A Study to Evaluate the Safety and Ability of the Vaccine... | NCT02298179 | Trialant
NCT02298179
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 13, 2018Actual
Enrollment
288Actual
Phase
Phase 1
Conditions
Respiratory Syncytial Virus (RSV)
Interventions
RSV F subunit 45 μg No adjuvant
RSV F subunit 45 μg Aluminum hydroxide adjuvant
RSV F subunit 45 μg MF59 adjuvant
RSV F subunit 90 μg No adjuvant
RSV F subunit 90 μg Aluminum hydroxide adjuvant
RSV F subunit 90 μg MF59 adjuvant
RSV F subunit 135 μg No adjuvant
RSV F subunit 135 μg Aluminum hydroxide adjuvant
RSV F subunit 135 μg MF59 adjuvant
Placebo
Countries
Belgium
Protocol Section
Identification Module
NCT ID
NCT02298179
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
205219
Secondary IDs
ID
Type
Description
Link
2014-000145-69
EudraCT Number
V122_01
Other Identifier
Novartis
Brief Title
A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults
Official Title
A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 19, 2014Actual
Primary Completion Date
Mar 27, 2017Actual
Completion Date
Mar 27, 2017Actual
First Submitted Date
Nov 19, 2014
First Submission Date that Met QC Criteria
Nov 19, 2014
First Posted Date
Nov 21, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2018
Results First Submitted that Met QC Criteria
Aug 10, 2018
Results First Posted Date
Aug 13, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 10, 2018
Last Update Posted Date
Aug 13, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.
Detailed Description
Not provided
Conditions Module
Conditions
Respiratory Syncytial Virus (RSV)
Keywords
Antibodies
Respiratory syncytial virus
Safety
Healthy adults
Immunogenicity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
288Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
RSV F 45 No Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
Biological: RSV F subunit 45 μg No adjuvant
RSV F 45 Alum Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
Biological: RSV F subunit 45 μg Aluminum hydroxide adjuvant
RSV F 45 MF59 Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Biological: RSV F subunit 45 μg MF59 adjuvant
Placebo 1 Group
Placebo Comparator
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSV F subunit 45 μg No adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).
At Day 57
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).
At Day 57
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Within 30 minutes after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
From Day 1 (6 hour) through Day 3 after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
From Day 4 through Day 7 after each vaccination
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of GMTs of the serum anti-RSV neutralizing antibody (NAb) titers at Day 1, Day 29 (28 days after the first dose) and Day 181 (six months after the first dose).
At Day 1, Day 29 and Day 181
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.
Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
Individuals in good health as determined by the outcome of the medical history, physical examination and clinical judgment of the investigator.
Individuals who can comply with the study procedures and are available for follow up.
Exclusion Criteria:
Individuals with any severe chronic or acute disease.
Individuals with a history of illness or with an ongoing illness that may pose additional risk to the subject if he/she participates in the study, including the following:
History of any chronic respiratory illness, including current diagnosis of asthma within 2 years, exercise induced wheezing, reactive airway disease, emphysema, chronic bronchitis, cystic fibrosis or chronic obstructive pulmonary disease (COPD).
Any respiratory illness within 7 days prior to receiving the first study injection.
Any active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, within 14 days prior to the first study injection.
Hepatitis B or hepatitis C infection.
Individuals who have had a malignancy or lymphoproliferative disorder within the past 5 years.
Individuals with known or suspected impairment of the immune system including but not limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes mellitus.
Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Individuals with a BMI > 35 kg/m2. BMI is to be calculated by the following formula: subject weight at baseline divided by subject height in meters multiplied by the subject height in meters. The numerical result will be rounded to the nearest 0.1.
Individuals who are allergic to any of the vaccine components, or with a history of anaphylaxis after vaccination.
Individuals who during the 90 days prior to enrollment receive any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity.
Individuals who receive systemic immunosuppressive agents including steroids. Prior corticosteroid therapy should be discontinued 28 days prior to enrollment. Individuals using inhaled or topical corticosteroids will be permitted.
Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned receipt or donation during the study period.
Individuals participating in any clinical trial with another investigational product 28 days prior to receiving the first study vaccination or intent to participate in another clinical study at any time during the conduct of this study.
