A study to evaluate the efficacy, immunogenicity, and safety of an RSV and hMPV VLP vaccine compared with placebo in participants aged 60 years of age and older

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB, Icosavax Inc.

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2024-11-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others

To demonstrate the efficacy of a single IM vaccination with IVX-A12 in preventing confirmed RSV LRTD and hMPV LRTD (any severity) in adults ≥ 60 years old during the first season compared to placebo

Secondary objectives 2

1. To demonstrate the efficacy of IVX-A12 in preventing confirmed RSV LRTD and hMPV LRTD in adults ≥ 60 years old over two seasons compared to placebo
2. To demonstrate the efficacy of IVX-A12 in preventing confirmed RSV severe LRTD and hMPV severe LRTD in adults ≥ 60 years old over two seasons compared to placebo

Conditions and MedDRA coding

Respiratory Syncytial Virus and Human Metapneumovirus

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participant ≥ 60 years of age at the time of signing the informed consent.
2. Participants who are medically stable in the opinion of the Investigator at the time of study intervention. 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.
3. Able to understand and comply with study requirements/procedures including attending all scheduled study visits (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined) based on the assessment of the Investigator.

Exclusion criteria 4

1. Receipt of any licensed or investigational RSV and/or hMPV vaccine within the past 6 months prior to administration of study intervention, or planned receipt during the study.
2. History of a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder) contraindicating IM injections or venipuncture based on Investigator judgement.
3. History of hypersensitivity to any component of the study intervention.
4. History of severe AR associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Occurrence of the first RSV-confirmed LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 during the first season
2. Occurrence of the first hMPV-confirmed LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 during the first season

Secondary endpoints 4

1. Occurrence of the first RSV-confirmed LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 over two seasons
2. Occurrence of the first hMPV-confirmed LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 over two seasons
3. Occurrence of the first RSV-confirmed severe LRTD (confirmed RSV A and/or B associated LRTD) starting on Day 15 over two seasons
4. Occurrence of the first hMPV-confirmed severe LRTD (confirmed hMPV A and/or B associated LRTD) starting on Day 15 over two seasons

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

Clinical Study Information Center

Third parties 10

Icosavax Inc.

Sponsor organisation

Icosavax Inc.

Address

1930 Boren Avenue Suite 1000

City

Seattle

Postcode

98101-1406

Country

United States

Sponsor responsibilities

Article 77 compliance

AstraZeneca AB

Contact point sponsor

AstraZeneca AB

Article 77 implementation

AstraZeneca AB

Locations

8 EU/EEA countries · 79 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 150 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications