A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02298179
• Collaborator: (none)
• Enrollment: 288
• Location: 1
• Arms: 12
• Actual Duration (Months): 27.2
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus (RSV)	Biological: RSV F subunit 45 μg No adjuvant; Biological: RSV F subunit 45 μg Aluminum hydroxide adjuvant; Biological: RSV F subunit 45 μg MF59 adjuvant; Biological: RSV F subunit 90 μg No adjuvant; Biological: RSV F subunit 90 μg Aluminum hydroxide adjuvant; Biological: RSV F subunit 90 μg MF59 adjuvant; Biological: RSV F subunit 135 μg No adjuvant; Biological: RSV F subunit 135 μg Aluminum hydroxide adjuvant; Biological: RSV F subunit 135 μg MF59 adjuvant; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Dec 19, 2014
• Actual Primary Completion Date: Mar 27, 2017
• Actual Study Completion Date: Mar 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: RSV F subunit 45 μg No adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Experimental: 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.	Biological: RSV F subunit 45 μg Aluminum hydroxide adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Experimental: 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.	Biological: RSV F subunit 45 μg MF59 adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Placebo Comparator: 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.	Drug: Placebo; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; Other Names: Sterile saline 0.9%
Experimental: 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.	Biological: RSV F subunit 90 μg No adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Experimental: 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.	Biological: RSV F subunit 90 μg Aluminum hydroxide adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Experimental: 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.	Biological: RSV F subunit 90 μg MF59 adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Placebo Comparator: 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.	Drug: Placebo; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; Other Names: Sterile saline 0.9%
Experimental: 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.	Biological: RSV F subunit 135 μg No adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Experimental: 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.	Biological: RSV F subunit 135 μg Aluminum hydroxide adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Experimental: 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.	Biological: RSV F subunit 135 μg MF59 adjuvant; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
Placebo Comparator: 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.	Drug: Placebo; 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.; Other Names: Sterile saline 0.9%

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers [At Day 57]

   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).

2. Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers [At Day 57]

   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).

3. Number of Subjects With Any Solicited Local Symptoms [Within 30 minutes after each vaccination]

   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.

4. Number of Subjects With Any Solicited Local Symptoms [From Day 1 (6 hour) through Day 3 after each vaccination]

   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.

5. Number of Subjects With Any Solicited Local Symptoms [From Day 4 through Day 7 after each vaccination]

   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.

6. Number of Subjects With Any Solicited Local Symptoms [From Day 1 (6 hours) to Day 7 after each vaccination]

   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.

7. Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [Within 30 minutes after each vaccination]

   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.

8. Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [From Day 1 (6 hours) through Day 3 after each vaccination]

   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.

9. Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [From Day 4 through Day 7 after each vaccination]

   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.

10. Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity [From Day 1 (6 hours) to Day 7 after each vaccination]

    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.

11. Number of Subjects With Unsolicited Adverse Events (AEs) [From Day 1 to Day 28 after each vaccination]

    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.

12. Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s) [From study start (Day 1) until study completion (Day 394)]

    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.

Secondary Outcome Measures

1. Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers [At Day 1, Day 29 and Day 181]

   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).

2. Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer [At Day 29 and at Day 181]

   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).

3. Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1 [At Day 29, Day 57 and Day 181]

   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).

4. Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N [At Day 1, Day 29, Day 57 and Day 181]

   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).

5. Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N [At Day 29, Day 57 and Day 181]

   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]).

6. 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 [At Day 29, Day 57 and Day 181]

   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).

7. 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 Day 1, Day 29, Day 57 and Day 181]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.

2. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.

3. Individuals in good health as determined by the outcome of the medical history, physical examination and clinical judgment of the investigator.

4. Individuals who can comply with the study procedures and are available for follow up.

Exclusion Criteria:

1. Individuals with any severe chronic or acute disease.

2. 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.

1. Individuals who have had a malignancy or lymphoproliferative disorder within the past 5 years.

2. Individuals with known or suspected impairment of the immune system including but not limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes mellitus.

3. Individuals with any history of progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.

4. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

5. 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.

6. Individuals who are allergic to any of the vaccine components, or with a history of anaphylaxis after vaccination.

7. 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.

8. 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.

9. Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned receipt or donation during the study period.

10. 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.

11. 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.

12. Individuals with any clinically significant abnormal safety laboratory result, as judged by the investigator.

13. 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.

1. If female subject of childbearing potential and have a positive urine pregnancy test prior to study vaccinations, or are currently lactating.

2. If female of childbearing potential and sexually active, refusal to use an 'acceptable contraceptive method' through to three weeks after last study vaccination.

3. 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.

4. Individuals with a history of drug or alcohol abuse within the past 2 years.

5. Individuals who are acting as study personnel or immediate family members or the spouse of study personnel.

6. Individuals with a body temperature ≥38 °C (≥100.4◦F) within 3 days of intended study vaccination.

7. Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ghent		Belgium	9000

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Apr 12, 2016
• Statistical Analysis Plan - Oct 18, 2017

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02298179
• Other Study ID Numbers: 205219; 2014-000145-69; V122_01
• First Posted: Nov 21, 2014
• Last Update Posted: Aug 13, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by GlaxoSmithKline: Antibodies; Respiratory syncytial virus; Safety; Healthy adults; Immunogenicity
• Additional relevant MeSH terms: Aluminum Hydroxide; MF59 oil emulsion

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled from one site in Belgium.
Pre-assignment Detail	All subjects enrolled were included in the trial.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	24	24	24	24	24	24	24	24	24	24	24	24
COMPLETED	24	24	23	24	24	24	24	23	24	24	24	24
NOT COMPLETED	0	0	1	0	0	0	0	1	0	0	0	0

