Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

NCT ID: NCT01657526

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-08
• Study Completion Date: 2013-11-25

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.

Conditions

Respiratory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study

Group Type: EXPERIMENTAL

GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)

Intervention Type: BIOLOGICAL

Administered intramuscularly (IM) in the deltoid region of non-dominant arm

Group B

Subjects in this group will receive placebo in Step 1 of the study

Group Type: PLACEBO_COMPARATOR

Saline placebo

Intervention Type: BIOLOGICAL

2 doses administered IM in the deltoid region of non-dominant arm

Group C

Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study

Group Type: EXPERIMENTAL

GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)

Intervention Type: BIOLOGICAL

2 doses administered IM in the deltoid region of non-dominant arm

Group D

Subjects in this group will receive placebo in Step 2 of the study

Group Type: PLACEBO_COMPARATOR

Saline placebo

Intervention Type: BIOLOGICAL

2 doses administered IM in the deltoid region of non-dominant arm

Interventions

GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)

Administered intramuscularly (IM) in the deltoid region of non-dominant arm

Intervention Type: BIOLOGICAL

GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)

2 doses administered IM in the deltoid region of non-dominant arm

Intervention Type: BIOLOGICAL

Saline placebo

2 doses administered IM in the deltoid region of non-dominant arm

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

116018

Identifier Type: -

Identifier Source: org_study_id