RSV
Conditions
Keywords
RSV, Vaccine
Brief summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.
Detailed description
This randomized, double-blinded, placebo-controlled Phase 3 study will examine the immune response and the safety and tolerability profiles across 3 manufactured lots of RSVpreF when administered as a single 120 µg dose to healthy adults to demonstrate lot equivalence in manufacturing of RSVpreF.
Interventions
BIOLOGICALRSVpreF (Group 1)
RSV vaccine (RSVpreF)
BIOLOGICALRSVpreF (Group 2)
RSV vaccine (RSVpreF)
BIOLOGICALRSVpreF (Group 3)
RSV vaccine (RSVpreF)
BIOLOGICALPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blinded, placebo controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or nonpregnant, nonbreastfeeding females between the ages of 18 and ≤49 years, inclusive, at Visit 1 (Day 1). 2. Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e diary for 7 days after study vaccination. 3. Healthy participants as determined by medical history, physical examination (if required), and the clinical judgment of the investigator to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable in the clinical judgment of the investigator may be included. 4. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
Exclusion criteria
1. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection. 2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine. 3. Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 3 months before receipt of study intervention. 4. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 5. Known infection with HIV, HCV, or HBV. 6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 7. Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment or planned receipt throughout the study. 8. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. 9. Receipt of monoclonal antibodies from 60 days before study intervention administration or planned receipt throughout the study. 10. Receipt of systemic treatment with known immunosuppressant medications within 60 days before study intervention administration or the use of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to study enrollment. Prednisone use of \<20 mg/day for \<14 days is permitted. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, ears) corticosteroids are permitted. 11. Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales. 12. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s). 13. Participation in other studies involving investigational drug(s) or investigational vaccines within 28 days prior to consent and/or during study participation. 14. Pregnant females; breastfeeding females; and women of child bearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study. 15. Men who are unwilling to comply with contraception methods as outlined in the protocol for the duration of the study. 16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | 1 month (27 to 42 days window) after vaccination on Day 1 | Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Within 7 days after vaccination on Day 1 | 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 activity, moderate: interfered with activity and severe: prevented daily activity. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Within 7 days after vaccination on Day 1 | Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was defined as temperature greater than or equal to (\>=)38.0 degrees Celsius (C) and categorized as mild (\>=38.0 to 38.4 degrees C), moderate (\>38.4 to 38.9 degrees C) and severe (\>38.9 to 40.0 degrees 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. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day of consent (Day 1) through study completion (approximately 1 Month) | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events excluding local reactions and systemic events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening ; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. |
Countries
United States
Participant flow
Pre-assignment details
A total of 1028 participants signed the informed consent form (ICF) and were enrolled. Out of which, 35 participants were not eligible for randomization and 993 participants were randomized into the study. Only 992 participants were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1. | 247 |
| Group 1: RSVpreF Lot 1 Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1. | 249 |
| Group 2: RSVpreF Lot 2 Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1. | 247 |
| Group 3: RSVpreF Lot 3 Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1. | 249 |
| Total | 992 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 | 5 | 2 |
| Overall Study | No longer met eligibility criteria | 1 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | Placebo | Group 1: RSVpreF Lot 1 | Group 2: RSVpreF Lot 2 | Group 3: RSVpreF Lot 3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 34.46 Years STANDARD_DEVIATION 8.73 | 34.16 Years STANDARD_DEVIATION 8.58 | 33.81 Years STANDARD_DEVIATION 9.02 | 33.90 Years STANDARD_DEVIATION 9.02 | 34.08 Years STANDARD_DEVIATION 8.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 60 Participants | 65 Participants | 68 Participants | 55 Participants | 248 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 185 Participants | 180 Participants | 174 Participants | 189 Participants | 728 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 5 Participants | 5 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 16 Participants | 7 Participants | 9 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 53 Participants | 53 Participants | 50 Participants | 204 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 4 Participants | 5 Participants | 1 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 2 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) White | 178 Participants | 169 Participants | 177 Participants | 179 Participants | 703 Participants |
| Sex: Female, Male Female | 140 Participants | 138 Participants | 158 Participants | 157 Participants | 593 Participants |
| Sex: Female, Male Male | 107 Participants | 111 Participants | 89 Participants | 92 Participants | 399 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 247 | 0 / 249 | 0 / 247 | 0 / 249 | 0 / 745 |
| other Total, other adverse events | 130 / 247 | 170 / 249 | 172 / 247 | 166 / 249 | 508 / 745 |
| serious Total, serious adverse events | 0 / 247 | 0 / 249 | 0 / 247 | 0 / 249 | 0 / 745 |
Outcome results
Primary
Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots
Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis.
