Study Description

Study Design

Groups and Cohorts

Outcome Measures

Primary Outcome Measures

1. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine [From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]]
   First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.

Secondary Outcome Measures

1. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine [From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemishpere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])]
   Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.
   
   The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
2. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine [From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])]
   Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.
   
   The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
3. Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine [From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 3 years in the NH and 2.5-3 years in Southern Hemisphere [SH])]
   Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.
   
   Results for the entire study period will be updated at the final results disclosure stage.
4. Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine [From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])]
   Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.
   
   The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
5. Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine [From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])]
   Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR.
   
   Results for the entire study period will be updated at the final results disclosure stage.
6. Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine [From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])]
   Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR.
   
   The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
7. Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
   Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: ≥65 YOA, ≥70 YOA and ≥80 YOA.
   
   Results for LRTD by age will be updated at the final results disclosure stage.
8. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first-vaccination or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season]
   Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from at least one-month post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data.
   
   Results for LRTD by Season will be updated at the final results disclosure stage.
9. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination)]
   Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from at least one month post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year.
   
   Results for LRTD by year will be updated during final result posting stage.
10. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities (such as COPD, asthma, any chronic respiratory or pulmonary disease, diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease) and according to Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index).
    
    Results for LRTD by baseline comorbidities will be updated at the final results disclosure stage.
11. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed <0.4m/s or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed >=1 m/s.
    
    Results for LRTD by baseline frailty status will be updated at the final results disclosure stage.
12. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first and each revaccination dose to the first occurrence of RSV severe LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (case definition 2) and with at least one RSV positive swab detected by RT-PCR.
    
    Results for severe LRTD will be updated at the final results disclosure stage.
13. Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (ARI) Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR.
    
    Results for RSV A and/or B Associated ARI will be updated at the final results disclosure stage.
14. Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From Day 15 post first vaccination up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against any ARI and any LRTD.
    
    Results for the entire study period will be updated at the final results disclosure stage.
15. Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])]
    A diagnosis of respiratory disease include: acute respiratory illnesses, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system.
    
    Results for the entire study period will be updated at the final results disclosure stage.
16. Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])]
    RSV infection was confirmed by RT-PCR. Results for this outcome measure is not disclosed at this stage in order to maintain blinding within the ongoing trial. Data will be added at the final results posting stage.
17. Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])]
    RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
18. Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)]
    The Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- Nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score is computed as the mean score across all 32 items, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). Results for the entire study period will be updated at the final results disclosure stage.
19. Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)]
    Individual questions are assessed on the 5-point response categories and Flu-PRO total score is tabulated.
    
    Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
20. EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [At the ARI visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)]
    The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group. Values range from 0 (worst) to 1 (full health).
    
    Results for the entire study period will be updated at the final results disclosure stage.
21. Short Form-12 (SF-12) Physical Functioning Score for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses [At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)]
    SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
    
    Results for the entire study period will be updated at the final results disclosure stage.
22. Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes [Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    The duration in days of RT-PCR confirmed RSV ARI and LRTD episodes will be described.
    
    Results for the entire study period will be updated at the final results disclosure stage.
23. Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes [Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
24. Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes [Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
25. Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity [Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])]
    RSV A and/or B ARI and LRTD episodes assessed as 'severe' by the investigator. Severe is defined as "An ARI/LRTD episode which prevents normal, everyday activities. Such an event would, for example, prevent attendance at work and would necessitate the administration of corrective therapy".
    
    Number of subjects with Severe ARI and Severe LRTD episodes has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.
    
    Results for the entire study period will be updated at the final results disclosure stage
26. RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations [At Day 1 (Pre-Dose 1) and Day 31]
    The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
27. RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations [Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)]
    The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
28. RSV A Neutralizing Antibody Titers [At Day 1 (Pre-Dose 1) and Day 31]
    RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).
29. RSV A Neutralizing Antibody Titers [Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)]
    RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
30. RSV B Neutralizing Antibody Titers [At Day 1 (Pre-Dose 1) and Day 31]
    RSV B neutralizing antibodies are given as GMTs.
31. RSV B Neutralizing Antibody Titers [Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)]
    RSV B neutralizing antibodies are given as GMTs. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
32. Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events [During the 4-day follow up period after first vaccination (vaccine administered on Day 1)]
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.
    
    Number of participants with grade 3 AEs has not been disclosed at this stage in order to maintain blinding within the ongoing trial. Those will be added at the final results posting stage.
33. Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events [During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)]
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
34. Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events [During the 4-day follow up period after the third vaccination (administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))]
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
35. Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events [During the 4-day follow up period after first vaccination (vaccine administered on Day 1)]
    The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
    
    Number of subjects with Grade 3 Fever and Grade 3 Headache has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.
36. Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events [During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)]
    The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
37. Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events [During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere)]
    The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
38. Number of Days With Solicited Administration Site Adverse Events [During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)]
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.
39. Number of Days With Solicited Administration Site Adverse Events [During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)]
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
40. Number of Days With Solicited Administration Site Adverse Events [During the 4-day follow up period after third vaccination (vaccine administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))]
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
41. Number of Days With Solicited Systemic Adverse Events [During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)]
    The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
42. Number of Days With Solicited Systemic Adverse Events [During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)]
    The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
43. Number of Days With Solicited Systemic Adverse Events [During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])]
    The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
44. Number of Participants With Any Unsolicited AEs [During the 30-day follow up period after first vaccination (vaccine or placebo administered on Day 1)]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
45. Number of Participants With Any Unsolicited AEs [During the 30-day follow up period after second vaccination (vaccine administered pre-season 2)]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
46. Number of Participants With Any Unsolicited AEs [During the 30-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
47. Number of Participants With Serious Adverse Events (SAEs) [From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])]
    An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
48. Number of Participants With Potential Immune Mediated Diseases (pIMDs) [From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])]
    pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    
    The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
49. Number of Participants With Related SAEs and Fatal SAEs [From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])]
    Related SAEs and fatal SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to deaths. Results for the entire study period will be updated at the final results disclosure stage.
50. Number of Participants With Related pIMDs [From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])]
    pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
    
    Results for the entire study period will be updated at the final results disclosure stage.

Eligibility Criteria

Contacts and Locations

Study Documents (Full Text)

• Documents Provided by GlaxoSmithKline: Study Protocol January 24, 2022
• Documents Provided by GlaxoSmithKline: Statistical Analysis Plan December 20, 2022

More Information

Publications

• Michael G Ison, Alberto Papi, Eugene Athan, Robert G Feldman, Joanne M Langley, Dong-Gun Lee, Isabel Leroux-Roels, Federico Martinon-Torres, Tino F Schwarz, Richard N van Zyl-Smit, Céline Verheust, Nancy Dezutter, Olivier Gruselle, Laurence Fissette, Marie-Pierre David, Lusine Kostanyan, Veronica Hulstrøm, Aurélie Olivier, Marie Van der Wielen, Dominique Descamps, for the AReSVi-006 Study Group , Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons, Clinical Infectious Diseases, 2024 Jan 22:ciae010; DOI: 10.1093/cid/ciae010 PMID: 38253338

Additional Relevant MeSH Terms

• Respiratory Syncytial Virus Infections
• Virus Diseases
• Infections
• Pneumovirus Infections
• Paramyxoviridae Infections
• Mononegavirales Infections
• RNA Virus Infections