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Cancer Vaccine

Vaccine for Respiratory Syncytial Virus

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants of non-childbearing potential

Male or female participant 18-49 YOA at the time of the study intervention administration

Must not have

History of dementia or any medical condition that moderately or severely impairs cognition

Medical condition that would make intramuscular injection unsafe

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration compared to baseline (day 1)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test a new vaccine for respiratory syncytial virus in adults aged 18-49 years who are at risk for the disease, compared to older adults aged 60 years and above

Who is the study for?

This trial is for non-immunocompromised adults aged 18-49 at increased risk for RSV disease, and older adults aged 60+. Key eligibility details are not provided, so interested individuals should contact the study organizers for full inclusion and exclusion criteria.

What is being tested?

The study tests the immune response and safety of an investigational vaccine called RSVPreF3 OA. It compares how younger adults (18-49) at higher risk respond to the vaccine versus those who are older (60+).

What are the potential side effects?

Specific side effects aren't listed here, but typically vaccines may cause reactions like soreness at injection site, fever, fatigue or mild flu-like symptoms. Participants will be monitored for any adverse responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot become pregnant.

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I am between 18 and 49 years old.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that significantly affects my thinking or memory.

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I have a condition that makes getting shots in my muscles unsafe.

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I have been vaccinated against RSV before.

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I am not on long-term immune-modifying drugs.

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I have a condition that weakens my immune system.

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I have recurring or uncontrolled seizures or neurological disorders.

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I have received or plan to receive a vaccine not listed in the study guidelines.

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I am bedridden.

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I am not planning to become pregnant or stop using birth control within a month after the study treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs) (RSV-OA over RSV-A-AIR)

Part A: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR)

Part A: SRR in RSV-B neutralizing titers

+1 more

Secondary study objectives

Part A and B: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF)

Part A and B: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs

Part A and B: Percentage of participants reporting solicited administration site events

+4 more

Side effects data

From 2022 Phase 3 trial • 976 Patients • NCT04841577

53%

Injection site pain

23%

Fatigue

22%

Headache

22%

Myalgia

17%

Arthralgia

Injection site erythema

Injection site swelling

Pyrexia

Cough

Epistaxis

Death

Injection site bruising

Back pain

Upper respiratory tract infection

Oropharyngeal pain

Nausea

Pain

Neck pain

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Co-Ad Group

Control Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: RSV-A-AIR GroupExperimental Treatment1 Intervention

Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).

Group II: Part A: RSV-OA GroupExperimental Treatment1 Intervention

Older adults (OA) participants, \>=60 YOA, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).

Group III: Part A: RSV-A-AIR GroupExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVPreF3 OA investigational vaccine

2023

Completed Phase 3

~5970

0 / 12Eligibility criteria met