Last updated: 07/02/2026 04:30:09
A Prospective Non-Interventional Study to Compare Heterologous and Homologous Humoral Immune Responses in Serum Samples from Q-Pan-002 and Q-Pan-H5N8-001 Studies
GSK study ID
308921
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: FLU Q-PAN H5N8=AS03-003 A Prospective Non-Interventional Study to Compare Heterologous and Homologous Humoral Immune Responses in Serum Samples from Q-Pan-002 and Q-Pan-H5N8-001 Studies
Trial description: The purpose of the study is to test the superiority of the humoral immune response of serum from the FLU Q-Pan H5N8 study over that of serum from the Q-Pan H5N1 study against A/Astrakhan/3212/2020-like (H5N8) virus. The serum samples from the FLU Q-Pan H5N8 study will once again be tested against this H5N8 virus. The suitability of the >10 years old samples from the FLU Q-Pan H5N1 study will be assessed by comparing the responses generated by a newly developed and validated assay against the original BLA strain A/Indonesia/05/2005 (H5N1) to the original responses shown in the FLU Q-Pan H5N1 study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Humoral immune (HI) titers expressed as Geometric Meant Titers (GMT) for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine over the H5N1 vaccine
Timeframe: At Day 43
Secondary outcomes:
HI titers expressed as GMT for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: At Day 1
HI titers increase expressed as geometric mean fold rise (GMFR) for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: From Day 1 to Day 43
HI seroprotection (SP) expressed as HI titer >=1:40 for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: At Day 1 and Day 43
HI seroconversion (SC) expressed as seroconversion rate (SCR) for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: From Day 1 to Day 43
Percentage of participants that received H5N8 and H5N1 vaccines with A/Astrakhan/3212/2020-like (H5N8) virus and are seropositive (HI seropositivity)
Timeframe: At Day 1 and Day 43
Microneutralization (MN) titers expressed as GMT for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: At Day 1 and Day 43
MN titers increase expressed as GMFR for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: From Day 1 to Day 43
MN vaccine response (VR) expressed as vaccine response rate (VRR) for A/Astrakhan/3212/2020-like (H5N8) virus of the H5N8 vaccine and the H5N1 vaccine
Timeframe: From Day 1 to Day 43
Percentage of participants that received H5N8 and H5N1 vaccines with A/Astrakhan/3212/2020-like (H5N8) virus and are seropositive (MN seropositivity)
Timeframe: At Day 1 and Day 43
HI titers expressed as GMT for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: At Day 1 and Day 43
HI titers increase expressed as GMFR for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: From Day 1 to Day 43
HI SP expressed as HI titer >=1:40 for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: At Day 1 and Day 43
HI SC expressed as SCR for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: Day 1 to Day 43 compared with pre-vaccination
Percentage of participants that received H5N8 and H5N1 vaccines with A/Indonesia/5/2005 (H5N1) virus and are seropositive (HI seropositivity)
Timeframe: At Day 1 and Day 43
MN titers expressed as GMT for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: At Day 1 and Day 43
MN titers increase expressed as GMFR for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: From Day 1 to Day 43
MN VR expressed as VRR for A/Indonesia/5/2005 (H5N1) virus of the H5N8 vaccine and of the H5N1 vaccine
Timeframe: From Day 1 to Day 43
Percentage of participants that received H5N8 and H5N1 vaccines with A/Indonesia/5/2005 (H5N1) virus and are seropositive (MN seropositivity)
Timeframe: At Day 1 and Day 43
Interventions:
Not applicable
Enrollment:
257
Observational study model:
Cohort
Primary completion date:
2026-30-07
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Influenza, Human
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2026 to July 2026
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Inclusion criteria from contributing studies, including:
- 1. Written consent.
- Exclusion criteria from contributing studies, including:
- 1. Immunosuppressive condition in medical history or current conditions (including HIV).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria from contributing studies, including: 1. Written consent. 2. Male or non-pregnant female. 3. Age 18 years of age and above. 4. Generally healthy and/or stable medical conditions. Inclusion criteria for this study: 1. Participants have provided consent to the use of their serum samples for further research related to their original study. 2. Participants received H5N8 or H5N1 vaccine containing 3.75 or 3.8 micrograms (μg) HA respectively adjuvanted with AS03A. 3. Participants were included in the Per Protocol Set for the primary immunogenicity endpoint in their original study. 4. Participants in the Q-Pan H5N1 study must match the population of the selected group of participants from the Q-Pan H5N8 study, based on Sex, Race, Ethnicity and Age.
Exclusion criteria:
- Exclusion criteria from contributing studies, including: 1. Immunosuppressive condition in medical history or current conditions (including HIV). 2. Immunosuppressive medication. 3. Cancer diagnosis and/or treatment within the previous 3 years (some exceptions). 4. Substance abuse. 5. Known hypersensitivity to vaccine components. 6. Participation in another concurrent study of an investigational product. Exclusion criteria for this study: NA
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website