Respiratory Tract Infection
Conditions
Keywords
Respiratory tract infection, Respiratory Syncytial Virus, RSV, Vaccine
Brief summary
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.
Detailed description
This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.
Interventions
BIOLOGICALRSV vaccine
RSV vaccine
BIOLOGICALPlacebo
Normal saline solution for injection (0.9% sodium chloride injection)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but the participant and all other study personnel, including the principal investigator, will be blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
- Maternal participants: * Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Receiving prenatal standard of care. * Had an ultrasound performed at \>=18 weeks of pregnancy. * Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal. * Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study. * Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit. * Body mass index of \</=40 kg/m2 at the time of the screening visit. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol. * Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study. Inclusion Criteria - Infant Participants: * Evidence of a signed and dated ICD signed by the parent(s). * Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
- Maternal Participants: * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the investigational product or any related vaccine. * History of latex allergy. * History of any severe allergic reaction. * Participants with known or suspected immunodeficiency. * Current pregnancy resulting from in vitro fertilization or other assisted reproductive technology. * A prior history of or known current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in and completion of the study. * Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response. * Participant with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1). * Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. * Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or planned receipt of such treatment or agents during study participation. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before investigational product administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. * Current alcohol abuse or illicit drug use. * Receipt of blood or plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time. * Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation. * Laboratory test results at the screening visit outside the normal reference value for pregnant women according to their trimester in pregnancy. * Participants who are breastfeeding at the time of the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Within 7 days after vaccination | Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. |
| Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Within 7 days after vaccination | Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\>=38.0 to 38.4 degrees \[deg\] Celsius \[C\]), grade 2: moderate (\>38.4 to 38.9 deg C), grade 3: severe (\>38.9 to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. |
| Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination | Within 1 month after vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. |
| Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | From day of vaccination (Day 1) up to 12 months post-delivery | MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement. |
| Percentage of Infant Participants With Specific Birth Complications | At birth | Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure. |
| Percentage of Infant Participants With Any AE Within 1 Month of Age | Within 1 month after birth | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. |
| Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | Within 12 months after birth | MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. |
| Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Within 12 months after birth | AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | Before vaccination, 2 weeks and 1 month after vaccination and at delivery | GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis. |
| Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | 2 weeks and 1 month after vaccination, at delivery | GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only. |
| Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | At birth and at 1, 2, 4, 6 months after birth | GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis. |
Countries
Argentina, Chile, New Zealand, South Africa, United States
Participant flow
Recruitment details
Pregnant maternal participants between 18 to 49 years of age and infants who were born to these maternal participants were enrolled in this study.
Pre-assignment details
778 maternal participants signed the informed consent form (ICF). 197 participants were screen failures who did not meet criteria and were not enrolled. 581 maternal participants and 572 infants born to maternal participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Maternal Participants: RSVpreF 120 mcg Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery. | 115 |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery. | 117 |
| Maternal Participants: RSVpreF 240 mcg Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery. | 116 |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery. | 114 |
| Maternal Participants: Placebo Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery. | 117 |
| Infant Participants: RSVpreF 120 mcg Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 114 |
| Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 117 |
| Infant Participants: RSVpreF 240 mcg Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 113 |
| Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 112 |
| Infant Participants: Placebo Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 116 |
| Total | 1,151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 7 | 6 | 10 | 13 | 7 | 7 | 5 | 9 | 12 |
| Overall Study | No Longer Meets Eligibility Criteria | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Other | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Parent/Guardian | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 2 | 2 | 3 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Maternal Participants: RSVpreF 120 mcg | Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Maternal Participants: RSVpreF 240 mcg | Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Maternal Participants: Placebo | Infant Participants: RSVpreF 120 mcg | Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Infant Participants: RSVpreF 240 mcg | Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Infant Participants: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Greater than or equal to (>=)18 and <= 49 years | 579 Participants | 115 Participants | 117 Participants | 116 Participants | 114 Participants | 117 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than or equal to(<=) 18 years | 572 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 114 Participants | 117 Participants | 113 Participants | 112 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 323 Participants | 32 Participants | 34 Participants | 28 Participants | 33 Participants | 33 Participants | 33 Participants | 37 Participants | 28 Participants | 32 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 822 Participants | 83 Participants | 83 Participants | 87 Participants | 81 Participants | 84 Participants | 81 Participants | 79 Participants | 84 Participants | 79 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 237 Participants | 25 Participants | 25 Participants | 26 Participants | 24 Participants | 19 Participants | 25 Participants | 24 Participants | 27 Participants | 23 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 4 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 859 Participants | 85 Participants | 86 Participants | 88 Participants | 86 Participants | 94 Participants | 79 Participants | 86 Participants | 82 Participants | 84 Participants | 89 Participants |