Time frame: 1 month (27 to 42 days window) after vaccination on Day 1
Population: Evaluable immunogenicity population included all eligible participants who received vaccine to which they were randomized at visit 1, had a valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination and had no other major protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: RSVpreF Lot 1 | Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | RSV A | 25238.1 Titer |
| Group 1: RSVpreF Lot 1 | Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | RSV B | 21701.9 Titer |
| Group 2: RSVpreF Lot 2 | Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | RSV A | 25207.5 Titer |
| Group 2: RSVpreF Lot 2 | Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | RSV B | 20317.3 Titer |
| Group 3: RSVpreF Lot 3 | Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | RSV A | 24130.9 Titer |
| Group 3: RSVpreF Lot 3 | Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots | RSV B | 19238.1 Titer |
Comparison: RSV A95% CI: [0.858, 1.169]
Comparison: RSV A95% CI: [0.9, 1.215]
Comparison: RSV A95% CI: [0.886, 1.232]
Comparison: RSV B95% CI: [0.905, 1.261]
Comparison: RSV B95% CI: [0.953, 1.336]
Comparison: RSV B95% CI: [0.884, 1.262]
Primary
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events excluding local reactions and systemic events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening ; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Day of consent (Day 1) through study completion (approximately 1 Month)
Population: Safety population included all randomized participants who received study intervention. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 6.1 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 5.8 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Percentage of participants |
Primary
Percentage of Participants With Local Reactions 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 activity, moderate: interfered with activity and severe: prevented daily activity. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination on Day 1
Population: Safety population included all randomized participants who received study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at injection site: Mild | 10.5 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at injection site: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 0.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 0.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at injection site: Moderate | 0.8 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 0.4 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Severe | 0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at injection site: Mild | 31.5 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at injection site: Moderate | 5.4 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Mild | 4.4 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Moderate | 2.8 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Redness: Severe | 0.5 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Mild | 4.0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Swelling: Moderate | 3.8 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Pain at injection site: Severe | 0 Percentage of participants |
Primary
Percentage of Participants With Systemic Events 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 defined as temperature greater than or equal to (\>=)38.0 degrees Celsius (C) and categorized as mild (\>=38.0 to 38.4 degrees C), moderate (\>38.4 to 38.9 degrees C) and severe (\>38.9 to 40.0 degrees 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. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination on Day 1
Population: Safety population included all randomized participants who received study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 12.6 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle Pain: Mild | 7.7 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 0.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 0.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 19.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 1.2 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 18.2 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 10.1 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Mild | 4.5 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Moderate | 2.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 0.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 5.7 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 4.9 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0.4 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle Pain: Moderate | 3.2 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle Pain: Severe | 0 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint Pain: Mild | 2.8 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint Pain: Moderate | 1.6 Percentage of participants |
| Group 1: RSVpreF Lot 1 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint Pain: Severe | 0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Moderate | 4.2 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Moderate | 4.2 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle Pain: Moderate | 12.3 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle Pain: Severe | 0.1 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Severe | 0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Mild | 0.8 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint Pain: Moderate | 6.7 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Moderate | 0.9 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Mild | 1.1 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fever: Severe | 0.3 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Severe | 0.4 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Mild | 21.3 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Severe | 0.1 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Moderate | 21.0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Moderate | 0.5 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Fatigue: Severe | 0.4 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Muscle Pain: Mild | 17.3 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Mild | 21.3 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Vomiting: Severe | 0 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Headache: Moderate | 14.8 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint Pain: Mild | 8.2 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Diarrhea: Mild | 8.9 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Nausea: Mild | 6.3 Percentage of participants |
| Group 2: RSVpreF Lot 2 | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Joint Pain: Severe | 0 Percentage of participants |