Clinical trial NCT01657526: Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Disorders
Keywords: Healthy adults
Safety
Reactogenicity
Immunogenicity
Non-typeable H. Influenzae (NTHi)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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:

  * 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
timeFrame: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
measure: Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
timeFrame: During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
measure: Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
timeFrame: At baseline (Screening visit) and after each vaccination.
measure: Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
timeFrame: From first vaccination to study conclusion (Day 420).
measure: Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
timeFrame: From first vaccination to study conclusion (Day 420).
Secondary outcomes:
measure: Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
timeFrame: Prior to each vaccination and 30 days post each vaccination.
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: