Trial Outcomes & Findings for A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India (NCT NCT05648357)
NCT ID: NCT05648357
Last Updated: 2025-03-28
Results Overview
The solicited administration site adverse events included pain, redness and swelling.
COMPLETED
PHASE4
250 participants
Day 1 to Day 7
2025-03-28
Participant Flow
Participant milestones
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Overall Study
STARTED
|
250
|
|
Overall Study
COMPLETED
|
247
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Overall Study
CONSENT WITHDRAWAL, NOT DUE TO AN AE
|
3
|
Baseline Characteristics
A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
Baseline characteristics by cohort
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=250 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Age, Continuous
|
71.8 YEARS
STANDARD_DEVIATION 5.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central / South Asian Heritage
|
250 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the Solicited Safety Set (SSS), which included participants that received study intervention and had solicited safety data.
The solicited administration site adverse events included pain, redness and swelling.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=247 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Event
|
44 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: SSS population
The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=247 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
|
30 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 21Population: Analysis was performed on Exposed Set (ES) population, which included all participants that received the study intervention.
An unsolicited AE is defined as an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=250 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 21Population: ES population
A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=250 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Day 1) and Day 22Population: Analysis was performed on the Per Protocol Set (PPS), which included all participants who received the trial intervention as per protocol, had immunogenicity results pre- and post-dose, complied with the allowed dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
Serum HI antibodies against the four-influenza vaccine strains are expressed as GMTs, in titers. The assessed strains are: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=211 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
A/Victoria/4897/2022 (H1N1), Day 1
|
10.7 Titer
Interval 9.2 to 12.4
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
A/Victoria/4897/2022 (H1N1), Day 22
|
187.9 Titer
Interval 150.2 to 235.1
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
A/Darwin/9/2021 (H3N2), Day 1
|
20.2 Titer
Interval 17.0 to 23.9
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
A/Darwin/9/2021 (H3N2), Day 22
|
205.3 Titer
Interval 169.5 to 248.8
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
B/Austria/1359417/2021, Day 1
|
100.8 Titer
Interval 87.8 to 115.9
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
B/Austria/1359417/2021, Day 22
|
903.6 Titer
Interval 780.4 to 1046.3
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
B/Phuket/3073/2013, Day 1
|
93.3 Titer
Interval 82.0 to 106.2
|
|
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
B/Phuket/3073/2013, Day 22
|
701.6 Titer
Interval 611.7 to 804.7
|
SECONDARY outcome
Timeframe: At Day 22 (compared with Baseline [Day 1])Population: PPS population
MGI is defined as the fold increase in post-vaccination serum HI GMTs compared with Baseline. Analysis was performed for four influenza strains: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=211 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Mean Geometric Increase (MGI) of Serum HI Antibodies
A/Victoria/4897/2022 (H1N1)
|
17.6 Fold increase
Interval 13.6 to 22.9
|
|
Mean Geometric Increase (MGI) of Serum HI Antibodies
A/Darwin/9/2021 (H3N2)
|
10.2 Fold increase
Interval 8.2 to 12.7
|
|
Mean Geometric Increase (MGI) of Serum HI Antibodies
B/Austria/1359417/2021
|
9.0 Fold increase
Interval 7.5 to 10.7
|
|
Mean Geometric Increase (MGI) of Serum HI Antibodies
B/Phuket/3073/2013
|
7.5 Fold increase
Interval 6.4 to 8.9
|
SECONDARY outcome
Timeframe: At Day 22Population: PPS population
SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (\<) 1:10 and a postvaccination titer greater than or equal to (\>=) 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=211 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Number of Participants With Seroconversion Rate (SCR)
A/Victoria/4897/2022 (H1N1)
|
169 Participants
|
|
Number of Participants With Seroconversion Rate (SCR)
A/Darwin/9/2021 (H3N2)
|
160 Participants
|
|
Number of Participants With Seroconversion Rate (SCR)
B/Austria/1359417/2021
|
173 Participants
|
|
Number of Participants With Seroconversion Rate (SCR)
B/Phuket/3073/2013
|
162 Participants
|
SECONDARY outcome
Timeframe: At Day 1 and Day 22Population: PPS population
SPR is defined as the percentage of participants with a serum HI titer \>=1:40.
Outcome measures
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=211 Participants
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
Number of Participants With Seroprotection Rate (SPR)
A/Victoria/4897/2022 (H1N1), Day 1
|
40 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
A/Victoria/4897/2022 (H1N1), Day 22
|
180 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
A/Darwin/9/2021 (H3N2), Day 1
|
69 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
A/Darwin/9/2021 (H3N2), Day 22
|
187 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
B/Austria/1359417/2021, Day 1
|
182 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
B/Austria/1359417/2021, Day 22
|
209 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
B/Phuket/3073/2013, Day 1
|
186 Participants
|
|
Number of Participants With Seroprotection Rate (SPR)
B/Phuket/3073/2013, Day 22
|
210 Participants
|
Adverse Events
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group
n=250 participants at risk
Participants received 1 dose of seasonal FLU vaccine at Day 1.
|
|---|---|
|
General disorders
Administration site erythema
|
2.0%
5/250 • Number of events 5 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
General disorders
Administration site pain
|
14.8%
37/250 • Number of events 37 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
General disorders
Administration site swelling
|
1.6%
4/250 • Number of events 4 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
General disorders
Fatigue
|
0.40%
1/250 • Number of events 1 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
General disorders
Pyrexia
|
6.4%
16/250 • Number of events 16 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.40%
1/250 • Number of events 1 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
Infections and infestations
Pustule
|
0.40%
1/250 • Number of events 1 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
4/250 • Number of events 4 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
8/250 • Number of events 9 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
|
Nervous system disorders
Headache
|
2.0%
5/250 • Number of events 5 • Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER