Respiratory DisordersPhase 1NCT02547974

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.

A Phase 1 study testing Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A, Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A and Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A in people with Respiratory Disorders, run by GlaxoSmithKline at 3 sites in Belgium.

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

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Disorders
What is being tested?: Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A, Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A and Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 3 sitesBelgium
Study dates: 31 Aug 2015to 31 Mar 2017
Phase: Phase 1
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

applicable for both Step 1 ((healthy volunteers) and Step 2 ([ex-]smokers)
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject:

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has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vacci-nation, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
only applicable for Step 1
A male or female between, and including, 18 and 40 years of age at the time of the Screening Visit.
Healthy subjects without acute or chronic, clinically sig-nificant pulmonary, cardiovascular, hepatic or renal func-tional abnormality, as determined by physical examination or laboratory screening tests.
only applicable for Step 2
A male or female between, and including, 50 and 70 years of age at the time of the screening visit.
Subjects without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol.
Current or former smoker with a cigarette smoking history ≥ 10 pack-years.

Who cannot join

applicable for both Step 1 and Step 2
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Previous vaccination with any vaccine containing NTHi and/or Mcat antigens.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Only topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.

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Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of or current autoimmune disease.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature >= 37.5°C for oral or axillary route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Current alcoholism and/or drug abuse.
History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
Malignancies within previous 5 years or lymphoproliferative disorders.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any other condition that the investigator judges may interfere with study findings.
only applicable for Step 1
Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
Laboratory evidence of clinically significant haematological (complete blood cell count [RBC, WBC], WBC differential count [lymphocytes, neutrophils and eosinophils], platelets count or haemoglobin level) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine) abnormalities as per the opinion of the investigator.
only applicable for Step 2
Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza or pneumococcal licensed vaccine which may be admin-istered ≥ 15 days preceding or following any study vaccine dose.
Post-bronchodilator FEV1 < 80% of predicted normal value.
Diagnosed with a respiratory disorder (e.g. asthma, COPD, sarcoidosis, tuberculosis, bronchiectasis, lung fi-brosis, pulmonary embolism, pneumothorax, or physi-cian confirmed lung cancer). Please note that subjects with mild pulmonary obstruction (i.e. FEV1/ FVC ratio < 0.7 with FEV1 ≥ 80% of normal predicted values [GOLD grade 1]) can be enrolled.
Has contraindication for spirometry testing (such as recent eye surgery, recent thoracic or abdominal surgery procedures, unstable cardiovascular status, recent myo-cardial infection or pulmonary embolism).
Laboratory evidence of clinically significant haematological (complete blood cell count [RBC, WBC], WBC differential count [lymphocytes, neutrophils and eosinophils], platelets count or haemoglobin level) and biochemical (ALT, AST or creatinine) abnormalities.
Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults

Conditions: Respiratory Disorders
Being tested: Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A, Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A, Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A, Placebo
Keywords: Safety, Immunogenicity, Reactogenicity
Medical subject headings: Respiration Disorders

What participants receive

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

Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513ABiological
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513ABiological
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036ABiological
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
PlaceboDrug
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule

Study groups in NCT02547974
Study group	Role	What they receive
GSK3277513A F1 Group	Experimental	Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. Receives: Biological: Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A
GSK3277513A F2 Group	Experimental	Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. Receives: Biological: Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A
GSK3277513A F3 Group	Experimental	Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. Receives: Biological: Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A
Placebo Group	Placebo comparator	Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. Receives: Drug: Placebo

What is being measured

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

Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (Day 60 to Day 66) after second dose
Number of Subjects With Any Solicited General Adverse Events (AEs)
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].
Measured: During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Number of Subjects With Any Solicited General Adverse Events (AEs)
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].
Measured: During a 7-day follow-up period (Day 60 to Day 66) after second dose.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During a 30-day follow-up period (Day 0 to Day 29) after first dose.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During a 30-day follow-up period (Day 60 to Day 89) after second dose
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.
Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 7, post-dose 1.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.
Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 60, post-dose 1.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.
Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 67, post-dose 2.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.
Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 210, post-dose 2.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.
Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Measured: At Day 420, post-dose 2.
Number of Subjects With Any Serious Adverse Events (SAEs)
Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From first vaccination up to study conclusion (Day 0 to Day 420)
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From first vaccination up to study conclusion (Day 0 to Day 420)

Secondary outcomes (7)

Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies.
Measured: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies.
Measured: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies.
Measured: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 16 EL.U/mL for anti-PilA antibodies.
Measured: At Day 210 and Day 420 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies.
Measured: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin [IL]-2, IL-13, IL-17, Interferon gamma [FN-γ], Tumour necrosis factor alpha [TNF-α] and CD40L). The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.
Measured: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.
Measured: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).

Timeline

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

31 Aug 201531 Mar 2017

First posted14 Sep 2015 (estimated)
Study start31 Aug 2015
Primary completion31 Mar 2017
Study completion31 Mar 2017

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 Respiratory DisordersStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547974
Sponsor's protocol ID: 201281
Other IDs: 2015-000378-36, 2015
Status last verified: Mar 2018
First submitted: 27 Aug 2015
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Van Damme P, Leroux-Roels G, Vandermeulen C, De Ryck I, Tasciotti A, Dozot M, Moraschini L, Testa M, Arora AK. Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine. Vaccine. 2019 May 21;37(23):3113-3122. doi: 10.1016/j.vaccine.2019.04.041. Epub 2019 Apr 24.
PubMed 31029515

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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.
ClinicalTrials.gov ID: NCT02547974
Acronym / sponsor ID: 201281
Conditions: Respiratory Disorders
Keywords: Safety, Immunogenicity, Reactogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 31 Aug 2015 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 23 Jul 2018

Clinical summary

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

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GSK3277513A F1 Group	Experimental	Biological: Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513ASubjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
GSK3277513A F2 Group	Experimental	Biological: Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513ASubjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
GSK3277513A F3 Group	Experimental	Biological: Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036ASubjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.
Placebo Group	Placebo comparator	Drug: PlaceboSubjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

applicable for both Step 1 ((healthy volunteers) and Step 2 ([ex-]smokers)
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:

Key exclusion criteria (28 listed)

applicable for both Step 1 and Step 2
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Previous vaccination with any vaccine containing NTHi and/or Mcat antigens.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Only topical steroids are allowed.