Baseline Characteristics

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group	Total
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	24	24	24	24	24	24	24	24	24	24	24	24	288
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	28.6 (6.8)	27.7 (6.55)	30.2 (7.9)	30.3 (7.62)	30.4 (8.31)	31.2 (7.47)	27.6 (6.84)	28 (7.3)	28.3 (6.8)	29.5 (6.98)	32.9 (8.46)	27.9 (5.86)	29.13 (7.24)
Sex: Female, Male (Count of Participants)
Female	20 83.3%	17 70.8%	18 75%	18 75%	16 66.7%	18 75%	15 62.5%	14 58.3%	22 91.7%	18 75%	20 83.3%	20 83.3%	216 75%
Male	4 16.7%	7 29.2%	6 25%	6 25%	8 33.3%	6 25%	9 37.5%	10 41.7%	2 8.3%	6 25%	4 16.7%	4 16.7%	72 25%
Race/Ethnicity, Customized (Count of Participants)
BLACK OR AFRICAN AMERICAN	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	2 0.7%
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.3%
WHITE	23 95.8%	22 91.7%	24 100%	24 100%	24 100%	24 100%	24 100%	23 95.8%	24 100%	24 100%	24 100%	24 100%	284 98.6%
NOT SPECIFIED	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Description	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).
Time Frame	At Day 57

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	22	24	22	23	24	24	22	23	23	22	24	24
Geometric Mean (95% Confidence Interval) [Titers]	864	914	843	234	844	746	944	253	903	1212	1316	254

2. Primary Outcome

Title	Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers
Description	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).
Time Frame	At Day 57

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	22	24	22	23	24	24	22	23	23	22	24	24
Number (95% Confidence Interval) [Percentage of subjects]	45	54	36	0	25	29	41	0	17	45	46	0

3. Primary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	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.
Time Frame	Within 30 minutes after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Induration (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Erythema (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain (1st)	3 12.5%	1 4.2%	0 0%	3 12.5%	1 4.2%	4 16.7%	4 16.7%	2 8.3%	2 8.3%	2 8.3%	1 4.2%	3 12.5%
Any Induration (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Erythema (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain (2nd)	2 8.3%	0 0%	1 4.2%	1 4.2%	0 0%	2 8.3%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	2 8.3%

4. Primary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	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.
Time Frame	From Day 1 (6 hour) through Day 3 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Induration (1st)	0 0%	3 12.5%	2 8.3%	0 0%	1 4.2%	2 8.3%	3 12.5%	0 0%	0 0%	2 8.3%	2 8.3%	1 4.2%
Any Swelling (1st)	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	2 8.3%	0 0%	2 8.3%	0 0%	1 4.2%	0 0%
Any Erythema (1st)	1 4.2%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	2 8.3%	0 0%	0 0%	1 4.2%	0 0%	0 0%
Any Pain (1st)	12 50%	21 87.5%	19 79.2%	2 8.3%	10 41.7%	18 75%	20 83.3%	2 8.3%	12 50%	22 91.7%	18 75%	5 20.8%
Any Induration (2nd)	0 0%	0 0%	1 4.2%	0 0%	1 4.2%	1 4.2%	0 0%	0 0%	2 8.3%	0 0%	1 4.2%	1 4.2%
Any Swelling (2nd)	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	2 8.3%	1 4.2%	0 0%	0 0%
Any Erythema (2nd)	1 4.2%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain (2nd)	13 54.2%	11 45.8%	13 54.2%	4 16.7%	16 66.7%	12 50%	13 54.2%	0 0%	15 62.5%	11 45.8%	14 58.3%	5 20.8%

5. Primary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	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.
Time Frame	From Day 4 through Day 7 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Induration (1st)	0 0%	1 4.2%	0 0%	0 0%	1 4.2%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	1 4.2%	0 0%	0 0%	0 0%
Any Erythema (1st)	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain (1st)	8 33.3%	7 29.2%	4 16.7%	0 0%	7 29.2%	8 33.3%	3 12.5%	0 0%	9 37.5%	5 20.8%	4 16.7%	0 0%
Any Induration (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Swelling (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Erythema (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain (2nd)	2 8.3%	1 4.2%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%

6. Primary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	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.
Time Frame	From Day 1 (6 hours) to Day 7 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Induration (1st)	0 0%	4 16.7%	2 8.3%	0 0%	1 4.2%	2 8.3%	3 12.5%	0 0%	0 0%	2 8.3%	2 8.3%	1 4.2%
Any Swelling (1st)	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	2 8.3%	0 0%	2 8.3%	0 0%	1 4.2%	0 0%
Any Erythema (1st)	1 4.2%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	2 8.3%	0 0%	0 0%	1 4.2%	0 0%	0 0%
Any Pain (1st)	14 58.3%	21 87.5%	19 79.2%	2 8.3%	11 45.8%	18 75%	20 83.3%	2 8.3%	13 54.2%	22 91.7%	18 75%	5 20.8%
Any Induration (2nd)	0 0%	0 0%	1 4.2%	0 0%	1 4.2%	1 4.2%	0 0%	0 0%	2 8.3%	0 0%	1 4.2%	1 4.2%
Any Swelling (2nd)	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	2 8.3%	1 4.2%	0 0%	0 0%
Any Erythema (2nd)	1 4.2%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Pain (2nd)	13 54.2%	11 45.8%	13 54.2%	4 16.7%	16 66.7%	12 50%	13 54.2%	0 0%	15 62.5%	11 45.8%	14 58.3%	5 20.8%

7. Primary Outcome

Title	Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Description	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.
Time Frame	Within 30 minutes after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Nausea (1st)	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%
Any Fatigue (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Myalgia (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Arthralgia (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Headache (1st)	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Fever (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Chills (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Coughing (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Diarrhea (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Rhinorrhea (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Wheezing (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever prevention (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (1st)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Nausea (2nd)	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Fatigue (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Myalgia (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Arthralgia (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Headache (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Fever (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Chills (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Coughing (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Diarrhea (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Rhinorrhea (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Wheezing (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever prevention (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

