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Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04886596
Recruitment Status : Active, not recruiting
First Posted : May 14, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSVPreF3 OA Lot 1 Biological: RSVPreF3 OA Lot 2 Biological: RSVPreF3 OA Lot 3 Biological: RSVPreF3 OA Lot 4 Drug: Placebo Biological: RSVPreF3 OA vaccine Phase 3

Detailed Description:
Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26665 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is an observer blind study.
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Actual Study Start Date : May 25, 2021
Actual Primary Completion Date : April 11, 2022
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RSVPreF3_L1 Group
Participants in this group receive lot 1 of the RSVPreF3 OA vaccine (Dose 1).
Biological: RSVPreF3 OA Lot 1
Lot 1 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 to the RSVPreF3_L1 Group (Part 1)

Experimental: RSVPreF3_L2 Group
Participants in this group receive lot 2 of the RSVPreF3 OA vaccine (Dose 1).
Biological: RSVPreF3 OA Lot 2
Lot 2 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 to the RSVPreF3_L2 Group (Part 1)

Experimental: RSVPreF3_L3 Group
Participants in this group receive lot 3 of the RSVPreF3 OA vaccine (Dose 1).
Biological: RSVPreF3 OA Lot 3
Lot 3 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 to the RSVPreF3_L3 Group (Part 1)

Experimental: RSVPreF3_L4 Group
Participants in this group receive lot 4 of the RSVPreF3 OA vaccine (Dose 1).
Biological: RSVPreF3 OA Lot 4
Lot 4 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 to the RSVPreF3_L4 Group (Part 2)

Placebo Comparator: Placebo Group
Participants in this group receive 1 dose of placebo at day 1 and an additional dose of placebo every subsequent year.
Drug: Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 to Placebo Group and before each subsequent RSV season to the RSV_1dose and Placebo groups.

Experimental: RSV_L1_annual Group
Participants in this group are re-randomized from the RSVPreF3_L1 Group to receive an additional dose of the RSVPreF3 OA vaccine.
Biological: RSVPreF3 OA vaccine
Revaccination doses of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm before each subsequent RSV season to the RSV_annual groups.

Experimental: RSV_L2_annual Group
Participants in this group are re-randomized from the RSVPreF3_L2 Group to receive an additional dose of the RSVPreF3 OA vaccine.
Biological: RSVPreF3 OA vaccine
Revaccination doses of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm before each subsequent RSV season to the RSV_annual groups.

Experimental: RSV_L3_annual Group
Participants in this group are re-randomized from the RSVPreF3_L3 Group to receive an additional dose of the RSVPreF3 OA vaccine.
Biological: RSVPreF3 OA vaccine
Revaccination doses of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm before each subsequent RSV season to the RSV_annual groups.

Experimental: RSV_L4_annual Group
Participants in this group are re-randomized from the RSVPreF3_L4 Group to receive an additional dose of the RSVPreF3 OA vaccine.
Biological: RSVPreF3 OA vaccine
Revaccination doses of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm before each subsequent RSV season to the RSV_annual groups.

Experimental: RSV_L1_1dose Group
Participants in this group are re-randomized from the RSVPreF3_L1 Group to receive a dose of placebo.
Drug: Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 to Placebo Group and before each subsequent RSV season to the RSV_1dose and Placebo groups.

Experimental: RSV_L2_1dose Group
Participants in this group are re-randomized from the RSVPreF3_L2 Group to receive a dose of placebo.
Drug: Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 to Placebo Group and before each subsequent RSV season to the RSV_1dose and Placebo groups.

Experimental: RSV_L3_1 dose Group
Participants in this group are re-randomized from the RSVPreF3_L3 Group to receive a dose of placebo.
Drug: Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 to Placebo Group and before each subsequent RSV season to the RSV_1dose and Placebo groups.

Experimental: RSV_L4_1dose Group
Participants in this group are re-randomized from the RSVPreF3_L4 Group to receive a dose of placebo.
Drug: Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 to Placebo Group and before each subsequent RSV season to the RSV_1dose and Placebo groups.




Primary Outcome Measures :
  1. Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD during the first season season following a single dose of the RSVPreF3 OA vaccine in adults ≥ 60 YOA [ Time Frame: From 2 weeks post-first vaccination until until the efficacy data lock point for analysis, triggered by at least 56 cases accrued (assessed approximately over 7 to 10 months) ]
    First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season is assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of lower respiratory symptoms/ signs for at least 24 hours and 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 [ Time Frame: From 2 weeks post-first vaccination over several seasons (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of a single dose of the RSVPreF3 OA vaccine is assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.

  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 [ Time Frame: From 2 weeks post each revaccination dose over several seasons (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine is assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition.

  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 [ Time Frame: From 2 weeks post first vaccination over 3 seasons (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of a single dose of the RSVPreF3 OA vaccine is assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.

  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 [ Time Frame: From 2 weeks post each revaccination dose over 3 seasons (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine is assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition.

  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 [ Time Frame: From 2 weeks post first vaccination over 3 seasons (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]

    Efficacy of a single dose of the RSVPreF3 OA vaccine is 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.


  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 [ Time Frame: From 2 weeks post each revaccination dose over 3 seasons (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]

    Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine is 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.


  7. Number of participants with first episode of RT-PCR confirmed RSV subtype A and subtype B LRTD following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses [ Time Frame: From 2 weeks post first and each revaccination dose to the first occurrence of LRTD caused by RSV A and B subtype (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against LRTD episode caused by RSV A and B subtype in adults ≥ 60 years of age according to the case definition.