| Sex: Female, Male Female | 865 Participants | 115 Participants | 117 Participants | 116 Participants | 114 Participants | 117 Participants | 62 Participants | 58 Participants | 58 Participants | 55 Participants | 53 Participants |
| Sex: Female, Male Male | 286 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 52 Participants | 59 Participants | 55 Participants | 57 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 117 | 0 / 116 | 0 / 114 | 0 / 117 | 0 / 114 | 0 / 117 | 0 / 113 | 0 / 112 | 0 / 116 |
| other Total, other adverse events | 87 / 115 | 108 / 117 | 96 / 116 | 103 / 114 | 89 / 117 | 66 / 114 | 59 / 117 | 67 / 113 | 66 / 112 | 71 / 116 |
| serious Total, serious adverse events | 7 / 115 | 15 / 117 | 15 / 116 | 19 / 114 | 14 / 117 | 41 / 114 | 39 / 117 | 35 / 113 | 44 / 112 | 38 / 116 |
Outcome results
Primary
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.
Time frame: Within 12 months after birth
Population: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Congenital Anomalies | 9.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Developmental Delay | 0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Congenital Anomalies | 4.3 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Developmental Delay | 0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Congenital Anomalies | 1.8 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Developmental Delay | 0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Developmental Delay | 0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Congenital Anomalies | 1.8 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Congenital Anomalies | 6.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay | Developmental Delay | 0 Percentage of participants |
Primary
Percentage of Infant Participants With Any AE Within 1 Month of Age
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Time frame: Within 1 month after birth
Population: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Infant Participants With Any AE Within 1 Month of Age | 50.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Infant Participants With Any AE Within 1 Month of Age | 47.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Infant Participants With Any AE Within 1 Month of Age | 46.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Infant Participants With Any AE Within 1 Month of Age | 49.1 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Infant Participants With Any AE Within 1 Month of Age | 50.9 Percentage of participants |
Primary
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Time frame: Within 12 months after birth
Population: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | MAE | 22.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | SAE | 36.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | MAE | 29.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | SAE | 33.3 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | MAE | 30.1 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | SAE | 31.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | SAE | 39.3 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | MAE | 38.4 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | MAE | 31.9 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age | SAE | 32.8 Percentage of participants |
Primary
Percentage of Infant Participants With Specific Birth Complications
Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.
Time frame: At birth
Population: Infant safety population included all infant participants who were born to vaccinated maternal participants and were analyzed according to the investigational product their mothers received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Infant Participants With Specific Birth Complications | 7.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Infant Participants With Specific Birth Complications | 10.3 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Infant Participants With Specific Birth Complications | 8.8 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Infant Participants With Specific Birth Complications | 8.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Infant Participants With Specific Birth Complications | 9.5 Percentage of participants |
Primary
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Time frame: Within 1 month after vaccination
Population: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 22.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 23.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 30.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 22.8 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination | 24.8 Percentage of participants |
Primary
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
Time frame: Within 7 days after vaccination
Population: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Mild | 22.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Mild | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Moderate | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Moderate | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Moderate | 6.1 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Mild | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Moderate | 1.7 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Mild | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Mild | 53.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Mild | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Moderate | 15.7 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Severe | 1.7 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Moderate | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Moderate | 5.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Mild | 28.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Mild | 5.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Moderate | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Mild | 4.3 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Moderate | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Moderate | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Moderate | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Moderate | 13.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Mild | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Mild | 47.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Mild | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Moderate | 0.9 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Mild | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Redness: Mild | 0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Pain at injection site: Mild | 12.8 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination | Swelling: Moderate | 0.0 Percentage of participants |
Primary
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\>=38.0 to 38.4 degrees \[deg\] Celsius \[C\]), grade 2: moderate (\>38.4 to 38.9 deg C), grade 3: severe (\>38.9 to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.
