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

Respiratory Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657526
• Other study ID #: 116018
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2012
• Last updated: May 12, 2017
• Start date: August 8, 2012
• Est. completion date: November 25, 2013

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 25, 2013
• Est. primary completion date: November 25, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Respiration Disorders
• Respiratory Disorders
• Respiratory Tract Diseases

Intervention

Biological:
• GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)
Administered intramuscularly (IM) in the deltoid region of non-dominant arm
• GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
2 doses administered IM in the deltoid region of non-dominant arm
• Saline placebo
2 doses administered IM in the deltoid region of non-dominant arm

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups		During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
Primary	Occurrence of any unsolicited AE, in all subjects, in all vaccine groups		During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
Primary	Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups		At baseline (Screening visit) and after each vaccination.
Primary	Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups		From first vaccination to study conclusion (Day 420).
Primary	Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups		From first vaccination to study conclusion (Day 420).
Secondary	Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups		Prior to each vaccination and 30 days post each vaccination.

External Links

•   Results for study 116018 can be found on the GSK Clinical Study Register