Individuals who have received any vaccine 28 days prior to enrollment in this study, or who plan to receive any non-study vaccines within 28 days of the second dose of study vaccine.
Individuals with any clinically significant abnormal safety laboratory result, as judged by the investigator.
If female, 'of childbearing potential', sexually active and has not used any of the 'acceptable contraceptive methods' for at least two months prior to study entry.
Childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least two years; sterile status after bilateral tubal ligation for at least one year, immediately after bilateral oophorectomy or after hysterectomy.
Acceptable methods of birth control are defined as one or more of the following:
Hormonal contraceptives.
Barrier each and every time during intercourse.
Intrauterine device (IUD).
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to subject's study entry.
If female subject of childbearing potential and have a positive urine pregnancy test prior to study vaccinations, or are currently lactating.
If female of childbearing potential and sexually active, refusal to use an 'acceptable contraceptive method' through to three weeks after last study vaccination.
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Individuals with a history of drug or alcohol abuse within the past 2 years.
Individuals who are acting as study personnel or immediate family members or the spouse of study personnel.
Individuals with a body temperature ≥38 °C (≥100.4◦F) within 3 days of intended study vaccination.
Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives.
Schneikart G, Tavarini S, Sammicheli C, Torricelli G, Guidotti S, Andreano E, Buricchi F, D'Oro U, Finco O, Bardelli M. The respiratory syncytial virus fusion protein-specific B cell receptor repertoire reshaped by post-fusion subunit vaccination. Vaccine. 2020 Nov 25;38(50):7916-7927. doi: 10.1016/j.vaccine.2020.10.062. Epub 2020 Oct 29.
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
Biological: RSV F subunit 90 μg No adjuvant
RSV F 90 Alum Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
Biological: RSV F subunit 90 μg Aluminum hydroxide adjuvant
RSV F 90 MF59 Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
Biological: RSV F subunit 90 μg MF59 adjuvant
Placebo 2 Group
Placebo Comparator
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
Drug: Placebo
RSV F 135 No Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
Biological: RSV F subunit 135 μg No adjuvant
RSV F 135 Alum Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
Biological: RSV F subunit 135 μg Aluminum hydroxide adjuvant
RSV F 135 MF59 Adj Group
Experimental
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
Biological: RSV F subunit 135 μg MF59 adjuvant
Placebo 3 Group
Placebo Comparator
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Drug: Placebo
RSV F 45 No Adj Group
RSV F subunit 45 μg Aluminum hydroxide adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 45 Alum Adj Group
RSV F subunit 45 μg MF59 adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 45 MF59 Adj Group
RSV F subunit 90 μg No adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 90 No Adj Group
RSV F subunit 90 μg Aluminum hydroxide adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 90 Alum Adj Group
RSV F subunit 90 μg MF59 adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 90 MF59 Adj Group
RSV F subunit 135 μg No adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 135 No Adj Group
RSV F subunit 135 μg Aluminum hydroxide adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 135 Alum Adj Group
RSV F subunit 135 μg MF59 adjuvant
Biological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F 135 MF59 Adj Group
Placebo
Drug
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Placebo 1 Group
Placebo 2 Group
Placebo 3 Group
Sterile saline 0.9%
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Within 30 minutes after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
From Day 1 (6 hours) through Day 3 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
From Day 4 through Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
From Day 1 to Day 28 after each vaccination
Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination.
Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment.
From study start (Day 1) until study completion (Day 394)
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers from Day 1 to Day 29 (28 days after the first dose) and from Day 1 to Day 181 (six months after the first dose).
At Day 29 and at Day 181
Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose) with serum anti-RSV NAb titers greater than the 3rd quartile of serum anti-RSV NAb titers at Day 1 (baseline).
At Day 29, Day 57 and Day 181
Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the geometric mean titers (GMTs) of the serum total binding antibody to each of the RSV proteins F, G and N at Day 1 (baseline), Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose).
At Day 1, Day 29, Day 57 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the percentage of subjects with a ≥ 4-fold increase in serum total binding antibody to each of the RSV Proteins F, G and N from Day 1 (baseline) to all time points (Day 29 [28 days after the first dose], Day 57 [28 days after the second dose], and Day 181 [six months after the first dose]).