Time frame: Within 7 days after vaccination
Population: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Moderate | 24.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Mild | 14.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Mild | 9.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 4 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Mild | 11.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Mild | 18.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Mild | 22.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Moderate | 16.7 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Moderate | 9.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Moderate | 10.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 2 | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Moderate | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Moderate | 11.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Mild | 4.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Moderate | 5.3 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 3 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 1 | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Mild | 14.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Mild | 17.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 3 | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Moderate | 14.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Moderate | 8.7 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Mild | 28.7 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Mild | 10.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 4 | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Mild | 27.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Moderate | 5.2 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Moderate | 17.4 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 2 | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Mild | 7.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Severe | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 1 | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Mild | 19.1 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Moderate | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Moderate | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Moderate | 16.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Mild | 7.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Severe | 1.7 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 1 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 2 | 1.7 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 3 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 4 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Mild | 23.3 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Moderate | 19.8 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Severe | 2.6 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Mild | 25.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Moderate | 12.1 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Mild | 16.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Moderate | 8.6 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Mild | 21.6 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Moderate | 12.1 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Mild | 11.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Moderate | 9.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Mild | 5.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Moderate | 1.7 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Mild | 9.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Moderate | 1.7 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Severe | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Mild | 25.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Moderate | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Moderate | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Moderate | 10.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 2 | 0.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 4 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 1 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Severe | 1.8 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Moderate | 3.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 3 | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Mild | 7.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Mild | 7.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Moderate | 23.7 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Mild | 21.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Severe | 0.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Moderate | 4.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Mild | 4.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Mild | 18.4 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Moderate | 14.0 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Mild | 14.9 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Moderate | 5.1 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Severe | 1.7 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Moderate | 9.4 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Mild | 5.1 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Headache: Mild | 14.5 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Moderate | 4.3 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Severe | 1.7 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Joint pain: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Moderate | 20.5 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Moderate | 1.7 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Mild | 6.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fatigue: Mild | 24.8 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 1 | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Moderate | 1.7 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 4 | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Vomiting: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 3 | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Severe | 0.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Moderate | 6.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Diarrhea: Mild | 12.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Muscle pain: Mild | 6.8 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Nausea: Mild | 16.2 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination | Fever: Grade 2 | 0.9 Percentage of participants |
Primary
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.
Time frame: From day of vaccination (Day 1) up to 12 months post-delivery
Population: Maternal safety population included all randomized maternal participants who received investigational product and were analyzed according to the investigational product they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | SAE | 6.1 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | Obstetric complications | 23.5 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | MAE | 20.0 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | MAE | 18.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | SAE | 12.8 Percentage of participants |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | Obstetric complications | 28.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | MAE | 15.5 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | SAE | 12.9 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | Obstetric complications | 30.2 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | SAE | 16.7 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | Obstetric complications | 33.3 Percentage of participants |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | MAE | 21.1 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | MAE | 17.1 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | SAE | 12.0 Percentage of participants |
| Maternal Participants: Placebo | Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications | Obstetric complications | 32.5 Percentage of participants |
Secondary
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.
