | 563 titers |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Day 14 | 2419 titers |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Delivery | 1213 titers |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Pre-Dose | 605 titers |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Day 14 | 845 titers |
| Formulated Buffer (Placebo Control) | Maternal: Immunogenicity of RSV F Vaccine and Placebo Expressed as GMTs | Delivery | 534 titers |
Secondary
Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery
Number of maternal subjects that had either Caesarean, vaginal, or instrument-assisted vaginal modes of delivery.
Time frame: Delivery
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Vaginal (spontaneous) | 2110 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | No Data | 22 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Forceps or vacuum assisted delivery | 91 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Planned (repeat) Caesarean delivery | 225 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Planned (primary) Caesarean delivery | 111 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Caesarean delivery after failed attempt at vaginal delivery | 123 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Emergency Caesarean delivery | 347 count of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Unknown | 16 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Unknown | 10 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Vaginal (spontaneous) | 1076 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Planned (primary) Caesarean delivery | 47 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | No Data | 16 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Emergency Caesarean delivery | 178 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Forceps or vacuum assisted delivery | 56 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Caesarean delivery after failed attempt at vaginal delivery | 66 count of participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Caesarean, Vaginal, or Instrument Assisted Vaginal Modes of Delivery | Planned (repeat) Caesarean delivery | 132 count of participants |
Secondary
Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery
Number of maternal participants with post-immunization onset of specific complications of third-trimester pregnancy and delivery including Pregnancy complications, Labor and delivery complications.
Time frame: Day 0 to Delivery
Population: maternal safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | No | 2528 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | Yes | 488 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | No Data | 13 Participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | Subjects without delivery data | 16 Participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | Subjects without delivery data | 10 Participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | No | 1295 Participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | No Data | 8 Participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Post-immunization Onset of Specific Complications of Third-trimester Pregnancy and Delivery | Yes | 268 Participants |
Secondary
Maternal: Number of Participants With Solicited Injection Site and Systemic Reactogenicity
A number of maternal participants with solicited injection site and systemic reactogenicity within seven days of vaccination.
Time frame: Day 0 to Day 7
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Solicited Injection Site and Systemic Reactogenicity | Total Solicited Local AE's | 1240 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Solicited Injection Site and Systemic Reactogenicity | Total Solicited Systematic AE's | 1255 participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Solicited Injection Site and Systemic Reactogenicity | Total Solicited Systematic AE's | 611 participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Solicited Injection Site and Systemic Reactogenicity | Total Solicited Local AE's | 157 participants |
Secondary
Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs)
Number of maternal participants with unsolicited (local and systemic) adverse events (AEs), unscheduled medically-attended adverse events (MAEs), significant new medical conditions (SNMCs), and serious adverse events (SAEs) through delivery and six (6) months thereafter.
Time frame: Delivery to 180 days after delivery
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | Unsolicited AEs | 2004 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | MAEs | 1534 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | SNMCs | 65 participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | SAEs | 906 participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | SAEs | 455 participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | Unsolicited AEs | 1022 participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | MAEs | 802 participants |
| Formulated Buffer (Placebo Control) | Maternal: Number of Participants With Unsolicited Adverse Events, Medically-attended Adverse Events (MAEs), Significant New Medical Conditions (SNMCs) and Serious Adverse Events (SAEs) | SNMCs | 38 participants |
Secondary
Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery
Time frame: Day 14 to Delivery
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (Anti F-IgG) | 98.3 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery(Anti F-IgG) | 98.1 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (PCA) | 98.0 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (PCA) | 97.7 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 69.1 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 59.0 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 70.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 53.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 4.3 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (Anti F-IgG) | 1.1 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 4.3 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery(Anti F-IgG) | 2.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 8.7 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (PCA) | 0.5 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 5.5 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (2 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (PCA) | 2.1 percentage of participants |
Secondary
Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery
Time frame: Day 14 to Delivery
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (Anti F-IgG) | 91.8 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 19.1 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (PCA) | 88.1 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 18.6 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 35.1 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery(Anti F-IgG) | 89.7 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 17.6 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (PCA) | 84.8 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 1.0 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (Anti F-IgG) | 0.4 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery(Anti F-IgG) | 0.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (PCA) | 0.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (PCA) | 0.6 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 0 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 1.1 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants Who Seroconverted (4 Fold Increase) as Determined by Immunogenicity of RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 1.2 percentage of participants |
Secondary
Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo
Immunogenicity of RSV F Vaccine and Placebo (Anti-F IgG, PCA, and RSV Types A and B - MN assays) among Maternal Participants from Day 14 until Delivery
Time frame: Day 14 to Delivery
Population: The analysis population includes maternal participants who received a study injection as randomized and ≥ 2 weeks prior to delivery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (Anti F-IgG) | 98.3 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 57.2 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (Anti F-IgG) | 97.5 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (PCA) | 99.4 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (PCA) | 97.9 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 71.3 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 55.6 percentage of participants |
| Adjuvanted RSV F Vaccine (120 µg RSVF Protein Adsorbed to a 0.4 mg Dose of Aluminum) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 70.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/B) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (Anti F-IgG) | 5.0 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/B) | 8.7 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (PCA) | 4.2 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (MN - RSV/A) | 4.9 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Delivery (Anti F-IgG) | 5.0 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (MN - RSV/A) | 4.3 percentage of participants |
| Formulated Buffer (Placebo Control) | Maternal: Percentage of Participants With a Seroresponse to RSV F Vaccine and Placebo | Day 14 (PCA) | 5.0 percentage of participants |