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
Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule	Biological	GSK3277513A F1 Group
Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule	Biological	GSK3277513A F2 Group
Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule	Biological	GSK3277513A F3 Group
Placebo2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule	Drug	Placebo Group

Primary outcome

Number of Subjects With Any Solicited Local Adverse Events (AEs)
Time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Time frame: During a 7-day follow-up period (Day 60 to Day 66) after second dose
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited General Adverse Events (AEs)
Time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].
Number of Subjects With Any Solicited General Adverse Events (AEs)
Time frame: During a 7-day follow-up period (Day 60 to Day 66) after second dose.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During a 30-day follow-up period (Day 0 to Day 29) after first dose.
Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During a 30-day follow-up period (Day 60 to Day 89) after second dose
Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Time frame: At Day 7, post-dose 1.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Time frame: At Day 60, post-dose 1.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Time frame: At Day 67, post-dose 2.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Time frame: At Day 210, post-dose 2.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Time frame: At Day 420, post-dose 2.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point.
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: From first vaccination up to study conclusion (Day 0 to Day 420)
Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination up to study conclusion (Day 0 to Day 420)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

7 secondary outcomes

Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Time frame: At Day 210 and Day 420 (post-dose2).
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
Time frame: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
Time frame: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).

Results and safety

Results posted to the registry on 23 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK3277513A F1 Group	15	14
GSK3277513A F2 Group	31	31
GSK3277513A F3 Group	30	30
PLACEBO Group	44	44

Primary outcome: Number of Subjects With Any Solicited Local Adverse Events (AEs)

Time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.. Count of participants. Unit: Participants

Measure	GSK3277513A F1 Group n = 15	GSK3277513A F2 Group n = 31	GSK3277513A F3 Group n = 30	PLACEBO Group n = 44
Any Pain	2	19	26	6
Any Redness (mm)	0	3	2	0
Any Swelling (mm)	0	4	0	0

Population analysed: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.

Primary outcome: Number of Subjects With Any Solicited Local Adverse Events (AEs)

Time frame: During a 7-day follow-up period (Day 60 to Day 66) after second dose. Count of participants. Unit: Participants

Measure	GSK3277513A F1 Group n = 14	GSK3277513A F2 Group n = 31	GSK3277513A F3 Group n = 29	PLACEBO Group n = 44
Any Pain	7	23	25	8
Any Redness (mm)	0	3	4	0
Any Swelling (mm)	0	2	3	0

Population analysed: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.

Primary outcome: Number of Subjects With Any Solicited General Adverse Events (AEs)

Time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.. Count of participants. Unit: Participants

Measure	GSK3277513A F1 Group n = 15	GSK3277513A F2 Group n = 31	GSK3277513A F3 Group n = 30	PLACEBO Group n = 44
Any Fatigue	3	3	11	10
Any Gastrointestinal symptoms	1	0	4	3
Any Headache	4	2	10	7
Any Myalgia	2	6	7	4
Any Temperature (Oral) (°C)	1	0	2	0

Population analysed: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.

Primary outcome: Number of Subjects With Any Solicited General Adverse Events (AEs)

Time frame: During a 7-day follow-up period (Day 60 to Day 66) after second dose.. Count of participants. Unit: Participants

Measure	GSK3277513A F1 Group n = 14	GSK3277513A F2 Group n = 31	GSK3277513A F3 Group n = 29	PLACEBO Group n = 44
Any Fatigue	3	9	13	6
Any Gastrointestinal symptoms	3	2	3	1
Any Headache	3	5	8	2
Any Myalgia	1	9	8	3
Any Temperature (Oral) (°C)	0	3	3	1

Population analysed: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms:within the 7-day post-vaccination period and Unsolicited AEs: during 30 days post- vaccination period. SAEs: during the whole study period (from Day 0 to Day 420). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK3277513A F1 Group	1 of 15 (6.7%)	11 of 15 (73.3%)	0 of 15
GSK3277513A F2 Group	0 of 31 (0%)	28 of 31 (90.3%)	0 of 31
GSK3277513A F3 Group	1 of 30 (3.3%)	29 of 30 (96.7%)	0 of 30
PLACEBO Group	2 of 44 (4.5%)	32 of 44 (72.7%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31029515Van Damme P, Leroux-Roels G, Vandermeulen C, De Ryck I, Tasciotti A, Dozot M, Moraschini L, Testa M, Arora AK. Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine. Vaccine. 2019 May 21;37(23):3113-3122. doi: 10.1016/j.vaccine.2019.04.041. Epub 2019 Apr 24.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 28 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 23 Jul 2018). 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?

Number of Subjects With Any Solicited Local Adverse Events (AEs) (time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.). The study lists 13 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 NCT02547974, 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 31 Aug 2018.