Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination |
Geometric mean antibody titers (ELISA units per liter [EU/L]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported. |
14 days after vaccination on Day 1 (Day 15) |
|
| Primary |
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
Until 7 days after Vaccination on Day 1 (Day 8) |
|
| Primary |
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree celsius). |
Until 7 days after Vaccination on Day 1 (Day 8) |
|
| Primary |
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 |
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc). |
Until 28 days after Vaccination on Day 1 (Day 29) |
|
| Secondary |
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 |
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported. |
At 3 and 6 months after vaccination on Day 1 |
|
| Secondary |
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units. |
At 14 days and 3 and 6 months after vaccination on Day 1 |
|
| Secondary |
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides |
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs). |
At 14 days and 3 and 6 months after vaccination on Day 1 |
|
| Secondary |
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. |
Baseline (Day1) up to 6 months |
|
| Secondary |
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. |
Until 7 days after vaccination on Day 1 (Day 8) |
|
| Secondary |
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree celsius). |
Until 7 days after vaccination on Day 1 (Day 8) |
|
| Secondary |
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 |
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc). |
Until 28 days after vaccination on Day 1 (Day 29) |
|
| Secondary |
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported. |
At 14 days and 3 and 6 months after vaccination on Day 1 |
|
| Secondary |
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units. |
At 14 days and 3 and 6 months after vaccination on Day 1 |
|
| Secondary |
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs). |
At 14 days and 3 and 6 months after vaccination on Day 1 |
|
| Secondary |
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. |
Baseline (Day1 ) up to 6 months |
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