8. Primary Outcome

Title	Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Description	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.
Time Frame	From Day 1 (6 hours) through Day 3 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Nausea (1st)	1 4.2%	1 4.2%	3 12.5%	2 8.3%	4 16.7%	0 0%	1 4.2%	1 4.2%	1 4.2%	3 12.5%	4 16.7%	2 8.3%
Any Fatigue (1st)	6 25%	7 29.2%	8 33.3%	8 33.3%	7 29.2%	7 29.2%	9 37.5%	7 29.2%	4 16.7%	7 29.2%	7 29.2%	5 20.8%
Any Myalgia (1st)	1 4.2%	1 4.2%	4 16.7%	0 0%	1 4.2%	3 12.5%	3 12.5%	0 0%	2 8.3%	5 20.8%	4 16.7%	0 0%
Any Arthralgia (1st)	3 12.5%	0 0%	4 16.7%	0 0%	2 8.3%	2 8.3%	1 4.2%	0 0%	1 4.2%	1 4.2%	3 12.5%	1 4.2%
Any Headache (1st)	6 25%	5 20.8%	1 4.2%	5 20.8%	5 20.8%	6 25%	7 29.2%	5 20.8%	4 16.7%	7 29.2%	9 37.5%	2 8.3%
Any Fever (1st)	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any Chills (1st)	2 8.3%	1 4.2%	5 20.8%	0 0%	2 8.3%	1 4.2%	0 0%	1 4.2%	2 8.3%	3 12.5%	3 12.5%	0 0%
Any Coughing (1st)	5 20.8%	3 12.5%	2 8.3%	1 4.2%	0 0%	3 12.5%	0 0%	0 0%	0 0%	4 16.7%	4 16.7%	4 16.7%
Any Diarrhea (1st)	4 16.7%	0 0%	0 0%	3 12.5%	4 16.7%	2 8.3%	2 8.3%	1 4.2%	0 0%	4 16.7%	3 12.5%	0 0%
Any Rhinorrhea (1st)	7 29.2%	5 20.8%	4 16.7%	4 16.7%	5 20.8%	3 12.5%	4 16.7%	6 25%	3 12.5%	8 33.3%	6 25%	4 16.7%
Any Wheezing (1st)	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	0 0%
Pain/Fever prevention (1st)	0 0%	0 0%	1 4.2%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (1st)	3 12.5%	0 0%	0 0%	0 0%	4 16.7%	1 4.2%	2 8.3%	0 0%	1 4.2%	2 8.3%	3 12.5%	1 4.2%
Any Nausea (2nd)	1 4.2%	1 4.2%	1 4.2%	2 8.3%	2 8.3%	3 12.5%	1 4.2%	4 16.7%	1 4.2%	2 8.3%	1 4.2%	2 8.3%
Any Fatigue (2nd)	3 12.5%	4 16.7%	6 25%	6 25%	7 29.2%	4 16.7%	1 4.2%	6 25%	3 12.5%	3 12.5%	6 25%	5 20.8%
Any Myalgia (2nd)	1 4.2%	0 0%	1 4.2%	3 12.5%	1 4.2%	1 4.2%	0 0%	1 4.2%	1 4.2%	0 0%	2 8.3%	1 4.2%
Any Arthralgia (2nd)	1 4.2%	0 0%	0 0%	3 12.5%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	2 8.3%	0 0%
Any Headache (2nd)	3 12.5%	4 16.7%	6 25%	4 16.7%	6 25%	5 20.8%	0 0%	5 20.8%	3 12.5%	4 16.7%	4 16.7%	1 4.2%
Any Fever (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%
Any Chills (2nd)	1 4.2%	0 0%	1 4.2%	2 8.3%	0 0%	2 8.3%	0 0%	1 4.2%	1 4.2%	0 0%	0 0%	2 8.3%
Any Coughing (2nd)	2 8.3%	3 12.5%	3 12.5%	2 8.3%	2 8.3%	1 4.2%	1 4.2%	1 4.2%	2 8.3%	1 4.2%	3 12.5%	1 4.2%
Any Diarrhea (2nd)	1 4.2%	1 4.2%	0 0%	3 12.5%	1 4.2%	1 4.2%	0 0%	3 12.5%	0 0%	2 8.3%	1 4.2%	2 8.3%
Any Rhinorrhea (2nd)	6 25%	8 33.3%	3 12.5%	3 12.5%	3 12.5%	2 8.3%	3 12.5%	1 4.2%	2 8.3%	3 12.5%	5 20.8%	4 16.7%
Any Wheezing (2nd)	0 0%	0 0%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever prevention (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (2nd)	2 8.3%	3 12.5%	2 8.3%	3 12.5%	1 4.2%	3 12.5%	0 0%	0 0%	2 8.3%	3 12.5%	1 4.2%	1 4.2%

