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NCT05559476

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

Completed Phase 3 Results posted Last updated 24 September 2024
What this trial tests

Phase 3 trial testing RSVPreF3 OA investigational vaccine in Respiratory Syncytial Virus Infections in 1,029 participants. Completed in 15 August 2023.

Timeline
20 October 2022
Primary endpoint
7 March 2023
15 August 2023

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,029
Start date20 October 2022
Primary completion7 March 2023
Estimated completion15 August 2023
Sites46 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

65 and older, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs) Primary · At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)

RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).

GroupValue95% CI
Co-Ad Group5876.35299.5 – 6515.9
Control Group6935.36200.0 – 7757.9
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs Primary · At 1 month after the FLU vaccine dose (Day 31 for both groups)

HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.

Flu A/Darwin/6/2021 H3N2
GroupValue95% CI
Co-Ad Group72.764.1 – 82.5
Control Group72.363.7 – 82.1
Flu A/Victoria/2570/2019 H1N1
GroupValue95% CI
Co-Ad Group189.9167.6 – 215.1
Control Group177.3156.4 – 200.9
Flu B/Austria/1359417/2021 Victoria
GroupValue95% CI
Co-Ad Group859.8805.8 – 917.5
Control Group820.9768.8 – 876.6
Flu B/Phuket/3073/2013 Yamagata
GroupValue95% CI
Co-Ad Group758.7699.1 – 823.4
Control Group703.4647.7 – 763.9
RSV-B Neutralizing Titers Expressed as Group GMTs Primary · At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)

RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).

GroupValue95% CI
Co-Ad Group8251.57460.6 – 9126.3
Control Group8359.07492.8 – 9325.3
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains Secondary · At 1 month after the FLU vaccine dose (Day 31 for both groups)

SCR for HI titers was defined as the percentage of participants who have either a HI predose titer less than (\<) 1:10 and a post-dose titer greater than or equal to (\>=) 1:40, or a pre-dose titer \>= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.

Flu A/Darwin/6/2021 H3N2
GroupValue95% CI
Co-Ad Group59.254.5 – 63.8
Control Group57.552.7 – 62.2
Flu A/Victoria/2570/2019 H1N1
GroupValue95% CI
Co-Ad Group50.946.2 – 55.6
Control Group46.842.0 – 51.6
Flu B/Austria/1359417/2021 Victoria
GroupValue95% CI
Co-Ad Group39.735.2 – 44.3
Control Group31.126.8 – 35.7
Flu B/Phuket/3073/2013 Yamagata
GroupValue95% CI
Co-Ad Group43.639.0 – 48.3
Control Group37.733.2 – 42.4
RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI) Secondary · At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)

MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.

GroupValue95% CI
Co-Ad Group5.595.02 – 6.23
Control Group6.755.93 – 7.68
RSV-B Neutralizing Titers Expressed as MGI Secondary · At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)

MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.

GroupValue95% CI
Co-Ad Group5.194.69 – 5.75
Control Group5.294.65 – 6.03
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT Secondary · At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)

HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains. HI antibodies were expressed as GMTs, in titers.

Flu A/Darwin/6/2021 H3N2, Day 1
GroupValue95% CI
Co-Ad Group11.510.5 – 12.7
Control Group12.611.4 – 14.0
Flu A/Darwin/6/2021 H3N2, Day 31
GroupValue95% CI
Co-Ad Group71.863.6 – 81.0
Control Group75.166.7 – 84.4
Flu A/Victoria/2570/2019 H1N1, Day 1
GroupValue95% CI
Co-Ad Group35.331.2 – 40.1
Control Group41.936.9 – 47.6
Flu A/Victoria/2570/2019 H1N1, Day 31
GroupValue95% CI
Co-Ad Group200.0178.7 – 223.8
Control Group194.7173.9 – 217.9
Flu B/Austria/1359417/2021 Victoria, Day 1
GroupValue95% CI
Co-Ad Group292.6270.6 – 316.4
Control Group308.5285.8 – 333.1
Flu B/Austria/1359417/2021 Victoria, Day 31
GroupValue95% CI
Co-Ad Group848.0799.7 – 899.2
Control Group818.3769.2 – 870.5
Flu B/Phuket/3073/2013 Yamagata, Day 1
GroupValue95% CI
Co-Ad Group239.2220.6 – 259.3
Control Group245.5226.1 – 266.5
Flu B/Phuket/3073/2013 Yamagata, Day 31
GroupValue95% CI
Co-Ad Group751.1698.9 – 807.2
Control Group699.6646.9 – 756.6
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains Secondary · At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)

SPR for HI titers was defined as the percentage of participants with a serum HI titer \>= 1:40. The assessed Flu strains were: The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.

