Moderate to Severe AsthmaPhase 3VECTORNCT05062759

Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma

A Phase 3 study testing Tezepelumab in people with Moderate to Severe Asthma, run by AstraZeneca at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous [SC] every 4 weeks [Q4W]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022… Read more about this study

Who is it for?: Ages 12 to 21 years
Conditions the study is for: Moderate to Severe Asthma
What is being tested?: Tezepelumab
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 15 sitesUnited States
Study dates: 23 Aug 2021to 18 Jul 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
Morning pre-bronchodilator FEV1 (Forced expiratory volume) of > 50% predicted normal value at Visit 1 or Visit 2.
Body weight ≥ 40 kg.
For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.
Must have 'not well-controlled' asthma.

Who cannot join

Clinically important pulmonary disease other than asthma.
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
Life-threatening asthma
History of cancer.
Allergy to eggs, if egg based influenza vaccine will be administered.
History of anaphylaxis to any biologic therapy.

Show all 9Show fewer

Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
History of alcohol or drug abuse within 12 months prior to the date of informed consent.
Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Research Site
Bakersfield, California, 93301
Research Site
Columbia, Missouri, 65203
Research Site
Dallas, Texas, 75225
Research Site
Dayton, Ohio, 45406
Research Site
Edmond, Oklahoma, 73034
Research Site
Huntington Beach, California, 92647
Research Site
Miami, Florida, 33133
Research Site
Milwaukee, Wisconsin, 53228
Research Site
Northfield, New Jersey, 08225
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Salt Lake City, Utah, 84107
Research Site
San Antonio, Texas, 78229
Research Site
Toledo, Ohio, 43617
Research Site
Tyler, Texas, 75708
Research Site
Waco, Texas, 76712

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)

Read the detailed description

Participants with moderate to severe asthma will enter the screening period of a minimum of 2 weeks to allow adequate time for all of the eligibility criteria to be evaluated. They will be randomized 1:1 to receive tezepelumab 210 mg or placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Randomization will be monitored to ensure at least 50% of the randomized participants are between the ages of 12 to 17 years.

Participants will receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

Serum samples for evaluation of antibody response will be drawn at Week 12 (pre-vaccination) and at Week 16 (4 weeks post-vaccination) when humoral response to the vaccination is expected to be fully developed.

The End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and the End of Study Visit will be conducted at Week 28.

Conditions: Moderate to Severe Asthma
Being tested: Tezepelumab, Placebo
Keywords: Tezepelumab, Humoral Immune Response, Quadrivalent Influenza Vaccination, Antibody response, Subcutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TezepelumabDrug
210 mg SC injection Q4W.
PlaceboDrug
SC injection Q4W.

Study groups in NCT05062759
Study group	Role	What they receive
Tezepelumab	Experimental	Participants will be randomized to receive tezepelumab 210 mg administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention. Receives: Drug: Tezepelumab
Placebo to Tezepelumab	Placebo comparator	Participants will be randomized to receive placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Measured: From Week 12 to Week 16
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Measured: From Week 12 to Week 16
Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Measured: Week 16
Post-vaccination Strain-specific Serum MN Antibody GMTs
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Measured: Week 16
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Measured: Week 16
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
Measured: Week 16
Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Measured: Week 16
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Measured: Week 16

Secondary outcomes (2)

Serum Tezepelumab Concentrations
Tezepelumab serum concentrations were summarized using descriptive statistics at each visit.
Measured: Week 0, Week 12, Week 16 and Week 28
Immunogenicity
Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA.
Measured: From Baseline to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 202118 Jul 2022

First posted30 Sep 2021
Study start23 Aug 2021
Primary completion21 Mar 2022
Study completion18 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Moderate to Severe AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05062759
Sponsor's protocol ID: D5180C00031
Acronym: VECTOR
Status last verified: Jun 2023
First submitted: 23 Aug 2021
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Cole J, Capala-Szczurko I, Roseti S, Chen C, Caveney S, Aksyuk AA, Streicher K, Ponnarambil S, Colice G. Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study. Pulm Ther. 2024 Mar;10(1):53-67. doi: 10.1007/s41030-023-00245-9. Epub 2023 Dec 8.
PubMed 38064153

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)
ClinicalTrials.gov ID: NCT05062759
Acronym / sponsor ID: VECTOR / D5180C00031
Conditions: Moderate to Severe Asthma
Keywords: Tezepelumab, Humoral Immune Response, Quadrivalent Influenza Vaccination, Antibody response, Subcutaneous
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Amgen
Study start: 23 Aug 2021 (actual)
Primary completion: 21 Mar 2022 (actual)
Study completion: 18 Jul 2022 (actual)
First posted: 30 Sep 2021 (actual)
Results: Posted 21 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

The End of Treatment (EOT) Visit will be conducted at Week 16 and a final Follow-up Visit and the End of Study Visit will be conducted at Week 28.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Tezepelumab	Experimental	Drug: TezepelumabParticipants will be randomized to receive tezepelumab 210 mg administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.
Placebo to Tezepelumab	Placebo comparator	Drug: PlaceboParticipants will be randomized to receive placebo SC Q4W, administered at Weeks 0, 4, 8 and 12. Participants will also receive a single dose of inactivated quadrivalent seasonal influenza vaccine intramuscularly at Week 12, prior to the fourth dose of study intervention.

Who may qualify

Ages: 12 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
Morning pre-bronchodilator FEV1 (Forced expiratory volume) of > 50% predicted normal value at Visit 1 or Visit 2.
Body weight ≥ 40 kg.
For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3.
Must have 'not well-controlled' asthma.