Time frame: 2 weeks and 1 month after vaccination, at delivery
Population: Maternal evaluable immunogenicity population: eligible maternal participants who received randomized vaccine, had blood collection within protocol-specified time points, had at least 1 valid and determinate assay result after vaccination and had no other major protocol deviations. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 1 Month after vaccination | 14.9 Fold rise |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: At delivery | 9.2 Fold rise |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: At delivery | 8.3 Fold rise |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 1 Month after vaccination | 19.2 Fold rise |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 2 Weeks after vaccination | 21.8 Fold rise |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 2 Weeks after vaccination | 19.8 Fold rise |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: At delivery | 10.9 Fold rise |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: At delivery | 11.2 Fold rise |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 1 Month after vaccination | 19.6 Fold rise |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 2 Weeks after vaccination | 20.4 Fold rise |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 2 Weeks after vaccination | 21.0 Fold rise |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 1 Month after vaccination | 22.0 Fold rise |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 2 Weeks after vaccination | 26.4 Fold rise |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: At delivery | 8.6 Fold rise |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 2 Weeks after vaccination | 23.3 Fold rise |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 1 Month after vaccination | 17.7 Fold rise |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: At delivery | 9.5 Fold rise |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 1 Month after vaccination | 15.9 Fold rise |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 2 Weeks after vaccination | 30.4 Fold rise |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 2 Weeks after vaccination | 25.3 Fold rise |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: At delivery | 10.6 Fold rise |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 1 Month after vaccination | 20.9 Fold rise |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: At delivery | 10.7 Fold rise |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 1 Month after vaccination | 17.8 Fold rise |
| Maternal Participants: Placebo | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: At delivery | 0.7 Fold rise |
| Maternal Participants: Placebo | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 2 Weeks after vaccination | 1.1 Fold rise |
| Maternal Participants: Placebo | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: 1 Month after vaccination | 1.0 Fold rise |
| Maternal Participants: Placebo | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | A 50%: At delivery | 0.8 Fold rise |
| Maternal Participants: Placebo | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 2 Weeks after vaccination | 1.0 Fold rise |
| Maternal Participants: Placebo | Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants | B 50%: 1 Month after vaccination | 1.0 Fold rise |
Secondary
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Time frame: At birth and at 1, 2, 4, 6 months after birth
Population: Infant evaluable immunogenicity population: eligible infant participants born to maternal participants who received randomized vaccine and had no protocol deviation before delivery, had blood collection within protocol-specified time point at birth, had at least 1 valid, determinate assay result at birth and had no other major protocol deviations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 6 Months after birth | 1609 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: At birth | 30195 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 4 Months after birth | 2673 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: At birth | 22904 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 1 Month after birth | 17418 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 1 Month after birth | 13532 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 4 Months after birth | 3168 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 6 Months after birth | 1529 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 2 Months after birth | 13411 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 2 Months after birth | 11127 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 1 Month after birth | 18708 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 6 Months after birth | 1195 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 6 Months after birth | 1124 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 2 Months after birth | 8341 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 4 Months after birth | 3919 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: At birth | 28437 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 1 Month after birth | 14667 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 4 Months after birth | 4075 