Flu A/Darwin/6/2021 H3N2, Day 1
GroupValue95% CI
Co-Ad Group17.914.7 – 21.6
Control Group21.918.3 – 25.7
Flu A/Darwin/6/2021 H3N2, Day 31
GroupValue95% CI
Co-Ad Group75.371.1 – 79.2
Control Group76.672.3 – 80.5
Flu A/Victoria/2570/2019 H1N1, Day 1
GroupValue95% CI
Co-Ad Group53.448.9 – 57.8
Control Group61.056.6 – 65.3
Flu A/Victoria/2570/2019 H1N1, Day 31
GroupValue95% CI
Co-Ad Group92.389.5 – 94.6
Control Group94.592.0 – 96.5
Flu B/Austria/1359417/2021 Victoria, Day 1
GroupValue95% CI
Co-Ad Group98.897.4 – 99.6
Control Group99.698.6 – 100.0
Flu B/Austria/1359417/2021 Victoria, Day 31
GroupValue95% CI
Co-Ad Group10099.2 – 100
Control Group10099.2 – 100
Flu B/Phuket/3073/2013 Yamagata, Day 1
GroupValue95% CI
Co-Ad Group96.894.9 – 98.2
Control Group98.296.6 – 99.2
Flu B/Phuket/3073/2013 Yamagata, Day 31
GroupValue95% CI
Co-Ad Group10099.2 – 100
Control Group10099.2 – 100
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI Secondary · At 1 month after the FLU vaccine dose administration (Day 31 for both groups)

MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.

Flu A/Darwin/6/2021 H3N2
GroupValue95% CI
Co-Ad Group6.205.49 – 7.00
Control Group5.875.20 – 6.62
Flu A/Victoria/2570/2019 H1N1
GroupValue95% CI
Co-Ad Group5.574.81 – 6.46
Control Group4.533.94 – 5.21
Flu B/Austria/1359417/2021 Victoria
GroupValue95% CI
Co-Ad Group2.922.69 – 3.18
Control Group2.712.51 – 2.93
Flu B/Phuket/3073/2013 Yamagata
GroupValue95% CI
Co-Ad Group3.132.85 – 3.44
Control Group2.872.62 – 3.14
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration Secondary · Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)

The solicited administration site events after vaccination included erythema, pain and swelling.

Erythema, Flu administration at Day 1
GroupValue95% CI
Co-Ad Group4.02.4 – 6.4
Control Group4.62.8 – 7.1
Erythema, RSV administration at Day 1
GroupValue95% CI
Co-Ad Group4.32.5 – 6.6
Erythema, RSV administration at Day 31
GroupValue95% CI
Control Group4.32.5 – 6.7
Pain, Flu administration at Day 1
GroupValue95% CI
Co-Ad Group47.042.2 – 51.9
Control Group43.537.7 – 47.4
Pain, RSV administration at Day 1
GroupValue95% CI
Co-Ad Group55.650.7 – 60.4
Pain, RSV administration at Day 31
GroupValue95% CI
Control Group45.840.8 – 50.8
Swelling, Flu administration at Day 1
GroupValue95% CI
Co-Ad Group4.52.7 – 6.9
Control Group5.63.6 – 8.2
Swelling, RSV administration at Day 1
GroupValue95% CI
Co-Ad Group4.02.4 – 6.4
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration Secondary · Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)

The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia.

Arthralgia, Dosing at Day 1
GroupValue95% CI
Co-Ad Group16.112.7 – 19.9
Control Group13.810.6 – 15.5
Arthralgia, Dosing at Day 31
GroupValue95% CI
Control Group13.09.9 – 16.7
Fatigue, Dosing at Day 1
GroupValue95% CI
Co-Ad Group30.526.1 – 35.1
Control Group22.018.1 – 26.3
Fatigue, Dosing at Day 31
GroupValue95% CI
Control Group23.519.4 – 28.0
Fever, Dosing at Day 1
GroupValue95% CI
Co-Ad Group2.11.0 – 4.0
Control Group0.70.1 – 2.1
Fever, Dosing at Day 31
GroupValue95% CI
Control Group2.00.9 – 3.9
Headache, Dosing at Day 1
GroupValue95% CI
Co-Ad Group24.320.3 – 28.7
Control Group17.113.6 – 21.1
Headache, Dosing at Day 31
GroupValue95% CI
Control Group19.015.3 – 23.2
Percentage of Participants Reporting Unsolicited Adverse Events (AEs) Secondary · Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)

An unsolicited AEs is an AE that is not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs).

GroupValue95% CI
Co-Ad Group12.29.5 – 15.3
Control Group13.510.6 – 16.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Co-Ad Group
Serious: 12/516 (2%)
Deaths: 1/516
Control Group
Serious: 15/513 (3%)
Deaths: 0/513

Serious adverse events (34 terms)