  8. Number of participants with first episode of RT-PCR confirmed LRTD caused by other respiratory pathogens following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses [ Time Frame: From 2 weeks post first and each revaccination dose to the first occurrence of LRTD caused by other respiratory pathogens (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]

    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against LRTD episode caused by other respiratory pathogens.

    An LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR.


  9. 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 [ Time Frame: From 2 weeks post first and each revaccination dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is 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.

  10. 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 [ Time Frame: From 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 is 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.

  11. 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 [ Time Frame: From 2 weeks post first and each revaccination dose until end of year 1 (Month 12), year 2 (Month 12 to Month 24) and year 3 (Month 24 until study end) ]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is 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.

  12. Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD following a single dose of the RSVPreF3 OA vaccine [ Time Frame: From 2 weeks post first vaccination to first occurrence of RSV LRTD over time (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
  13. 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 [ Time Frame: From 2 weeks post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in NH and 2.5-3 years in 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.

  14. 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 [ Time Frame: From 2 weeks post first and each revaccination dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in NH and 2.5-3 years in 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 frailty status of frail, pre-frail and fit.

  15. 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 [ Time Frame: From 2 weeks post first and each revaccination dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in NH and 2.5-3 years in 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. Case definition for RSV-confirmed severe LRTD:

    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 (Severe LRTD 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 (Severe LRTD case definition 2) and with at least one RSV positive swab detected by RT-PCR.


  16. Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated Acute Respiratory Infection (ARI) following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses [ Time Frame: From 2 weeks post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in NH and 2.5-3 years in 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.

  17. 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 [ Time Frame: From 2 weeks post first and each revaccination dose to the first occurrence of any ARI or any LRTD (assessed approximately over 3 years in NH and 2.5-3 years in SH) ]
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against any ARI and any LRTD.

  18. 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 [ Time Frame: During the 3 RSV seasons in NH and at least 2 RSV seasons in SH (approximately 7 months for each season) ]
  19. 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 [ Time Frame: During the 3 RSV seasons in NH and at least 2 RSV seasons in SH (approximately 7 months for each season) ]
  20. 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 [ Time Frame: During the 3 RSV seasons in NH and at least 2 RSV seasons in SH (approximately 7 months for each season) ]
  21. 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 [ Time Frame: During the first 7 days from the onset of ARI symptoms ]
    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).

  22. 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 [ Time Frame: During the first 7 days from the onset of ARI symptoms ]
    Individual questions are assessed on the 5-point response categories and Flu-PRO total score is tabulated.

  23. 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 [ Time Frame: At the ARI visit (assessed from 2 weeks post first and each revaccination 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.

  24. 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 [ Time Frame: At the ARI visit (assessed from one-month post first and each revaccination 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.

  25. Duration of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes [ Time Frame: Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH) ]
    The duration of RT-PCR confirmed RSV ARI and LRTD episodes are described.

  26. Number of participants with each reported symptom/sign of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes [ Time Frame: Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH) ]
  27. Number of participants with RT-PCR confirmed RSV A and/or B ARI and LRTD episodes according to severity [ Time Frame: Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH) ]
  28. RSVPreF3 specific immunoglobulin G(IgG) antibody concentrations [ Time Frame: At Day 1 (Pre-Dose 1), Day 31, pre-season 2 (approximately 12-15 M post day 1 in NH; 13-20 M post day 1 in SH) and pre-season 3 (approximately 24-27 M post day 1 in NH; 25-32 M post day 1 in SH) ]
    The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as International Units/ milli liter (IU/mL). M in timeframe indicates month.

  29. RSV A neutralizing antibody titers [ Time Frame: At Day 1 (Pre-Dose 1), Day 31, pre-season 2 (approximately 12-15 M post day 1 in NH; 13-20 M post day 1 in SH) and pre-season 3 (approximately 24-27 M post day 1 in NH; 25-32 M post day 1 in SH) ]
    RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs)

  30. RSV B neutralizing antibody titers [ Time Frame: At Day 1 (Pre-Dose 1), Day 31, pre-season 2 (approximately 12-15 M post day 1 in NH; 13-20 M post day 1 in SH) and pre-season 3 (approximately 24-27 M post day 1 in NH; 25-32 M post day 1 in SH) ]
    RSV B neutralizing antibodies are given as GMTs.

  31. Number of participants with any, grade 3 solicited administration site events [ Time Frame: During the 4-day follow up period after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in 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.

  32. Number of participants with any, grade 3 solicited systemic events [ Time Frame: During the 4-day follow up period after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in 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).

  33. Number of days with solicited administration site and systemic events [ Time Frame: During the 4-day follow up period after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in NH) ]
  34. Number of participants with any unsolicited AEs [ Time Frame: During the 30-day follow up period after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in 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.

  35. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: 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 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.

  36. Number of participants with potential Immune Mediated Diseases (pIMDs) [ Time Frame: 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 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.

  37. Number of participants with related SAEs and fatal SAEs [ Time Frame: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for 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.

  38. Number of participants with related pIMDs [ Time Frame: From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF) (LTCF participants).
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant

  • Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
  • Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable

Exclusion Criteria:

Medical conditions

  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Serious or unstable chronic illness.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.

Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.

  • Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
  • Previous vaccination with an RSV vaccine.
  • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study vaccine or planned administration during the study period.
  • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

Other exclusions

  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  • Bedridden participants.
  • Planned move during the study period that will prohibit participating in the trial until study end. This includes:

    • Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
    • Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
  • Participation of any study personnel or their immediate dependants, family, or household members.
  • Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.

    • RSV seasons are from October to April in NH and from March to September in SH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04886596


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04886596    
Other Study ID Numbers: 212494
2020-000753-28 ( EudraCT Number )
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Respiratory syncytial virus
Lower respiratory tract disease
Efficacy study
Adults aged 60 years and above
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections