2025-522698-13-00RecruitingPhase 4
Evaluation of Influenza Vaccine Immune Response in Obesity (VaccObFlu)
Phase IV open-label clinical trial of the immunogenicity and safety of standard dose trivalent inactivated influenza vaccine (Influvac) in a population of people with obesity
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Jul 2026
Brief summary (registry, in English)
To describe changes in Hemagglutination Inhibition Assay (HAI) geometric mean titre (GMT) after Influvac, 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 16 Oct 2025
- Start date
- 5 Oct 2026
- Lead sponsor
- Region Stockholm – SLSO
- Diseases
- Obesity, Type 2 diabetes
- EU CT number
- 2025-522698-13-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented receipt of influenza vaccine in the current season September-April.
- 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.
- Antibiotic use in the previous 12 weeks.
- Pregnancy prior to week 12.
- Confirmed anaphylaxis after exposure to egg or after previous influenza vaccination.
- Disease, condition or concomitant medication known to cause immunosuppression.
Other illness
- Any other pre-existing disease or medical condition judged by the trial investigator as being a contra-indication for study participation.
- Confirmed influenza infection during the current season September-April.
- 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.
- Allergy to Influvac.
- 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).
Other
- Receipt of blood transfusion within the preceding 6 months.
- Participation in another clinical trial during the study period.
- Planned move during the study period that would prohibit participating in the study for its full duration.
- 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.
- Receipt of Immunoglobulin within the preceding 6 months.
Who the study is looking for
- The subject is able to give their written consent to participate in the trial.
- For female subjects of fertile age, adequate contraception should be used (Groups 1, 2 and 3).
- Obesity as defined by BMI ≥30kg/m2 (Group 1 and Group 4 and Group 6)
- Aged 18-50 years at inclusion
- A diagnosis of diabetes mellitus type 2 (Groups 2 and Group 6)
- For groups 2, 3 and group 5 non-obese as defined by BMI 18.5-29.9kg/m2
- Pregnant after week 12 (Groups 4 and 5)
- Use of GLP-1 analogue (Group 6 only)
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Stockholm – SLSO | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.