ReactionSystemCo-Ad GroupControl Group
Pulmonary embolismRespiratory, thoracic and mediastinal disorders——
COVID-19Infections and infestations——
Diverticulitis intestinal haemorrhagicInfections and infestations——
GastroenteritisInfections and infestations——
InfluenzaInfections and infestations——
PneumoniaInfections and infestations——
Pneumonia respiratory syncytial viralInfections and infestations——
Spinal cord infectionInfections and infestations——
Cardiac failure congestiveCardiac disorders——
Angina pectorisCardiac disorders——
Angina unstableCardiac disorders——
Arteriosclerosis coronary arteryCardiac disorders——
Sinus node dysfunctionCardiac disorders——
Carotid artery stenosisNervous system disorders——
HemiparesisNervous system disorders——
Intraventricular haemorrhageNervous system disorders——
SyncopeNervous system disorders——
Thalamus haemorrhageNervous system disorders——
Transient ischaemic attackNervous system disorders——
AsthmaRespiratory, thoracic and mediastinal disorders——
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders——
Respiratory failureRespiratory, thoracic and mediastinal disorders——
Brain neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Clear cell renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Other adverse events (106 terms — click to expand)

ReactionSystemCo-Ad GroupControl Group
Injection site painGeneral disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
FatigueGeneral disorders——
HeadacheNervous system disorders——
ArthralgiaMusculoskeletal and connective tissue disorders——
Injection site swellingGeneral disorders——
Injection site erythemaGeneral disorders——
PyrexiaGeneral disorders——
COVID-19Infections and infestations——
CoughRespiratory, thoracic and mediastinal disorders——
DiarrhoeaGastrointestinal disorders——
Upper respiratory tract infectionInfections and infestations——
ChillsGeneral disorders——
BronchitisInfections and infestations——
SinusitisInfections and infestations——
Nasal congestionRespiratory, thoracic and mediastinal disorders——
RhinorrhoeaRespiratory, thoracic and mediastinal disorders——
Back painMusculoskeletal and connective tissue disorders——
NasopharyngitisInfections and infestations——
InfluenzaInfections and infestations——
NauseaGastrointestinal disorders——
Ear painEar and labyrinth disorders——
Injection site pruritusGeneral disorders——
PainGeneral disorders——
Respiratory tract infectionInfections and infestations——
Urinary tract infectionInfections and infestations——
VomitingGastrointestinal disorders——
Abdominal pain upperGastrointestinal disorders——
Procedural painInjury, poisoning and procedural complications——
VertigoEar and labyrinth disorders——
RashSkin and subcutaneous tissue disorders——
InsomniaPsychiatric disorders——
Administration site erythemaGeneral disorders——
Administration site painGeneral disorders——
Administration site pruritusGeneral disorders——
AstheniaGeneral disorders——
Influenza like illnessGeneral disorders——
Injection site paraesthesiaGeneral disorders——
Muscle spasmsMusculoskeletal and connective tissue disorders——
ArthritisMusculoskeletal and connective tissue disorders——

Most-reported serious reactions: Pulmonary embolism, COVID-19, Diverticulitis intestinal haemorrhagic, Gastroenteritis, Influenza, Pneumonia, Pneumonia respiratory syncytial viral, Spinal cord infection.

Data from ClinicalTrials.gov NCT05559476 adverse events section.

Sponsor's own description

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Respiratory Syncytial Virus Vaccines: A Review of the Candidates and the Approved Vaccines.
    Topalidou X, Kalergis AM, Papazisis G. · · 2023 · cited 84× · PMID 37887775 · DOI 10.3390/pathogens12101259
  2. The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.
    Terstappen J, Hak SF, Bhan A, Bogaert D, et al · · 2024 · cited 54× · PMID 39326422 · DOI 10.1016/s1473-3099(24)00455-9
  3. Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.
    Li Q, Li H, Li Z, Wang Y. · · 2024 · cited 16× · PMID 39575302 · DOI 10.1002/mco2.70016
  4. New Insights on Respiratory Syncytial Virus Prevention.
    Kopera E, Czajka H, Zapolnik P, Mazur A. · · 2023 · cited 16× · PMID 38140201 · DOI 10.3390/vaccines11121797
  5. Clinical Characterization of Respiratory Syncytial Virus Infection in Adults: A Neglected Disease?
    Estofolete CF, Banho CA, Verro AT, Gandolfi FA, et al · · 2023 · cited 12× · PMID 37766255 · DOI 10.3390/v15091848
  6. Global progress in clinical research on human respiratory syncytial virus vaccines.
    Peng R, Chen C, Chen Q, Zhang Y, et al · · 2024 · cited 8× · PMID 39286350 · DOI 10.3389/fmicb.2024.1457703
  7. Randomized, Open-Label Phase 3 Study Evaluating Immunogenicity, Safety, and Reactogenicity of RSVPreF3 OA Coadministered with FLU-QIV-HD in Adults Aged ≥ 65.
    Buynak R, Cannon K, DeAtkine D, Kirby J, et al · · 2024 · cited 8× · PMID 38981954 · DOI 10.1007/s40121-024-00985-4
  8. Respiratory Syncytial Virus Vaccines: Analysis of Pre-Marketing Clinical Trials for Immunogenicity in the Population over 50 Years of Age.
    Papazisis G, Topalidou X, Gioula G, González PA, et al · · 2024 · cited 8× · PMID 38675736 · DOI 10.3390/vaccines12040353

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