At Day 29, Day 57 and Day 181
Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose), with serum total binding antibody titers to each of the RSV proteins F, G, and N greater than the 3rd quartile of serum total binding antibody titers to RSV protein F at Day 1 (baseline).
At Day 29, Day 57 and Day 181
Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N
Immunogenicity was measured in terms of the ratio of RSV F serum Nab titers to each of the RSV F serum total binding antibody titers to RSV proteins F, G and N at Days 1, 29, 57 and 181.
At Day 1, Day 29, Day 57 and Day 181
Derived
Leroux-Roels G, De Boever F, Maes C, Nguyen TL, Baker S, Gonzalez Lopez A. Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study. Vaccine. 2019 May 6;37(20):2694-2703. doi: 10.1016/j.vaccine.2019.04.011. Epub 2019 Apr 12.
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
FG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
FG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
FG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
FG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
FG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
FG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
FG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
FG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
FG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
FG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
FG00024 subjects
FG00124 subjects
FG00224 subjects
FG00324 subjects
FG00424 subjects
FG00524 subjects
FG00624 subjects
FG00724 subjects
FG00824 subjects
FG00924 subjects
FG01024 subjects
FG01124 subjects
COMPLETED
FG00024 subjects
FG00124 subjects
FG00223 subjects
FG00324 subjects
FG00424 subjects
FG00524 subjects
FG00624 subjects
FG00723 subjects
FG00824 subjects
FG00924 subjects
FG01024 subjects
FG01124 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
BG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
BG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
BG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
BG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
BG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
BG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
BG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
BG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
BG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
BG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
BG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00124
BG00224
BG00324
BG00424
BG00524
BG00624
BG00724
BG00824
BG00924
BG01024
BG01124
BG012288
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00028.6± 6.8
BG00127.7± 6.55
BG00230.2± 7.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00117
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).
The analysis was based on the Per-Protocol Set (PPS), which included all subjects in the Full Analysis Set (FAS) Immunogenicity population who were not excluded due to the reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 57.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 57
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00022
OG00124
OG00222
OG003
Title
Denominators
Categories
Title
Measurements
OG000864(692 to 1077)
OG001914(738 to 1134)
OG002843(673 to 1057)
OG003
Primary
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).
The analysis was based on PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and and for whom immunogenicity results collected from Day 1 (baseline) up to Day 57 were available at Day 1 and Day 57.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 57
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Primary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
Within 30 minutes after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Primary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
From Day 1 (6 hour) through Day 3 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Primary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
From Day 4 through Day 7 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Primary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
From Day 1 (6 hours) to Day 7 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Primary
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
Within 30 minutes after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Primary
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
From Day 1 (6 hours) through Day 3 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Primary
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
From Day 4 through Day 7 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Primary
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.
Posted
Count of Participants
Participants
From Day 1 (6 hours) to Day 7 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
The analysis was based on the Unsolicited Safety Set, which included all subjects in the Exposed population with unsolicited AE data collected after each vaccination.
Posted
Count of Participants
Participants
From Day 1 to Day 28 after each vaccination
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Primary
Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination.
Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment.
The analysis was based on the Unsolicited Safety Set, which included all subjects in the Exposed population with unsolicited AE data collected from study start (Day 1) until study completion (Day 394).
Posted
Count of Participants
Participants
From study start (Day 1) until study completion (Day 394)
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Secondary
Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of GMTs of the serum anti-RSV neutralizing antibody (NAb) titers at Day 1, Day 29 (28 days after the first dose) and Day 181 (six months after the first dose).
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29 and at Day 181.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1, Day 29 and Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Secondary
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers from Day 1 to Day 29 (28 days after the first dose) and from Day 1 to Day 181 (six months after the first dose).
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29 and Day 181.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 29 and at Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Secondary
Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose) with serum anti-RSV NAb titers greater than the 3rd quartile of serum anti-RSV NAb titers at Day 1 (baseline).
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 29, Day 57 and Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Secondary
Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the geometric mean titers (GMTs) of the serum total binding antibody to each of the RSV proteins F, G and N at Day 1 (baseline), Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose).