Key exclusion criteria (9 listed)

Clinically important pulmonary disease other than asthma.
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment.
Life-threatening asthma
History of cancer.
Allergy to eggs, if egg based influenza vaccine will be administered.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tezepelumab210 mg SC injection Q4W.	Drug	Tezepelumab
PlaceboSC injection Q4W.	Drug	Placebo to Tezepelumab

Primary outcome

Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)
Time frame: From Week 12 to Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs
Time frame: From Week 12 to Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)
Time frame: Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Post-vaccination Strain-specific Serum MN Antibody GMTs
Time frame: Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer
Time frame: Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer
Time frame: Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40
Time frame: Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. HAI assay was not performed for H3N2 strain due to the known low haemagglutination effect.
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40
Time frame: Week 16
Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.

2 secondary outcomes

Serum Tezepelumab Concentrations
Time frame: Week 0, Week 12, Week 16 and Week 28
Immunogenicity
Time frame: From Baseline to Week 28

Results and safety

Results posted to the registry on 21 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tezepelumab	35	34
Placebo	35	34

Primary outcome: Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs)

Time frame: From Week 12 to Week 16. Geometric mean (Geometric Coefficient of Variation). Unit: Fold change

Measure	Tezepelumab n = 33	Placebo n = 33
Influenza A H1N1	7.34 (1.361)	4.75 (1.455)
Influenza B Yamagata Lineage	1.76 (0.955)	1.46 (0.937)
Influenza B Victoria Lineage	2.94 (1.054)	2.90 (0.841)

Tezepelumab vs Placebo: Geometric Least square (LS) mean ratio: 0.65 (90% CI 0.43 to 0.98)
Tezepelumab vs Placebo: Geometeric LS mean ratio: 0.83 (90% CI 0.60 to 1.15)
Tezepelumab vs Placebo: Geometric LS mean ratio: 0.99 (90% CI 0.71 to 1.37)

Population analysed: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or Microneutralization antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Primary outcome: Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs

Time frame: From Week 12 to Week 16. Geometric mean (Geometric Coefficient of Variation). Unit: Fold change

Measure	Tezepelumab n = 33	Placebo n = 33
Influenza A H1N1	14.56 (2.581)	10.62 (2.409)
Influenza A H3N2	4.73 (1.509)	5.90 (3.180)
Influenza B Yamagata Lineage	4.00 (1.541)	3.56 (2.206)
Influenza B Victoria Lineage	4.08 (2.279)	5.04 (1.723)

Tezepelumab vs Placebo: Geometeric LS mean ratio: 0.73 (90% CI 0.42 to 1.28)
Tezepelumab vs Placebo: Geometeric LS mean ratio: 1.25 (90% CI 0.72 to 2.17)
Tezepelumab vs Placebo: Geometric LS mean ratio: 1.23 (90% CI 0.73 to 2.07)

Population analysed: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Primary outcome: Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs)

Time frame: Week 16. Geometric mean (Geometric Coefficient of Variation). Unit: Titer

Measure	Tezepelumab n = 33	Placebo n = 33
Influenza A H1N1	809.23 (0.921)	596.76 (1.076)
Influenza B Yamagata Lineage	167.46 (0.925)	161.56 (0.688)
Influenza B Victoria Lineage	194.68 (1.089)	200.55 (0.948)

Tezepelumab vs Placebo: Geometeric LS mean ratio: 0.74 (90% CI 0.52 to 1.04)
Tezepelumab vs Placebo: Geometeric LS mean ratio: 0.96 (90% CI 0.72 to 1.29)
Tezepelumab vs Placebo: Geometric LS mean ratio: 1.03 (90% CI 0.73 to 1.46)

Population analysed: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Primary outcome: Post-vaccination Strain-specific Serum MN Antibody GMTs

Time frame: Week 16. Geometric mean (Geometric Coefficient of Variation). Unit: Titer

Measure	Tezepelumab n = 33	Placebo n = 33
Influenza A H1N1	382.55 (1.469)	303.63 (1.667)
Influenza A H3N2	600.92 (2.154)	457.33 (2.336)
Influenza B Yamagata Lineage	355.44 (1.076)	366.81 (1.270)
Influenza B Victoria Lineage	125.67 (4.687)	124.35 (3.515)

Tezepelumab vs Placebo: Geometeric LS mean ratio: 0.79 (90% CI 0.51 to 1.25)
Tezepelumab vs Placebo: Geometeric LS mean ratio: 0.76 (90% CI 0.42 to 1.28)
Tezepelumab vs Placebo: Geometric LS mean ratio: 0.99 (90% CI 0.49 to 1.99)

Population analysed: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tezepelumab	0 of 35 (0%)	14 of 35 (40%)	0 of 35
Placebo	1 of 35 (2.9%)	15 of 35 (42.9%)	1 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38064153Cole J, Capala-Szczurko I, Roseti S, Chen C, Caveney S, Aksyuk AA, Streicher K, Ponnarambil S, Colice G. Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Patients with Moderate to Severe Asthma: The Phase 3b VECTOR Study. Pulm Ther. 2024 Mar;10(1):53-67. doi: 10.1007/s41030-023-00245-9. Epub 2023 Dec 8.
CSR Synopsis\_RedactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tezepelumab in people with Moderate to Severe Asthma, run by AstraZeneca at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) (time frame: From Week 12 to Week 16). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062759, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.