Trial Outcomes & Findings for Immunogenicity of COVID-19 Vaccine Co-administration With Influenza Vaccine in Healthy Volunteers (NCT NCT06831786)

NCT ID: NCT06831786

Last Updated: 2025-12-04

Results Overview

IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: Before vaccination
• Results posted on: 2025-12-04

Participant Flow

Volunteers were recruited between March and April 2024 at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.

A total of 42 adults were screened for eligibility. Six were excluded because of uncontrolled chronic diseases, leaving 36 participants who were randomized.

Participant milestones

Measure	COVID-19 vaccine Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza vaccine Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	12	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	COVID-19 Vaccine n=12 Participants Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza Vaccine n=12 Participants Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration n=12 Participants Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Total n=36 Participants Total of all reporting groups
Age, Continuous	28 year n=12 Participants	39 year n=12 Participants	29 year n=12 Participants	31 year n=36 Participants
Sex: Female, Male Female	10 Participants n=12 Participants	8 Participants n=12 Participants	8 Participants n=12 Participants	26 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=12 Participants	4 Participants n=12 Participants	4 Participants n=12 Participants	10 Participants n=36 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Duration from last COVID-19 vaccination	90 week n=12 Participants	85.5 week n=12 Participants	85.5 week n=12 Participants	87.5 week n=36 Participants

PRIMARY outcome

Timeframe: Before vaccination

IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay

Outcome measures

Measure	COVID-19 vaccine n=12 Participants Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza vaccine n=12 Participants Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration n=12 Participants Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline	19.6 SFCs/10⁶ PBMCs Interval 8.8 to 43.9	14 SFCs/10⁶ PBMCs Interval 4.6 to 42.7	12.6 SFCs/10⁶ PBMCs Interval 6.5 to 24.7

PRIMARY outcome

Timeframe: 4 weeks post vaccination

IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay

Outcome measures

Measure	COVID-19 vaccine n=12 Participants Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza vaccine n=12 Participants Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration n=12 Participants Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks	59.9 SFCs/10⁶ PBMCs Interval 26.2 to 136.9	15.2 SFCs/10⁶ PBMCs Interval 4.5 to 51.0	61.6 SFCs/10⁶ PBMCs Interval 37.1 to 102.2

PRIMARY outcome

Timeframe: before vaccination

IgG response against the SARS-CoV-2 virus, measured by ELISA.

Outcome measures

Measure	COVID-19 vaccine n=12 Participants Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza vaccine n=12 Participants Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration n=12 Participants Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline	1276.3 BAU/mL Interval 933.9 to 1744.1	1074.2 BAU/mL Interval 574.3 to 2009.3	1299.7 BAU/mL Interval 729.7 to 2314.8

PRIMARY outcome

Timeframe: 4 weeks post vaccination

IgG response against the SARS-CoV-2 virus, measured by ELISA.

Outcome measures

Measure	COVID-19 vaccine n=12 Participants Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza vaccine n=12 Participants Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration n=12 Participants Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks	10456.1 BAU/mL Interval 7688.6 to 14219.7	1008.0 BAU/mL Interval 568.9 to 1786.2	8558.7 BAU/mL Interval 5666.6 to 12926.9

Adverse Events

COVID-19 vaccine

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Influenza vaccine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Co-administration

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	COVID-19 vaccine n=12 participants at risk Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Influenza vaccine n=12 participants at risk Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination	Co-administration n=12 participants at risk Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
Musculoskeletal and connective tissue disorders mass at injection site	25.0% 3/12 • Number of events 3 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Musculoskeletal and connective tissue disorders Myalgia	58.3% 7/12 • Number of events 7 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	75.0% 9/12 • Number of events 9 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Musculoskeletal and connective tissue disorders Malaise	41.7% 5/12 • Number of events 5 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	8.3% 1/12 • Number of events 1 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	41.7% 5/12 • Number of events 5 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Nervous system disorders headache	16.7% 2/12 • Number of events 2 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	33.3% 4/12 • Number of events 4 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Immune system disorders fever	8.3% 1/12 • Number of events 1 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	16.7% 2/12 • Number of events 2 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Respiratory, thoracic and mediastinal disorders dyspnea	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	8.3% 1/12 • Number of events 1 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Gastrointestinal disorders nausea	8.3% 1/12 • Number of events 1 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Musculoskeletal and connective tissue disorders Redness at injection site	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	16.7% 2/12 • Number of events 2 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	8.3% 1/12 • Number of events 1 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Musculoskeletal and connective tissue disorders pain at injection site	83.3% 10/12 • Number of events 10 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	75.0% 9/12 • Number of events 9 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	83.3% 10/12 • Number of events 10 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
Musculoskeletal and connective tissue disorders swelling at injection site	25.0% 3/12 • Number of events 3 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	0.00% 0/12 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.	8.3% 1/12 • Number of events 1 • From vaccination until 28 days post vaccination Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.

Additional Information

Sarunyou Chusri

prince of songkla university

Phone: +66897340446

Email: sarunyouchusri@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place