9. Primary Outcome

Title	Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Description	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.
Time Frame	From Day 4 through Day 7 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Nausea (1st)	1 4.2%	0 0%	0 0%	1 4.2%	1 4.2%	2 8.3%	2 8.3%	2 8.3%	1 4.2%	2 8.3%	3 12.5%	3 12.5%
Any Fatigue (1st)	2 8.3%	3 12.5%	6 25%	8 33.3%	4 16.7%	5 20.8%	7 29.2%	7 29.2%	4 16.7%	4 16.7%	5 20.8%	4 16.7%
Any Myalgia (1st)	1 4.2%	0 0%	1 4.2%	2 8.3%	1 4.2%	2 8.3%	2 8.3%	1 4.2%	1 4.2%	0 0%	2 8.3%	1 4.2%
Any Arthralgia (1st)	2 8.3%	0 0%	0 0%	1 4.2%	1 4.2%	1 4.2%	1 4.2%	0 0%	0 0%	1 4.2%	2 8.3%	1 4.2%
Any Headache (1st)	3 12.5%	1 4.2%	1 4.2%	7 29.2%	4 16.7%	6 25%	7 29.2%	7 29.2%	2 8.3%	4 16.7%	4 16.7%	3 12.5%
Any Fever (1st)	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	1 4.2%
Any Chills (1st)	1 4.2%	0 0%	2 8.3%	0 0%	1 4.2%	1 4.2%	2 8.3%	1 4.2%	0 0%	1 4.2%	2 8.3%	1 4.2%
Any Coughing (1st)	7 29.2%	3 12.5%	6 25%	1 4.2%	3 12.5%	4 16.7%	4 16.7%	1 4.2%	3 12.5%	7 29.2%	5 20.8%	6 25%
Any Diarrhea (1st)	2 8.3%	0 0%	0 0%	0 0%	2 8.3%	1 4.2%	0 0%	1 4.2%	1 4.2%	1 4.2%	2 8.3%	0 0%
Any Rhinorrhea (1st)	7 29.2%	6 25%	8 33.3%	6 25%	4 16.7%	6 25%	6 25%	6 25%	3 12.5%	7 29.2%	9 37.5%	6 25%
Any Wheezing (1st)	2 8.3%	0 0%	0 0%	0 0%	2 8.3%	1 4.2%	1 4.2%	0 0%	0 0%	2 8.3%	0 0%	1 4.2%
Pain/Fever prevention (1st)	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (1st)	1 4.2%	0 0%	0 0%	0 0%	2 8.3%	2 8.3%	2 8.3%	0 0%	1 4.2%	0 0%	1 4.2%	1 4.2%
Any Nausea (2nd)	0 0%	1 4.2%	0 0%	1 4.2%	0 0%	1 4.2%	0 0%	5 20.8%	4 16.7%	2 8.3%	2 8.3%	3 12.5%
Any Fatigue (2nd)	5 20.8%	3 12.5%	2 8.3%	3 12.5%	5 20.8%	2 8.3%	1 4.2%	3 12.5%	2 8.3%	2 8.3%	5 20.8%	3 12.5%
Any Myalgia (2nd)	0 0%	0 0%	1 4.2%	2 8.3%	0 0%	0 0%	0 0%	2 8.3%	1 4.2%	1 4.2%	1 4.2%	1 4.2%
Any Arthralgia (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	1 4.2%	1 4.2%	1 4.2%
Any Headache (2nd)	2 8.3%	5 20.8%	0 0%	4 16.7%	5 20.8%	2 8.3%	3 12.5%	2 8.3%	3 12.5%	3 12.5%	3 12.5%	4 16.7%
Any Fever (2nd)	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%
Any Chills (2nd)	1 4.2%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	2 8.3%	0 0%	1 4.2%	1 4.2%
Any Coughing (2nd)	3 12.5%	2 8.3%	3 12.5%	3 12.5%	3 12.5%	1 4.2%	0 0%	0 0%	1 4.2%	4 16.7%	1 4.2%	2 8.3%
Any Diarrhea (2nd)	1 4.2%	0 0%	0 0%	2 8.3%	1 4.2%	0 0%	1 4.2%	3 12.5%	0 0%	2 8.3%	2 8.3%	1 4.2%
Any Rhinorrhea (2nd)	7 29.2%	4 16.7%	3 12.5%	5 20.8%	5 20.8%	4 16.7%	3 12.5%	2 8.3%	3 12.5%	5 20.8%	2 8.3%	4 16.7%
Any Wheezing (2nd)	1 4.2%	1 4.2%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	0 0%
Pain/Fever prevention (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (2nd)	0 0%	1 4.2%	0 0%	2 8.3%	1 4.2%	1 4.2%	1 4.2%	1 4.2%	1 4.2%	0 0%	0 0%	3 12.5%

10. Primary Outcome

Title	Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Description	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.
Time Frame	From Day 1 (6 hours) to Day 7 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any Nausea (1st)	2 8.3%	1 4.2%	3 12.5%	3 12.5%	5 20.8%	2 8.3%	3 12.5%	3 12.5%	2 8.3%	4 16.7%	5 20.8%	3 12.5%
Any Fatigue (1st)	7 29.2%	8 33.3%	10 41.7%	10 41.7%	9 37.5%	10 41.7%	10 41.7%	8 33.3%	5 20.8%	7 29.2%	9 37.5%	7 29.2%
Any Myalgia (1st)	1 4.2%	1 4.2%	5 20.8%	2 8.3%	2 8.3%	5 20.8%	4 16.7%	1 4.2%	3 12.5%	5 20.8%	4 16.7%	1 4.2%
Any Arthralgia (1st)	3 12.5%	0 0%	4 16.7%	1 4.2%	3 12.5%	2 8.3%	2 8.3%	0 0%	1 4.2%	2 8.3%	4 16.7%	2 8.3%
Any Headache (1st)	7 29.2%	5 20.8%	2 8.3%	11 45.8%	8 33.3%	9 37.5%	10 41.7%	9 37.5%	5 20.8%	9 37.5%	10 41.7%	5 20.8%
Any Fever (1st)	1 4.2%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	1 4.2%
Any Chills (1st)	2 8.3%	1 4.2%	5 20.8%	0 0%	3 12.5%	2 8.3%	2 8.3%	1 4.2%	2 8.3%	4 16.7%	4 16.7%	1 4.2%
Any Coughing (1st)	8 33.3%	5 20.8%	6 25%	2 8.3%	3 12.5%	5 20.8%	4 16.7%	1 4.2%	3 12.5%	7 29.2%	6 25%	6 25%
Any Diarrhea (1st)	4 16.7%	0 0%	0 0%	3 12.5%	5 20.8%	2 8.3%	2 8.3%	2 8.3%	1 4.2%	4 16.7%	4 16.7%	0 0%
Any Rhinorrhea (1st)	8 33.3%	9 37.5%	9 37.5%	7 29.2%	7 29.2%	7 29.2%	7 29.2%	10 41.7%	4 16.7%	9 37.5%	10 41.7%	6 25%
Any Wheezing (1st)	2 8.3%	0 0%	0 0%	0 0%	2 8.3%	1 4.2%	1 4.2%	0 0%	0 0%	2 8.3%	1 4.2%	1 4.2%
Pain/Fever prevention (1st)	0 0%	0 0%	2 8.3%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (1st)	3 12.5%	0 0%	0 0%	0 0%	5 20.8%	2 8.3%	4 16.7%	0 0%	2 8.3%	2 8.3%	3 12.5%	2 8.3%
Any Nausea (2nd)	1 4.2%	2 8.3%	1 4.2%	2 8.3%	2 8.3%	3 12.5%	1 4.2%	6 25%	5 20.8%	4 16.7%	3 12.5%	3 12.5%
Any Fatigue (2nd)	6 25%	5 20.8%	7 29.2%	7 29.2%	8 33.3%	4 16.7%	2 8.3%	6 25%	4 16.7%	4 16.7%	8 33.3%	6 25%
Any Myalgia (2nd)	1 4.2%	0 0%	1 4.2%	3 12.5%	1 4.2%	1 4.2%	0 0%	2 8.3%	2 8.3%	1 4.2%	2 8.3%	1 4.2%
Any Arthralgia (2nd)	1 4.2%	0 0%	0 0%	3 12.5%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	2 8.3%	2 8.3%	1 4.2%
Any Headache (2nd)	4 16.7%	7 29.2%	6 25%	6 25%	9 37.5%	5 20.8%	3 12.5%	6 25%	5 20.8%	7 29.2%	6 25%	4 16.7%
Any Fever (2nd)	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	1 4.2%
Any Chills (2nd)	2 8.3%	0 0%	1 4.2%	2 8.3%	0 0%	2 8.3%	0 0%	1 4.2%	2 8.3%	0 0%	1 4.2%	2 8.3%
Any Coughing (2nd)	3 12.5%	3 12.5%	4 16.7%	4 16.7%	4 16.7%	2 8.3%	1 4.2%	1 4.2%	2 8.3%	4 16.7%	3 12.5%	2 8.3%
Any Diarrhea (2nd)	2 8.3%	1 4.2%	0 0%	3 12.5%	1 4.2%	1 4.2%	1 4.2%	3 12.5%	0 0%	3 12.5%	2 8.3%	3 12.5%
Any Rhinorrhea (2nd)	7 29.2%	8 33.3%	4 16.7%	5 20.8%	6 25%	5 20.8%	3 12.5%	2 8.3%	4 16.7%	6 25%	6 25%	6 25%
Any Wheezing (2nd)	1 4.2%	1 4.2%	1 4.2%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 4.2%	0 0%
Pain/Fever prevention (2nd)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pain/Fever treatment (2nd)	2 8.3%	3 12.5%	2 8.3%	4 16.7%	2 8.3%	3 12.5%	1 4.2%	1 4.2%	2 8.3%	3 12.5%	1 4.2%	3 12.5%

