The Celljuvant study, A phase 3 Immunogenicity and Safety Study of aQIVc HD Vaccine in Adults aged 50 years and older.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Seqirus UK Limited

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

3 Nov 2023 → 16 May 2025

Decision date (initial)

2023-09-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Seqirus UK Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Prophylaxis

To demonstrate in a sequential manner:
First, clinical lot-to-lot consistency of 3 consecutive aQIVc HD lots, in terms of immunogenicity for each vaccine strain in subjects aged 50 years and older, as measured by hemagglutination inhibition (HI)* assay using cell-derived target viruses, at Day 29.
Then, immunological noninferiority of aQIVc HD vs QIVr and vs aQIV for each vaccine strain in subjects aged 50 years and older, as measured by HI* geometric mean titers (GMTs) and seroconversion rates (SCRs), using cell-derived target viruses, at Day 29.

Secondary objectives 5

1. To demonstrate immunological noninferiority of aQIVc HD vs aQIV for each vaccine strain in subjects aged 65 years and older, as measured by HI GMTs and SCRs, using cell-derived target viruses, at Day 29.
2. To compare immunogenicity of aQIVc HD vs QIVr* for each vaccine strain in subjects aged 50 years and older, in terms of superiority as measured by HI assay using cell-derived target viruses, at Day 29. *For the purpose of US licensure only, only subjects enrolled in countries where Flublok is used as a comparator will be included in this analysis.
3. To compare immunogenicity of aQIVc HD vs aQIV for each vaccine strain in subjects aged 50 years and older, in terms of superiority as measured by HI assay using cell-derived target viruses, at Day 29.
4. To compare immunogenicity of aQIVc HD vs aQIV for each vaccine strain in subjects aged 65 years and older, in terms of superiority as measured by HI assay using cell-derived target viruses, at Day 29.
5. To assess the reactogenicity from Day 1 to Day 7 and the safety from Day 1 to Day 365 of aQIVc HD, QIVr, and aQIV in subjects aged 50 years and older, overall and by age subgroup (50-64 years; 65 years and older).

Conditions and MedDRA coding

Healthy individuals or individuals with stable comorbidities which increase their risk of complications from influenza infection.

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection
2. Individuals who can comply with all study procedures

Exclusion criteria 6

1. Progressive, unstable, or uncontrolled clinical conditions
2. Known hypersensitivity or allergy to any study vaccine component
3. Known history of Guillain-Barré syndrome or other demyelinating disease
4. Condition representing a contraindication to vaccination or blood draw
5. Abnormal function of immune system due to know disorder or medication
6. Influenza vaccination within 180 days prior to informed consent or plan to receive influenza vaccine within 9 months from study vaccination (all subjects) or within 12 months (subjects in the long-term subset for immunogenicity)..

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1.Immunogenicity responses of 3 lots of aQIVc HD compared in pairs in terms of Day 29 ratio of Geometric Mean Titer (GMTr), from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. 2. Immunogenicity responses of aQIVc HD vs QIVr and aQIV in terms of: - Day 29 GMT and GMTr - Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains.

Secondary endpoints 3

1. Immunogenicity responses of aQIVc HD in comparison with aQIV vaccine in subjects aged 65 years and older in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, and Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference.
2. Immunogenicity responses of aQIVc HD, QIVr and aQIV vaccines in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup.
3. Safety of aQIVc HD, QIVr and aQIV in terms of percentage of subjects with: - Solicited Local and Systemic Reactions from Day 1 to Day 7. - Unsolicited Adverse Events from Day 1 to Day 29. - Serious Adverse Events, AEs Leading to Withdrawal, Adverse Events of Special Interest and Medically Attended Adverse Events from Day 1 to Day 365.

Investigational products

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

Test 1

Comparator 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Seqirus UK Limited

Sponsor organisation

Seqirus UK Limited

Address

The Point, 29 Market Street 29 Market Street

City

Maidenhead

Postcode

SL6 8AA

Country

United Kingdom

Scientific contact point

Organisation

Seqirus UK Limited

Contact name

Clinical Trials Disclosure

Public contact point

Organisation

Seqirus UK Limited

Contact name

Clinical Trials Disclosure

Third parties 6

Locations

3 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 23 files

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

Application history

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