NCT01657526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

August 8, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2013

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

August 2, 2012

Last Update Submit

May 12, 2017

Conditions

Respiratory Disorders

Keywords

Healthy adultsSafetyReactogenicityImmunogenicityNon-typeable H. Influenzae (NTHi)

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups

    At baseline (Screening visit) and after each vaccination.

  • Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups

    From first vaccination to study conclusion (Day 420).

  • Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups

    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

    Prior to each vaccination and 30 days post each vaccination.

Study Arms (4)

Group A

EXPERIMENTAL

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

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

Biological: Saline placebo

Group C

EXPERIMENTAL

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

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

Biological: Saline placebo

Interventions

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

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

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

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

Group C
Saline placeboBIOLOGICAL

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

Group BGroup D

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Related Links

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

August 8, 2012

Primary Completion

November 25, 2013

Study Completion

November 25, 2013

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

AU(1)