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: At birth | 23281 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 2 Months after birth | 7455 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: At birth | 20530 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 2 Months after birth | 6943 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 1 Month after birth | 12685 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 6 Months after birth | 930 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 1 Month after birth | 17911 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 2 Months after birth | 7251 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 4 Months after birth | 2621 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 4 Months after birth | 2148 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 6 Months after birth | 956 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: At birth | 25112 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 1 Month after birth | 20353 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: At birth | 32967 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 2 Months after birth | 12359 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 4 Months after birth | 4135 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 6 Months after birth | 1381 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 6 Months after birth | 1048 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: At birth | 24290 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 1 Month after birth | 15383 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 2 Months after birth | 10552 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 4 Months after birth | 2936 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: At birth | 2029 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 2 Months after birth | 702 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 6 Months after birth | 233 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 6 Months after birth | 221 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 4 Months after birth | 458 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 2 Months after birth | 700 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 4 Months after birth | 478 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | B 50%: 1 Month after birth | 1586 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: 1 Month after birth | 1514 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants | A 50%: At birth | 2150 Titer |
Comparison: A 50%: At birth95% CI: [8.1, 14.1]
Comparison: A 50%: 1 Month after birth95% CI: [5.5, 14.5]
Comparison: A 50%: 2 Months after birth95% CI: [10.7, 23.4]
Comparison: A 50%: 4 Months after birth95% CI: [3.5, 9]
Comparison: A 50%: 6 Months after birth95% CI: [4.5, 9.6]
Comparison: B 50%: At birth95% CI: [11.1, 19.9]
Comparison: B 50%: 1 Month after birth95% CI: [6.5, 18.6]
Comparison: B 50%: 2 Months after birth95% CI: [13.1, 28]
Comparison: B 50%: 4 Months after birth95% CI: [4.2, 11.4]
Comparison: B 50%: 6 Months after birth95% CI: [4.5, 11.8]
Comparison: A 50%: At birth95% CI: [8.3, 14.2]
Comparison: A 50%: 1 Month after birth95% CI: [6.5, 14.5]
Comparison: A 50%: 2 Months after birth95% CI: [7.1, 15.9]
Comparison: A 50%: 4 Months after birth95% CI: [5.2, 12.9]
Comparison: A 50%: 6 Months after birth95% CI: [3.1, 7.5]
Comparison: B 50%: At birth95% CI: [10.5, 18.7]
Comparison: B 50%: 1 Month after birth95% CI: [7.4, 18.7]
Comparison: B 50%: 2 Months after birth95% CI: [7.7, 18.3]
Comparison: B 50%: 4 Months after birth95% CI: [5.5, 14.5]
Comparison: B 50%: 6 Months after birth95% CI: [3.3, 8.8]
Comparison: A 50%: At birth95% CI: [7.4, 12.3]
Comparison: A 50%: 1 Month after birth95% CI: [5.7, 12.4]
Comparison: A 50%: 2 Months after birth95% CI: [6.4, 15.4]
Comparison: A 50%: 4 Months after birth95% CI: [2.9, 6.8]
Comparison: A 50%: 6 Months after birth95% CI: [2.5, 6.3]
Comparison: B 50%: At birth95% CI: [9.2, 16.6]
Comparison: B 50%: 1 Month after birth95% CI: [7.1, 17.9]
Comparison: B 50%: 2 Months after birth95% CI: [7, 15.2]
Comparison: B 50%: 4 Months after birth95% CI: [3.7, 9]
Comparison: B 50%: 6 Months after birth95% CI: [2.7, 7]
Comparison: A 50%: At birth95% CI: [8.6, 14.9]
Comparison: A 50%: 1 Month after birth95% CI: [7.4, 14]
Comparison: A 50%: 2 Months after birth95% CI: [10.2, 22.1]
Comparison: A 50%: 4 Months after birth95% CI: [3.9, 9.6]
Comparison: A 50%: 6 Months after birth95% CI: [2.9, 6.9]
Comparison: B 50%: At birth95% CI: [12.5, 21.2]
Comparison: B 50%: 1 Month after birth95% CI: [8.6, 19.1]
Comparison: B 50%: 2 Months after birth95% CI: [11.9, 26.2]
Comparison: B 50%: 4 Months after birth95% CI: [5.7, 14.4]
Comparison: B 50%: 6 Months after birth95% CI: [3.9, 9.9]
Secondary
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Time frame: Before vaccination, 2 weeks and 1 month after vaccination and at delivery