11. Primary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	From Day 1 to Day 28 after each vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any AE(s) (1st vacc.)	17 70.8%	15 62.5%	14 58.3%	17 70.8%	15 62.5%	14 58.3%	16 66.7%	14 58.3%	13 54.2%	14 58.3%	15 62.5%	17 70.8%
Any AE(s) (2nd vacc.)	8 33.3%	12 50%	16 66.7%	13 54.2%	13 54.2%	7 29.2%	6 25%	13 54.2%	10 41.7%	9 37.5%	13 54.2%	10 41.7%

12. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)
Description	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.
Time Frame	From study start (Day 1) until study completion (Day 394)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	24	24	24	24	24	24	24	24	24	24	24	24
Any SAE(s)	1 4.2%	1 4.2%	1 4.2%	0 0%	1 4.2%	0 0%	4 16.7%	0 0%	1 4.2%	2 8.3%	0 0%	0 0%
Possibly/probably related SAE(s)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any medically attended AE(s)	10 41.7%	11 45.8%	12 50%	17 70.8%	17 70.8%	9 37.5%	16 66.7%	15 62.5%	15 62.5%	15 62.5%	12 50%	11 45.8%
Any AE(s) leading to study withdrawal	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%
Any NOCD(s)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Any AESI(s)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	0 0%	0 0%	0 0%	0 0%

13. Secondary Outcome

Title	Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Description	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).
Time Frame	At Day 1, Day 29 and Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
Anti-RSV NAb, Day 1	237	184	340	215	289	280	254	233	338	332	380	292
Anti-RSV NAb, Day 29	893	947	983	236	1110	981	1208	242	1123	1602	1551	286
Anti-RSV NAb, Day 181	576	587	450	234	684	627	597	260	687	788	764	248

14. Secondary Outcome

Title	Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer
Description	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).
Time Frame	At Day 29 and at Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
Anti-RSV NAb, Day 29	48	58	30	0	25	42	50	0	35	57	42	0
Anti-RSV NAb, Day 181	32	29	5	0	17	14	15	0	14	27	17	0

15. Secondary Outcome

Title	Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1
Description	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).
Time Frame	At Day 29, Day 57 and Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
Anti-RSV NAb, Day 29	78	83	100	17	92	92	91	13	91	100	100	25
Anti-RSV NAb, Day 57	95	79	95	9	83	79	95	17	91	91	100	25
Anti-RSV NAb, Day 181	64	50	64	18	87	73	65	13	68	82	74	17

16. Secondary Outcome

Title	Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Description	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).
Time Frame	At Day 1, Day 29, Day 57 and Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
RSV Protein F, Day 1	671	838	916	714	697	730	751	727	880	685	910	750
RSV Protein F, Day 29	9641	11131	11639	675	13017	10694	12841	684	13252	13514	13541	851
RSV Protein F, Day 57	8064	9707	10182	757	11470	10131	11588	660	11302	13483	12158	791
RSV Protein F, Day 181	4904	6584	5312	690	6908	6271	5824	763	6157	8651	7041	833
RSV Protein Ga, Day 1	64	57	60	44	53	55	48	57	55	51	65	49
RSV Protein Ga, Day 29	64	55	59	43	50	47	46	51	59	47	57	55
RSV Protein Ga, Day 57	62	53	55	42	49	46	44	46	60	43	51	52
RSV Protein Ga, Day 181	61	55	58	40	49	54	47	60	54	45	53	49
RSV Protein Gb, Day 1	109	105	120	99	107	97	123	100	104	91	112	80
RSV Protein Gb, Day 29	122	96	112	102	95	92	87	90	107	97	109	91
RSV Protein Gb, Day 57	123	97	106	109	93	89	89	78	106	87	89	87
RSV Protein Gb, Day 181	106	94	101	98	99	112	93	101	102	94	98	87
RSV Protein N, Day 1	480	525	586	444	418	486	508	424	462	417	569	392
RSV Protein N, Day 29	592	434	467	418	439	470	443	412	524	417	471	456
RSV Protein N, Day 57	580	461	513	457	396	423	401	345	514	426	439	418
RSV Protein N, Day 181	524	391	420	421	397	484	425	454	493	454	458	439

