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Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older
The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV. The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.
Study details:
Study duration per participant:. 6 months. Treatment Duration:.
1 IM injection. Participants will be followed for approximately 6 months post- vaccination.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 60 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-02
Primary completion: 2025-02-18
Study completion finish: 2025-02-18
Study type
PREVENTION
Phase
PHASE2
Trial ID
NCT06251024
Intervention or treatment
BIOLOGICAL: RSV vaccine candidate
BIOLOGICAL: Placebo
Conditions
- • Healthy Volunteers
- • Respiratory Syncytial Virus Infection
Find a site
Closest Location:
Investigational Site Number : 0360003
Research sites nearby
Select from list below to view details:
Investigational Site Number : 0360003
Botany, New South Wales, Australia
Investigational Site Number : 0360004
Sippy Downs, Queensland, Australia
Investigational Site Number : 0360001
Southport, Queensland, Australia
Investigational Site Number : 0360002
Camberwell, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Group 1: RSV vaccine candidate
| BIOLOGICAL: RSV vaccine candidate
|
PLACEBO_COMPARATOR: Group 2: placebo
| BIOLOGICAL: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination | Number of participants experiencing RSV-LRTD (RSV A and/or RSV B) ≥ 14 days after vaccination | ≥ 14 days after vaccination |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination | Number of participants experiencing RSV-ARD (RSV A and/or RSV B) ≥ 14 days after vaccination | ≥ 14 days after vaccination |
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination | Number of participants experiencing RSV-MAARD (RSV A and/or RSV B) ≥ 14 days after vaccination | ≥ 14 days after vaccination |
Presence of the first episode of RSV LRTD (RSV A) occurring ≥ 14 days after vaccination) | Number of participants experiencing RSV-LRTD (RSV A) ≥ 14 days after vaccination | ≥ 14 days after vaccination |
Presence of the first episode of RSV LRTD (RSV B) occurring ≥ 14 days after vaccination | Number of participants experiencing RSV-LRTD (RSV B) ≥ 14 days after vaccination | ≥ 14 days after vaccination |
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group | Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by age group | ≥ 14 days after vaccination |
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities | Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline comorbidities | ≥ 14 days after vaccination |
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status | Number of participants experiencing RSV-LRTD (RSV A and/or B and by each one) by baseline frailty status | ≥ 14 days after vaccination |
Presence of hospitalization due to RSV-ARD and/or RSV-LRTD | Number of participants hospitalized due to RSV-ARD and/or RSV-LRTD | ≥ 14 days after vaccination |
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B) | Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B) | ≥ 14 days after vaccination |
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B) | Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B) | ≥ 14 days after vaccination |
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring ≥ 14 days after vaccination | Number of participants experiencing severe RSV-LRTD (RSV A and/or B and by each one) | ≥ 14 days after vaccination |
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset | RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset | Day 1 and Day 29 |
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset | RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset | Day 1 and Day 29 |
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset | Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset | Day 1 and Day 29 |
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset | RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset | Month 6 |
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset | RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset | Month 6 |
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset | Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset | Month 6 |
Presence of solicited injection site or systemic reactions | Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills | Within 7 days after primary vaccination |
Presence of unsolicited immediate systemic adverse events (AEs) | Number of participants experiencing an unsolicited immediate systemic adverse event | Within 30 minutes after primary vaccination |
Presence of unsolicited AEs | Number of participants experiencing unsolicited AEs | Within 28 days after primary vaccination |
Presence of serious adverse events (SAEs) | Number of participants experiencing SAEs | Throughout study (approximately 6 months) |
Presence of medically attended adverse events (MAAEs) | Number of participants experiencing MAAEs | Throughout study (approximately 6 months) |
Presence of adverse events of special interest (AESIs) | Number of participants experiencing AESIs | Throughout study (approximately 6 months) |
Frequently Asked Questions
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