Respiratory DisordersPhase 1NCT01657526
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
A Phase 1 study testing GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A) and GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A) in people with Respiratory Disorders, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disorders
- What is being tested?
- GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A) and GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Aug 2012to 25 Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history, physical examination and laboratory assessment before entering into the study.
- 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:
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- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, 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.
- Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines.
- Previous vaccination with a vaccine containing NTHi antigens.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. Topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccines or planned administration during the study period.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Laboratory evidence of clinically significant haematological (complete blood cell count [Red Blood Cells (RBC), White Blood Cells (WBC)], WBC differential count, platelets count and haemoglobin level) and biochemical (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], creatinine and lactate dehydrogenase [LDH]) abnormalities as per the opinion of the investigator based on the local laboratory normative data.
- Acute disease and/or fever at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
- Malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any other condition that the investigator judges may interfere with study findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Healthy Adults
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
- Conditions
- Respiratory Disorders
- Being tested
- GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A), GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A), Saline placebo
- Keywords
- Healthy adults, Safety, Reactogenicity, Immunogenicity, Non-typeable H. Influenzae (NTHi)
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)Biological
Administered intramuscularly (IM) in the deltoid region of non-dominant arm
GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)Biological
2 doses administered IM in the deltoid region of non-dominant arm
Saline placeboBiological
2 doses administered IM in the deltoid region of non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study Receives: Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A) |
| Group B | Placebo comparator | Subjects in this group will receive placebo in Step 1 of the study Receives: Biological: Saline placebo |
| Group C | Experimental | Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study Receives: Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A) |
| Group D | Placebo comparator | Subjects in this group will receive placebo in Step 2 of the study Receives: Biological: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
Measured: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
Measured: During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
Measured: At baseline (Screening visit) and after each vaccination.
Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
Measured: From first vaccination to study conclusion (Day 420).
Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
Measured: From first vaccination to study conclusion (Day 420).
Secondary outcomes (1)
Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
Measured: Prior to each vaccination and 30 days post each vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study start8 Aug 2012
- Primary completion25 Nov 2013
- Study completion25 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657526
- Sponsor's protocol ID
- 116018
- Status last verified
- May 2017
- First submitted
- 2 Aug 2012
- Last updated
- 15 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. 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 GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01657526
- Acronym / sponsor ID
- 116018
- Conditions
- Respiratory Disorders
- Keywords
- Healthy adults, Safety, Reactogenicity, Immunogenicity, Non-typeable H. Influenzae (NTHi)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2012 (actual)
- Primary completion
- 25 Nov 2013 (actual)
- Study completion
- 25 Nov 2013 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
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 evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study |
| Group B | Placebo comparator | Biological: Saline placeboSubjects in this group will receive placebo in Step 1 of the study |
| Group C | Experimental | Biological: GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study |
| Group D | Placebo comparator | Biological: Saline placeboSubjects in this group will receive placebo in Step 2 of the study |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history, physical examination and laboratory assessment before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
Key exclusion criteria (16 listed)
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, 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.
- Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines.
- Previous vaccination with a vaccine containing NTHi antigens.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. 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 |
|---|---|---|
| GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)Administered intramuscularly (IM) in the deltoid region of non-dominant arm | Biological | Group A |
| GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)2 doses administered IM in the deltoid region of non-dominant arm | Biological | Group C |
| Saline placebo2 doses administered IM in the deltoid region of non-dominant arm | Biological | Group B, Group D |
Primary outcome
Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
Time frame: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
Time frame: During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
Time frame: At baseline (Screening visit) and after each vaccination.
Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
Time frame: From first vaccination to study conclusion (Day 420).
Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
Time frame: From first vaccination to study conclusion (Day 420).
1 secondary outcome
Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
Time frame: Prior to each vaccination and 30 days post each vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Results for study 116018 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A) and GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A) in people with Respiratory Disorders, run by GlaxoSmithKline at 1 site in Australia.
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 9 inclusion and 16 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups (time frame: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.