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1, Day 29, Day 57 and Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Secondary
Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the percentage of subjects with a ≥ 4-fold increase in serum total binding antibody to each of the RSV Proteins F, G and N from Day 1 (baseline) to all time points (Day 29 [28 days after the first dose], Day 57 [28 days after the second dose], and Day 181 [six months after the first dose]).
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 29, Day 57 and Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Secondary
Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose), with serum total binding antibody titers to each of the RSV proteins F, G, and N greater than the 3rd quartile of serum total binding antibody titers to RSV protein F at Day 1 (baseline).
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.
Posted
Number
95% Confidence Interval
Percentage of subjects
At Day 29, Day 57 and Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
Secondary
Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N
Immunogenicity was measured in terms of the ratio of RSV F serum Nab titers to each of the RSV F serum total binding antibody titers to RSV proteins F, G and N at Days 1, 29, 57 and 181.
The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.
Posted
Geometric Mean
95% Confidence Interval
Adjusted Geometric Mean Ratio
At Day 1, Day 29, Day 57 and Day 181
ID
Title
Description
OG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
OG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Time Frame
Solicited local and systemic symptoms: from Day 1 (6 hours) through Day 7 after each vaccination; Unsolicited AEs: from Day 1 through Day 28 after each vaccination; SAEs: from study start (Day 1) to study completion (Day 394).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
RSV F 45 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
0
24
1
24
23
24
EG001
RSV F 45 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
0
24
1
24
24
24
EG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
0
24
1
24
24
24
EG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
0
24
0
24
23
24
EG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
0
24
1
24
24
24
EG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
0
24
0
24
24
24
EG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
0
24
4
24
24
24
EG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
0
24
0
24
21
24
EG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
0
24
1
24
23
24
EG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
0
24
2
24
24
24
EG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
0
24
0
24
23
24
EG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
0
24
0
24
22
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected24 at risk
EG0080 events0 affected24 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected24 at risk
EG0110 events0 affected24 at risk
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected24 at risk
EG0081 events1 affected24 at risk
EG0092 events2 affected24 at risk
EG0101 events1 affected24 at risk
EG0110 events0 affected24 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0009 events7 affected24 at risk
EG0011 events1 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0006 events4 affected24 at risk
EG0014 events3 affected24 at risk
EG0025 events5 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0013 events2 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0024 events4 affected24 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Injection site pain
General disorders
MedDRA 20.1
Systematic Assessment
EG00027 events18 affected24 at risk
EG00132 events21 affected24 at risk
EG00232 events19 affected24 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG00013 events9 affected24 at risk
EG00114 events10 affected24 at risk
EG00220 events13 affected24 at risk
EG003
Injection site induration
General disorders
MedDRA 20.1
Systematic Assessment
EG0009 events8 affected24 at risk
EG0017 events6 affected24 at risk
EG0028 events7 affected24 at risk
EG003
Injection site erythema
General disorders
MedDRA 20.1
Systematic Assessment
EG00010 events8 affected24 at risk
EG0016 events5 affected24 at risk
EG0024 events4 affected24 at risk
EG003
Injection site swelling
General disorders
MedDRA 20.1
Systematic Assessment
EG0004 events4 affected24 at risk
EG0013 events3 affected24 at risk
EG0025 events3 affected24 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0011 events1 affected24 at risk
EG0026 events6 affected24 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0011 events1 affected24 at risk
EG0027 events6 affected24 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0013 events3 affected24 at risk
EG0021 events1 affected24 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected24 at risk
EG0011 events1 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0013 events3 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Hangover
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG00016 events11 affected24 at risk
EG00114 events12 affected24 at risk
EG00211 events10 affected24 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0003 events3 affected24 at risk
EG0015 events4 affected24 at risk
EG0023 events3 affected24 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0015 events2 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0013 events3 affected24 at risk
EG0025 events5 affected24 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected24 at risk
EG0011 events1 affected24 at risk
EG0024 events4 affected24 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Ear infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected24 at risk
EG0010 events0 affected24 at risk
EG0022 events2 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0004 events3 affected24 at risk
EG0010 events0 affected24 at risk
EG0024 events4 affected24 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected24 at risk
EG0014 events4 affected24 at risk
EG0027 events5 affected24 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0012 events2 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG00014 events11 affected24 at risk
EG00126 events11 affected24 at risk
EG00210 events9 affected24 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0011 events1 affected24 at risk
EG0024 events2 affected24 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG00025 events12 affected24 at risk
EG00131 events11 affected24 at risk
EG00224 events12 affected24 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG00015 events8 affected24 at risk
EG00110 events6 affected24 at risk
EG00215 events9 affected24 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0004 events4 affected24 at risk
EG0016 events4 affected24 at risk
EG0025 events5 affected24 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0005 events3 affected24 at risk
EG0011 events1 affected24 at risk
EG0022 events1 affected24 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected24 at risk
EG0010 events0 affected24 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00022
OG00124
OG00222
OG00323
OG00424
OG00524
OG00622
OG00723
OG00823
OG00922
OG01024
OG01124
Title
Denominators
Categories
Title
Measurements
OG00045(24.4 to 67.8)
OG00154(32.8 to 74.4)
OG00236(17.2 to 59.3)
OG0030(0.0 to 14.8)
OG00425(9.8 to 46.7)
OG00529(12.6 to 51.1)
OG00641(20.7 to 63.6)
OG0070(0.0 to 14.8)
OG00817(5.0 to 38.8)
OG00945(24.4 to 67.8)
OG01046(25.6 to 67.2)
OG0110(0.0 to 14.2)
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Induration (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any Swelling (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Erythema (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Pain (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Induration (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Swelling (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Erythema (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Pain (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Induration (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0000
OG0013
OG0022
OG003