Population: Maternal evaluable immunogenicity population: eligible maternal participants who received randomized vaccine, had blood collection within protocol-specified time points, had at least 1 valid and determinate assay result after vaccination and had no other major protocol deviations. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: At delivery | 12914 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: Before vaccination | 1574 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: Before vaccination | 1756 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 1 Month after vaccination | 24149 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 1 Month after vaccination | 34397 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: At delivery | 16157 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 2 Weeks after vaccination | 31871 Titer |
| Maternal Participants: RSVpreF 120 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 2 Weeks after vaccination | 39152 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 1 Month after vaccination | 31007 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 2 Weeks after vaccination | 36382 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 2 Weeks after vaccination | 31644 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: Before vaccination | 1577 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: At delivery | 19952 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 1 Month after vaccination | 37931 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: At delivery | 17259 Titer |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: Before vaccination | 1756 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: Before vaccination | 1647 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: At delivery | 12231 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: Before vaccination | 1432 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 1 Month after vaccination | 30339 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: At delivery | 16011 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 2 Weeks after vaccination | 43030 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 1 Month after vaccination | 23692 Titer |
| Maternal Participants: RSVpreF 240 mcg | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 2 Weeks after vaccination | 33532 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 1 Month after vaccination | 28106 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: Before vaccination | 1521 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 2 Weeks after vaccination | 39874 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: At delivery | 15814 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: Before vaccination | 1792 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 2 Weeks after vaccination | 55967 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 1 Month after vaccination | 39055 Titer |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: At delivery | 19130 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: At delivery | 1150 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: At delivery | 1184 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 1 Month after vaccination | 1686 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 1 Month after vaccination | 1549 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: 2 Weeks after vaccination | 1597 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | A 50%: Before vaccination | 1450 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: 2 Weeks after vaccination | 1615 Titer |
| Maternal Participants: Placebo | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants | B 50%: Before vaccination | 1652 Titer |
Comparison: B 50%: At delivery95% CI: [12, 21.7]
Comparison: A 50%: Before vaccination95% CI: [0.9, 1.3]
Comparison: A 50%: 2 Weeks after vaccination95% CI: [16.1, 24.7]
Comparison: A 50%: 1 Month after vaccination95% CI: [11.9, 20.4]
Comparison: A 50%: At delivery95% CI: [8.7, 14.5]
Comparison: B 50%: Before vaccination95% CI: [0.9, 1.3]
Comparison: B 50%: 2 Weeks after vaccination95% CI: [18.5, 31.7]
Comparison: B 50%: 1 Month after vaccination95% CI: [15.7, 26.6]
Comparison: B 50%: At delivery95% CI: [10.1, 18.4]
Comparison: A 50%: Before vaccination95% CI: [0.9, 1.3]
Comparison: A 50%: 2 Weeks after vaccination95% CI: [15.3, 25.7]
Comparison: A 50%: 1 Month after vaccination95% CI: [15.9, 25.1]
Comparison: A 50%: At delivery95% CI: [11.9, 18.9]
Comparison: B 50%: Before vaccination95% CI: [0.8, 1.3]
Comparison: B 50%: 2 Weeks after vaccination95% CI: [16.9, 30.1]
Comparison: B 50%: 1 Month after vaccination95% CI: [17.6, 28.7]
Comparison: B 50%: At delivery95% CI: [12.7, 22.3]
Comparison: A 50%: Before vaccination95% CI: [0.8, 1.2]
Comparison: A 50%: 2 Weeks after vaccination95% CI: [16.6, 26.5]
Comparison: A 50%: 1 Month after vaccination95% CI: [11.6, 20.1]
Comparison: A 50%: At delivery95% CI: [8.1, 14]
Comparison: B 50%: Before vaccination95% CI: [0.8, 1.3]
Comparison: B 50%: 2 Weeks after vaccination95% CI: [20.5, 34.6]
Comparison: B 50%: 1 Month after vaccination95% CI: [13.5, 24.1]
Comparison: B 50%: At delivery95% CI: [10.1, 18]
Comparison: A 50%: Before vaccination95% CI: [0.9, 1.3]
Comparison: A 50%: 2 Weeks after vaccination95% CI: [19.9, 31.3]
Comparison: A 50%: 1 Month after vaccination95% CI: [14.5, 22.8]
Comparison: A 50%: At delivery95% CI: [10.8, 17.5]
Comparison: B 50%: Before vaccination95% CI: [0.9, 1.4]
Comparison: B 50%: 2 Weeks after vaccination95% CI: [27, 44.4]
Comparison: B 50%: 1 Month after vaccination95% CI: [18.2, 29.6]