17. Secondary Outcome

Title	Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Description	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]).
Time Frame	At Day 29, Day 57 and Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
RSV Protein F, Day 29	83	92	96	0	100	92	86	0	87	100	100	0
RSV Protein F, Day 57	86	92	95	0	100	92	86	0	87	100	100	0
RSV Protein F, Day 181	73	79	68	0	100	73	75	0	73	100	83	0
RSV Protein Ga, Day 29	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein Ga, Day 57	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein Ga, Day 181	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein Gb, Day 29	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein Gb, Day 57	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein Gb, Day 181	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein N, Day 29	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein N, Day 57	0	0	0	0	0	0	0	0	0	0	0	0
RSV Protein N, Day 181	0	0	0	0	0	0	0	0	0	0	0	0

18. Secondary Outcome

Title	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
Description	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).
Time Frame	At Day 29, Day 57 and Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
RSV Protein F, Day 29	96	100	100	22	100	100	100	21	100	100	100	29
RSV Protein F, Day 57	95	100	100	30	100	100	100	13	100	100	100	25
RSV Protein F, Day 181	91	100	95	23	100	100	100	17	100	100	100	21
RSV Protein Ga, Day 29	30	38	22	22	25	21	14	29	35	13	29	38
RSV Protein Ga, Day 57	27	38	23	22	25	17	14	22	39	14	25	38
RSV Protein Ga, Day 181	45	38	23	18	22	23	30	22	18	18	30	21
RSV Protein Gb, Day 29	30	21	30	26	21	17	23	38	30	17	42	25
RSV Protein Gb, Day 57	36	17	27	39	21	17	27	22	35	23	21	25
RSV Protein Gb, Day 181	32	17	23	18	30	27	20	22	27	18	30	21
RSV Protein N, Day 29	39	25	35	9	21	25	23	25	26	17	29	33
RSV Protein N, Day 57	45	33	50	17	8	25	27	9	22	14	21	17
RSV Protein N, Day 181	32	25	32	5	13	36	30	22	23	9	26	17

19. Secondary Outcome

Title	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
Description	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.
Time Frame	At Day 1, Day 29, Day 57 and Day 181

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	RSV F 45 No Adj Group	RSV F 45 Alum Adj Group	RSV F 45 MF59 Adj Group	Placebo 1 Group	RSV F 90 No Adj Group	RSV F 90 Alum Adj Group	RSV F 90 MF59 Adj Group	Placebo 2 Group	RSV F 135 No Adj Group	RSV F 135 Alum Adj Group	RSV F 135 MF59 Adj Group	Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Measure Participants	23	24	23	23	24	24	22	24	23	23	24	24
RSV Protein F, Day 1	2.79	3.95	3.18	3.32	2.48	2.64	2.83	3.13	2.55	2.00	2.51	2.57
RSV Protein F, Day 29	10	12	12	2.86	12	10	11	2.82	9.83	9.21	9.56	2.98
RSV Protein F, Day 57	8.95	11	12	3.24	13	13	13	2.61	11	11	11	3.11
RSV Protein F, Day 181	8.37	13	11	2.96	10	9.76	9.91	2.93	8.78	11	9.58	3.36
RSV Protein Ga, Day 1	0.27	0.27	0.20	0.21	0.19	0.20	0.18	0.25	0.16	0.15	0.18	0.17
RSV Protein Ga, Day 29	0.073	0.056	0.061	0.18	0.047	0.045	0.039	0.21	0.043	0.029	0.045	0.19
RSV Protein Ga, Day 57	0.076	0.057	0.063	0.18	0.059	0.058	0.049	0.18	0.056	0.034	0.047	0.20
RSV Protein Ga, Day 181	0.12	0.095	0.11	0.17	0.076	0.097	0.065	0.23	0.074	0.054	0.078	0.20
RSV Protein Gb, Day 1	0.45	0.48	0.43	0.46	0.38	0.35	0.46	0.43	0.30	0.26	0.31	0.27
RSV Protein Gb, Day 29	0.13	0.099	0.12	0.43	0.086	0.076	0.090	0.37	0.079	0.061	0.083	0.32
RSV Protein Gb, Day 57	0.14	0.11	0.13	0.47	0.11	0.098	0.12	0.31	0.10	0.068	0.081	0.34
RSV Protein Gb, Day 181	0.19	0.17	0.21	0.42	0.16	0.17	0.15	0.39	0.15	0.11	0.14	0.35
RSV Protein N, Day 1	1.99	2.40	2.10	2.07	1.51	1.76	1.88	1.82	1.34	1.21	1.59	1.34
RSV Protein N, Day 29	0.59	0.47	0.52	1.77	0.36	0.44	0.44	1.70	0.36	0.26	0.39	1.60
RSV Protein N, Day 57	0.62	0.53	0.63	1.96	0.43	0.53	0.51	1.36	0.46	0.33	0.43	1.65
RSV Protein N, Day 181	0.87	0.73	0.89	1.80	0.54	0.81	0.73	1.75	0.65	0.54	0.69	1.77

