Evaluation of Influenza Vaccine Immune Response in Obesity (VaccObFlu)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Stockholm – SLSO

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2025-12-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Region Stockholm

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To describe changes in Hemagglutination Inhibition Assay (HAI) geometric mean titre (GMT) after Vaxigrip, including the proportions of participants achieving a protective titre ≥40 and the proportion of participants achieving a 4-fold rise in titre at 14 days post vaccine.

Secondary objectives 2

1. To evaluate the safety of Vaxigrip in terms of reported solicited and unsolicited local and systemic adverse events (AEs) in the 7 days after vaccination.
2. The evaluate the safety of Vaxigrip in terms of the incidence of serious adverse events (SAEs).

Conditions and MedDRA coding

Influenza, Obesity, Type 2 diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1) The subject is able to give their written consent to participate in the trial.
2. 2) For female subjects of fertile age, adequate contraception should be used (Groups 1, 2 and 3).
3. 3) Obesity as defined by BMI ≥30kg/m2 (Group 1 and Group 4)
4. 4) Aged 18-50 years at inclusion
5. 5) A diagnosis of diabetes mellitus type 2, or no diagnosis of diabetes mellitus (Groups 2 and 3)
6. 6) For group 2 and group 5 non-obese as defined by BMI 18.5-29.9kg/m2 and for group 3 normal body weight as defined by BMI 18.5-24.9kg/m2
7. 7) Pregnant after week 12 (Groups 4 and 5)

Exclusion criteria 16

1. Documented receipt of influenza vaccine in the current season September-April.
2. Receipt of Immunoglobulin within the preceding 6 months.
3. Receipt of blood transfusion within the preceding 6 months.
4. Receipt of another vaccine less than 14 days prior to study vaccination in the case of inactivated vaccines or 30 days in the case of live vaccines.
5. Participation in another clinical trial during the study period.
6. Planned move during the study period that would prohibit participating in the study for its full duration.
7. Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to the sponsor or the PI.
8. Any other pre-existing disease or medical condition judged by the trial investigator as being a contra-indication for study participation.
9. Antibiotic use in the previous 12 weeks.
10. Confirmed influenza infection during the current season September-April.
11. Pregnancy prior to week 12.
12. Unable to give informed consent due to either language barrier or condition affecting the ability of the potential participant to understand, retain or communicate their consent as judged by the study investigator.
13. Allergy to Vaxigrip.
14. Confirmed anaphylaxis after exposure to egg or after previous influenza vaccination.
15. Disease, condition or concomitant medication known to cause immunosuppression.
16. Current or previous malignancy within the past 5 years (with the exception of CIN I or II cervical pre-cancerous lesions, or skin cancers in situ).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Hemaglutinnin Inhibition Assay GMTs at day 0 (pre-vaccination) and at 14 days post-vaccination with Vaxigrip.
2. The proportion of participants achieving a protective hemagluttinin inhibition assay titre ≥40 at 14 days post-vaccination.
3. The proportion of participants achieving a four-fold rise in hemagluttinin inhibition assay titre at 14 days post-vaccination.

Secondary endpoints 2

1. Incidence of solicited local (injection site) and systemic AEs in the 7-days post-vaccination.
2. Incidence of SAEs, unsolicited AEs and fatal AEs during the period of the study.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Stockholm – SLSO

Sponsor organisation

Region Stockholm – SLSO

Address

Solnavagen 1 E, S:t Matteus S:t Matteus

City

Stockholm

Postcode

113 65

Country

Sweden

Scientific contact point

Organisation

Region Stockholm – SLSO

Contact name

Catherine Isitt

Public contact point

Organisation

Region Stockholm – SLSO

Contact name

Catherine Isitt

Locations

1 EU/EEA country · 1 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 11 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