Any Swelling (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Erythema (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Pain (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Induration (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Swelling (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Erythema (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Pain (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Induration (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0000
OG0011
OG0020
OG003
Any Swelling (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Erythema (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Pain (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Induration (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Swelling (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Erythema (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Pain (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Induration (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0000
OG0014
OG0022
OG003
Any Swelling (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Erythema (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Pain (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Induration (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Swelling (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Erythema (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Pain (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Nausea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0000
OG0011
OG0020
OG003
Any Fatigue (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Myalgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Arthralgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Headache (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Fever (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Chills (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Coughing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Diarrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Rhinorrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Wheezing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever prevention (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever treatment (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Nausea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fatigue (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Myalgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Arthralgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Headache (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fever (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Chills (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Coughing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Diarrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Rhinorrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Wheezing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever prevention (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever treatment (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Nausea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0001
OG0011
OG0023
OG003
Any Fatigue (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Myalgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Arthralgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Headache (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Fever (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Chills (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Coughing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Diarrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Rhinorrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Wheezing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever prevention (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever treatment (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Nausea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fatigue (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Myalgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Arthralgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Headache (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fever (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Chills (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Coughing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Diarrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Rhinorrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Wheezing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever prevention (2nd)
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever treatment (2nd)
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Nausea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0001
OG0010
OG0020
OG003
Any Fatigue (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Myalgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Arthralgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Headache (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Fever (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Chills (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Coughing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Diarrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Rhinorrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Wheezing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever prevention (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever treatment (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Nausea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fatigue (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Myalgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Arthralgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Headache (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fever (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Chills (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Coughing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Diarrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Rhinorrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Wheezing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever prevention (2nd)
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever treatment (2nd)
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any Nausea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG0002
OG0011
OG0023
OG003
Any Fatigue (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Myalgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Arthralgia (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Headache (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Fever (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Chills (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Coughing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Diarrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Rhinorrhea (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Wheezing (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever prevention (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Pain/Fever treatment (1st)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
Any Nausea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fatigue (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Myalgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Arthralgia (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Headache (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Fever (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Chills (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Coughing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Diarrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Rhinorrhea (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Any Wheezing (2nd)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever prevention (2nd)
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Pain/Fever treatment (2nd)
ParticipantsOG00023
ParticipantsOG00123
ParticipantsOG00223
ParticipantsOG00324
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any AE(s) (1st vacc.)