Adverse Events

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).
Arm/Group Title	RSV F 45 No Adj Group		RSV F 45 Alum Adj Group		RSV F 45 MF59 Adj Group		Placebo 1 Group		RSV F 90 No Adj Group		RSV F 90 Alum Adj Group		RSV F 90 MF59 Adj Group		Placebo 2 Group		RSV F 135 No Adj Group		RSV F 135 Alum Adj Group		RSV F 135 MF59 Adj Group		Placebo 3 Group
Arm/Group Description	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 low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.		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.		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.		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.		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.		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.		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.		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.		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.		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.		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.
All Cause Mortality
	RSV F 45 No Adj Group		RSV F 45 Alum Adj Group		RSV F 45 MF59 Adj Group		Placebo 1 Group		RSV F 90 No Adj Group		RSV F 90 Alum Adj Group		RSV F 90 MF59 Adj Group		Placebo 2 Group		RSV F 135 No Adj Group		RSV F 135 Alum Adj Group		RSV F 135 MF59 Adj Group		Placebo 3 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)		0/24 (0%)
Serious Adverse Events
	RSV F 45 No Adj Group		RSV F 45 Alum Adj Group		RSV F 45 MF59 Adj Group		Placebo 1 Group		RSV F 90 No Adj Group		RSV F 90 Alum Adj Group		RSV F 90 MF59 Adj Group		Placebo 2 Group		RSV F 135 No Adj Group		RSV F 135 Alum Adj Group		RSV F 135 MF59 Adj Group		Placebo 3 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/24 (4.2%)		1/24 (4.2%)		1/24 (4.2%)		0/24 (0%)		1/24 (4.2%)		0/24 (0%)		4/24 (16.7%)		0/24 (0%)		1/24 (4.2%)		2/24 (8.3%)		0/24 (0%)		0/24 (0%)
Endocrine disorders
Basedow's disease	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Gastrointestinal disorders
Pancreatitis acute	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Immune system disorders
Anaphylactic shock	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0
Infections and infestations
Pyelonephritis	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Pyelonephritis acute	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Injury, poisoning and procedural complications
Cartilage injury	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Head injury	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Psychiatric disorders
Depression	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0
Reproductive system and breast disorders
Vaginal haemorrhage	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Vascular disorders
Deep vein thrombosis	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Other (Not Including Serious) Adverse Events
	RSV F 45 No Adj Group		RSV F 45 Alum Adj Group		RSV F 45 MF59 Adj Group		Placebo 1 Group		RSV F 90 No Adj Group		RSV F 90 Alum Adj Group		RSV F 90 MF59 Adj Group		Placebo 2 Group		RSV F 135 No Adj Group		RSV F 135 Alum Adj Group		RSV F 135 MF59 Adj Group		Placebo 3 Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/24 (95.8%)		24/24 (100%)		24/24 (100%)		23/24 (95.8%)		24/24 (100%)		24/24 (100%)		24/24 (100%)		21/24 (87.5%)		23/24 (95.8%)		24/24 (100%)		23/24 (95.8%)		22/24 (91.7%)
Blood and lymphatic system disorders
Lymphadenopathy	3/24 (12.5%)	4	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	2/24 (8.3%)	2	1/24 (4.2%)	1	0/24 (0%)	0
Gastrointestinal disorders
Diarrhoea	7/24 (29.2%)	9	1/24 (4.2%)	1	1/24 (4.2%)	1	8/24 (33.3%)	9	5/24 (20.8%)	7	2/24 (8.3%)	4	3/24 (12.5%)	3	4/24 (16.7%)	7	1/24 (4.2%)	1	6/24 (25%)	8	5/24 (20.8%)	9	4/24 (16.7%)	4
Nausea	4/24 (16.7%)	6	3/24 (12.5%)	4	5/24 (20.8%)	5	5/24 (20.8%)	7	7/24 (29.2%)	8	7/24 (29.2%)	9	5/24 (20.8%)	6	9/24 (37.5%)	13	7/24 (29.2%)	8	5/24 (20.8%)	8	7/24 (29.2%)	9	5/24 (20.8%)	7
Dyspepsia	0/24 (0%)	0	2/24 (8.3%)	2	1/24 (4.2%)	1	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Toothache	0/24 (0%)	0	2/24 (8.3%)	3	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Abdominal pain	0/24 (0%)	0	0/24 (0%)	0	4/24 (16.7%)	4	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	3/24 (12.5%)	5
Gastrointestinal disorder	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	1/24 (4.2%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Tooth disorder	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Gingival pain	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Gastritis	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0
General disorders
Injection site pain	18/24 (75%)	27	21/24 (87.5%)	32	19/24 (79.2%)	32	8/24 (33.3%)	9	17/24 (70.8%)	27	21/24 (87.5%)	32	22/24 (91.7%)	36	5/24 (20.8%)	5	20/24 (83.3%)	30	23/24 (95.8%)	33	19/24 (79.2%)	32	8/24 (33.3%)	12
Fatigue	9/24 (37.5%)	13	10/24 (41.7%)	14	13/24 (54.2%)	20	13/24 (54.2%)	24	10/24 (41.7%)	23	14/24 (58.3%)	16	12/24 (50%)	16	11/24 (45.8%)	22	9/24 (37.5%)	13	7/24 (29.2%)	16	12/24 (50%)	21	9/24 (37.5%)	16
Injection site induration	8/24 (33.3%)	9	6/24 (25%)	7	7/24 (29.2%)	8	1/24 (4.2%)	2	6/24 (25%)	7	9/24 (37.5%)	10	6/24 (25%)	8	0/24 (0%)	0	8/24 (33.3%)	9	9/24 (37.5%)	13	7/24 (29.2%)	11	3/24 (12.5%)	4
