CompletedPhase 1

Study of Gamma PN3 in the Elderly

Australia105 participantsStarted 2024-08-26

Plain-language summary

Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly

Age range70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female volunteers aged 70 years and over at Screening.
✓. In stable good general health as determined by the outcome of medical history, physical examination, and clinical judgement by the Investigator. Chronic stable non-inflammatory conditions such as hypertension, hyperlipidemia, well-controlled type 2 diabetes, stable asthma, controlled psychiatric conditions such as anxiety or depression, stable ischemic heart disease with heart failure not greater than NYHA Grade 1 and 2 are permitted, as determined by the Investigator.
✓. Willing and able to give voluntary written informed consent before screening assessments commence.
✓. Vital signs within the following ranges (inclusive):
✓. 12-lead ECG parameters within the following ranges:
✓. Willing and able to communicate with the Investigator and study team and understands the requirements of the study.
✓. Willing and able to undertake the study visits and all assessments, including possessing a suitable device and access to the internet for using the web-based electronic diary (e.g., smartphone, tablet, or computer) and able to use the device for this purpose.
✓. Vaccinated against severe acute respiratory syndrome corona virus 2 (SARS-CoV-2; COVID-19) with a minimum of a prime and boost vaccinations.

Adverse events

Timeframe: 57 days

Geometric fold increase in IgG titre

Timeframe: 56 days

NCT IDNCT06562790

SponsorGPN Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-31

Who can participate

Age range70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female volunteers aged 70 years and over at Screening.
✓. In stable good general health as determined by the outcome of medical history, physical examination, and clinical judgement by the Investigator. Chronic stable non-inflammatory conditions such as hypertension, hyperlipidemia, well-controlled type 2 diabetes, stable asthma, controlled psychiatric conditions such as anxiety or depression, stable ischemic heart disease with heart failure not greater than NYHA Grade 1 and 2 are permitted, as determined by the Investigator.
✓. Willing and able to give voluntary written informed consent before screening assessments commence.
✓. Vital signs within the following ranges (inclusive):
✓. 12-lead ECG parameters within the following ranges:
✓. Willing and able to communicate with the Investigator and study team and understands the requirements of the study.
✓. Willing and able to undertake the study visits and all assessments, including possessing a suitable device and access to the internet for using the web-based electronic diary (e.g., smartphone, tablet, or computer) and able to use the device for this purpose.
✓. Vaccinated against severe acute respiratory syndrome corona virus 2 (SARS-CoV-2; COVID-19) with a minimum of a prime and boost vaccinations.