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00224
ParticipantsOG00324
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00624
ParticipantsOG00724
ParticipantsOG00824
ParticipantsOG00924
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG00017
OG00115
OG00214
OG003
Any AE(s) (2nd vacc.)
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00324
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00024
OG00124
OG00224
OG00324
OG00424
OG00524
OG00624
OG00724
OG00824
OG00924
OG01024
OG01124
Title
Denominators
Categories
Any SAE(s)
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0041
OG0050
OG0064
OG0070
OG0081
OG0092
OG0100
OG0110
Possibly/probably related SAE(s)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any medically attended AE(s)
Title
Measurements
OG00010
OG00111
OG00212
OG003
Any AE(s) leading to study withdrawal
Title
Measurements
OG0001
OG0010
OG0020
OG003
Any NOCD(s)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any AESI(s)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00323
OG00424
OG00524
OG00622
OG00724
OG00823
OG00923
OG01024
OG01124
Title
Denominators
Categories
Anti-RSV NAb, Day 1
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00823
ParticipantsOG00923
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG000237(162 to 345)
OG001184(127 to 266)
OG002340(233 to 497)
OG003
Anti-RSV NAb, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
Anti-RSV NAb, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00323
OG00424
OG00524
OG00622
OG00724
OG00823
OG00923
OG01024
OG01124
Title
Denominators
Categories
Anti-RSV NAb, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00823
ParticipantsOG00923
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG00048(26.8 to 69.4)
OG00158(36.6 to 77.9)
OG00230(13.2 to 52.9)
OG003
Anti-RSV NAb, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00323
OG00424
OG00524
OG00622
OG00724
OG00823
OG00923
OG01024
OG01124
Title
Denominators
Categories
Anti-RSV NAb, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00823
ParticipantsOG00923
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG00078(56.3 to 92.5)
OG00183(62.6 to 95.3)
OG002100(85.2 to 100.0)
OG003
Anti-RSV NAb, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
Anti-RSV NAb, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00323
OG00424
OG00524
OG00622
OG00724
OG00823
OG00923
OG01024
OG01124
Title
Denominators
Categories
RSV Protein F, Day 1
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00823
ParticipantsOG00923
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG000671(470 to 958)
OG001838(591 to 1188)
OG002916(642 to 1309)
OG003
RSV Protein F, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein F, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein F, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein Ga, Day 1
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Ga, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Ga, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein Ga, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein Gb, Day 1
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Gb, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Gb, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein Gb, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein N, Day 1
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein N, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein N, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein N, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00323
OG00424
OG00524
OG00622
OG00724
OG00823
OG00923
OG01024
OG01124
Title
Denominators
Categories
RSV Protein F, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00823
ParticipantsOG00923
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG00083(61.2 to 95.0)
OG00192(73.0 to 99.0)
OG00296(78.1 to 99.89)
OG003
RSV Protein F, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein F, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein Ga, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Ga, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein Ga, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein Gb, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Gb, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein Gb, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein N, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein N, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein N, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
OG002
RSV F 45 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.
Units
Counts
Participants
OG00023
OG00124
OG00223
OG00323
OG00424
OG00524
OG00622
OG00724
OG00823
OG00923
OG01024
OG01124
Title
Denominators
Categories
RSV Protein F, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
ParticipantsOG00424
ParticipantsOG00524
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00823
ParticipantsOG00923
ParticipantsOG01024
ParticipantsOG01124
Title
Measurements
OG00096(78.1 to 99.89)
OG001100(85.8 to 100.0)
OG002100(85.2 to 100.0)
OG003
RSV Protein F, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein F, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein Ga, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Ga, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein Ga, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein Gb, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein Gb, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein Gb, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
RSV Protein N, Day 29
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00223
ParticipantsOG00323
RSV Protein N, Day 57
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00323
RSV Protein N, Day 181
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00222
ParticipantsOG00322
OG003
Placebo 1 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
OG004
RSV F 90 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
OG005
RSV F 90 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
OG006
RSV F 90 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
OG007
Placebo 2 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
OG008
RSV F 135 No Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
OG009
RSV F 135 Alum Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
OG010
RSV F 135 MF59 Adj Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
OG011
Placebo 3 Group
Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.