Injection site erythema	8/24 (33.3%)	10	5/24 (20.8%)	6	4/24 (16.7%)	4	3/24 (12.5%)	4	5/24 (20.8%)	5	5/24 (20.8%)	10	5/24 (20.8%)	8	2/24 (8.3%)	2	4/24 (16.7%)	6	8/24 (33.3%)	11	4/24 (16.7%)	5	5/24 (20.8%)	7
Injection site swelling	4/24 (16.7%)	4	3/24 (12.5%)	3	3/24 (12.5%)	5	1/24 (4.2%)	2	2/24 (8.3%)	2	2/24 (8.3%)	3	6/24 (25%)	7	0/24 (0%)	0	8/24 (33.3%)	11	3/24 (12.5%)	4	3/24 (12.5%)	4	2/24 (8.3%)	2
Chills	3/24 (12.5%)	4	1/24 (4.2%)	1	6/24 (25%)	6	2/24 (8.3%)	2	3/24 (12.5%)	3	4/24 (16.7%)	5	2/24 (8.3%)	2	1/24 (4.2%)	3	3/24 (12.5%)	6	4/24 (16.7%)	4	5/24 (20.8%)	5	3/24 (12.5%)	3
Influenza like illness	2/24 (8.3%)	2	1/24 (4.2%)	1	6/24 (25%)	7	1/24 (4.2%)	1	1/24 (4.2%)	1	1/24 (4.2%)	1	4/24 (16.7%)	4	1/24 (4.2%)	1	3/24 (12.5%)	3	4/24 (16.7%)	4	1/24 (4.2%)	1	3/24 (12.5%)	3
Injection site haemorrhage	1/24 (4.2%)	1	3/24 (12.5%)	3	1/24 (4.2%)	1	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Pyrexia	1/24 (4.2%)	2	1/24 (4.2%)	1	2/24 (8.3%)	2	2/24 (8.3%)	3	2/24 (8.3%)	2	1/24 (4.2%)	1	2/24 (8.3%)	2	1/24 (4.2%)	1	0/24 (0%)	0	1/24 (4.2%)	1	2/24 (8.3%)	2	2/24 (8.3%)	2
Malaise	0/24 (0%)	0	3/24 (12.5%)	3	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Hangover	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Infections and infestations
Upper respiratory tract infection	11/24 (45.8%)	16	12/24 (50%)	14	10/24 (41.7%)	11	11/24 (45.8%)	15	10/24 (41.7%)	19	13/24 (54.2%)	15	9/24 (37.5%)	12	9/24 (37.5%)	13	9/24 (37.5%)	10	10/24 (41.7%)	11	5/24 (20.8%)	8	9/24 (37.5%)	12
Rhinitis	3/24 (12.5%)	3	4/24 (16.7%)	5	3/24 (12.5%)	3	7/24 (29.2%)	8	7/24 (29.2%)	10	7/24 (29.2%)	7	3/24 (12.5%)	4	12/24 (50%)	14	0/24 (0%)	0	1/24 (4.2%)	1	3/24 (12.5%)	4	0/24 (0%)	0
Cystitis	2/24 (8.3%)	2	2/24 (8.3%)	5	2/24 (8.3%)	2	1/24 (4.2%)	3	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	2/24 (8.3%)	2	2/24 (8.3%)	2	1/24 (4.2%)	2
Gastroenteritis	1/24 (4.2%)	1	3/24 (12.5%)	3	5/24 (20.8%)	5	5/24 (20.8%)	6	3/24 (12.5%)	3	3/24 (12.5%)	3	3/24 (12.5%)	3	5/24 (20.8%)	6	4/24 (16.7%)	5	3/24 (12.5%)	3	4/24 (16.7%)	4	4/24 (16.7%)	4
Pharyngitis	1/24 (4.2%)	2	1/24 (4.2%)	1	4/24 (16.7%)	4	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Conjunctivitis	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Ear infection	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Otitis media	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	3/24 (12.5%)	3	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Influenza	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	2/24 (8.3%)	2	2/24 (8.3%)	2	1/24 (4.2%)	1	1/24 (4.2%)	1	1/24 (4.2%)	1	2/24 (8.3%)	2	1/24 (4.2%)	1
Tonsillitis	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	1/24 (4.2%)	1	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Tinea pedis	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Sinusitis	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	3/24 (12.5%)	4	1/24 (4.2%)	2	2/24 (8.3%)	2	1/24 (4.2%)	2	2/24 (8.3%)	2
Oral herpes	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	3	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Bronchitis	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	2/24 (8.3%)	2	0/24 (0%)	0
Injury, poisoning and procedural complications
Procedural pain	1/24 (4.2%)	1	0/24 (0%)	0	2/24 (8.3%)	2	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	3/24 (12.5%)	4	0/24 (0%)	0	4/24 (16.7%)	4	4/24 (16.7%)	4	4/24 (16.7%)	4	2/24 (8.3%)	2	2/24 (8.3%)	2	1/24 (4.2%)	1	4/24 (16.7%)	4	3/24 (12.5%)	6	4/24 (16.7%)	6	3/24 (12.5%)	3
Myalgia	2/24 (8.3%)	2	4/24 (16.7%)	4	5/24 (20.8%)	7	6/24 (25%)	6	3/24 (12.5%)	3	5/24 (20.8%)	6	4/24 (16.7%)	4	2/24 (8.3%)	3	4/24 (16.7%)	5	5/24 (20.8%)	6	5/24 (20.8%)	8	2/24 (8.3%)	2
Musculoskeletal stiffness	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Tendonitis	0/24 (0%)	0	1/24 (4.2%)	1	0/24 (0%)	0	3/24 (12.5%)	3	2/24 (8.3%)	2	1/24 (4.2%)	1	1/24 (4.2%)	1	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0
Back pain	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	2/24 (8.3%)	2	4/24 (16.7%)	4	1/24 (4.2%)	1
Nervous system disorders
Headache	11/24 (45.8%)	14	11/24 (45.8%)	26	9/24 (37.5%)	10	14/24 (58.3%)	23	14/24 (58.3%)	31	11/24 (45.8%)	21	11/24 (45.8%)	23	12/24 (50%)	24	11/24 (45.8%)	19	11/24 (45.8%)	21	13/24 (54.2%)	21	10/24 (41.7%)	13
Dizziness	0/24 (0%)	0	1/24 (4.2%)	1	2/24 (8.3%)	4	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	1/24 (4.2%)	1	3/24 (12.5%)	3	1/24 (4.2%)	1
Tension headache	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	3
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	12/24 (50%)	25	11/24 (45.8%)	31	12/24 (50%)	24	11/24 (45.8%)	21	11/24 (45.8%)	14	9/24 (37.5%)	15	8/24 (33.3%)	13	11/24 (45.8%)	14	9/24 (37.5%)	12	10/24 (41.7%)	21	12/24 (50%)	22	11/24 (45.8%)	17
Cough	8/24 (33.3%)	15	6/24 (25%)	10	9/24 (37.5%)	15	8/24 (33.3%)	10	8/24 (33.3%)	10	8/24 (33.3%)	11	5/24 (20.8%)	6	2/24 (8.3%)	3	5/24 (20.8%)	7	9/24 (37.5%)	17	7/24 (29.2%)	14	10/24 (41.7%)	12
Oropharyngeal pain	4/24 (16.7%)	4	4/24 (16.7%)	6	5/24 (20.8%)	5	2/24 (8.3%)	2	3/24 (12.5%)	3	1/24 (4.2%)	1	3/24 (12.5%)	3	5/24 (20.8%)	6	1/24 (4.2%)	2	4/24 (16.7%)	6	6/24 (25%)	7	5/24 (20.8%)	7
Wheezing	3/24 (12.5%)	5	1/24 (4.2%)	1	1/24 (4.2%)	2	1/24 (4.2%)	2	2/24 (8.3%)	2	1/24 (4.2%)	1	1/24 (4.2%)	1	0/24 (0%)	0	0/24 (0%)	0	3/24 (12.5%)	3	2/24 (8.3%)	2	1/24 (4.2%)	1
Dysphonia	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	2/24 (8.3%)	2	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0	0/24 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.