NCT01678677

Brief Summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

3 active sites

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 23, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2014

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

August 23, 2012

Last Update Submit

May 12, 2017

Conditions

Respiratory Disorders

Keywords

non-typeable Haemophilus influenzaeimmunogenicityreactogenicitysafety

Outcome Measures

Primary Outcomes (7)

  • Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.

    During a 7-day follow-up period (from day 0 to day 6) after each vaccination.

  • Occurrence of any unsolicited AE, in all subjects, in all groups.

    During a 30-day follow-up period (from day 0 to day 29) after each vaccination.

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

    Prior to each vaccination.

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

    7 days after each vaccination.

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

    At study conclusion (Day 420).

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

    From first vaccination (Day 0) to study conclusion (Day 420).

  • Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.

    From first vaccination (Day 0) to study conclusion (Day 420).

Secondary Outcomes (2)

  • Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.

    Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).

  • Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.

    Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).

Study Arms (10)

Group A

EXPERIMENTAL

Subjects in this group will receive formulation 1 of NTHi vaccine.

Biological: NTHI vaccine GSK2838500A (formulation 1)

Group B

EXPERIMENTAL

Subjects in this group will receive formulation 2 of NTHi vaccine.

Biological: NTHI vaccine GSK2838501A (formulation 2)

Group C

EXPERIMENTAL

Subjects in this group will receive formulation 3 of NTHi vaccine.

Biological: NTHI vaccine GSK2838502A (formulation 3)

Group D

EXPERIMENTAL

Subjects in this group will receive formulation 4 of NTHi vaccine.

Biological: NTHI vaccine GSK2838503A (formulation 4)

Group E

EXPERIMENTAL

Subjects in this group will receive formulation 5 of NTHi vaccine and a placebo.

Biological: NTHI vaccine GSK2838504A (formulation 5)

Group F

EXPERIMENTAL

Subjects in this group will receive formulation 6 of NTHi vaccine and a placebo.

Biological: NTHI vaccine GSK2838505A (formulation 6)

Group G

EXPERIMENTAL

Subjects in this group will receive formulation 7 of NTHi vaccine and a placebo.

Biological: NTHI vaccine GSK2838508A (formulation 7)

Group H

EXPERIMENTAL

Subjects in this group will receive formulation 8 of NTHi vaccine and a placebo.

Biological: NTHI vaccine GSK2838509A (formulation 8)

Group Placebo 1

PLACEBO COMPARATOR

Subjects in this group will receive placebo.

Drug: Placebo comparator

Group Placebo 2

PLACEBO COMPARATOR

Subjects in this group will receive placebo.

Drug: Placebo comparator

Interventions

NTHI vaccine GSK2838500A (formulation 1)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group A
NTHI vaccine GSK2838501A (formulation 2)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group B
NTHI vaccine GSK2838502A (formulation 3)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group C
NTHI vaccine GSK2838503A (formulation 4)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group D
NTHI vaccine GSK2838504A (formulation 5)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group E
NTHI vaccine GSK2838505A (formulation 6)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group F
NTHI vaccine GSK2838508A (formulation 7)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group G
NTHI vaccine GSK2838509A (formulation 8)BIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group H
Placebo comparatorDRUG

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Group Placebo 1Group Placebo 2

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 50 and 70 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Subjects without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol.
  • Current or former smokers.
  • A smoking history of at least 10 pack-years.
  • 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 vaccine, 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 not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
  • Previous vaccination with any vaccine containing NTHi-antigens.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current autoimmune disease.
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \< 80% of predicted normal value.
  • Diagnosed with a respiratory disorder. Please note that subjects with mild pulmonary obstruction can be enrolled.
  • Laboratory evidence of clinically significant haematological abnormalities at Screening.
  • Acute disease and/or fever at the time of enrolment.
  • Current alcoholism and/or drug abuse.
  • Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
  • History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Antwerp, 2060, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

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, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 5, 2012

Study Start

August 31, 2012

Primary Completion

January 30, 2014

Study Completion

January 30, 2014

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

BE(3)