Streptococcus PneumoniaePhase 1NCT00814489

Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

A Phase 1 study testing GSK2231395A and Engerix-B in people with Streptococcus Pneumoniae and Haemophilus Influenzae, run by GlaxoSmithKline at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Streptococcus Pneumoniae, Haemophilus Influenzae
What is being tested?: GSK2231395A and Engerix-B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSweden
Study dates: 8 Jan 2009to 10 Jun 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Subject 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.
If the subject is female, and of childbearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.

Who cannot join

Pneumonia within 3 years prior to 1st vaccination.
Invasive Pneumococcal Disease within 3 years prior to 1st vaccination.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines, with the exception of the influenza vaccine which can be administered >14 days prior to or >14 days following vaccine doses 1 and 2.
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.

Show all 18Show fewer

Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
History of reaction or hypersensitivity to any component of the vaccine.
Any serious, uncontrolled disease likely to interfere with the study as determined by history, physical examination or laboratory screening, as per the judgment of the Investigator.
Inflammatory processes such as known chronic infections.
All past or current malignancies and lymphoproliferative disorders.
Laboratory evidence of haematological and biochemical abnormalities.
Acute disease at the time of enrolment/vaccination.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
History of chronic alcohol consumption and/or drug abuse.
Other conditions that the principal investigator judges may interfere with study findings.
Previous vaccination for hepatitis B. As a portion of the subjects will be randomized to receive Engerix-B comparator, it is important that all subjects meet Engerix-B eligibility criteria.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

GSK Investigational Site
Karlskrona, SE-371 41

Other trials in Sweden

About this study

Official title: A Study to Evaluate GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Healthy Young Adults

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.

Read the detailed description

This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.

Conditions: Streptococcus Pneumoniae, Haemophilus Influenzae
Being tested: GSK2231395A, Engerix-B
Keywords: Non-typable Haemophilus influenzae, protein vaccine, Streptococcus pneumoniae, young adults
Medical subject headings: Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2231395ABiological
Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.
Engerix-BBiological
Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.

Study groups in NCT00814489
Study group	Role	What they receive
GSK2254233A Group	Experimental	Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: GSK2231395A
GSK2254232A Group	Experimental	Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: GSK2231395A
Engerix Group	Active comparator	Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: Engerix-B

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Any Solicited Local and General Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade.
Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination.
Measured: During a 7-day follow up period after any vaccination
Number of Subjects With Any Unsolicited Adverse Events (AE)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Measured: During a 30-day (Days 0-29) follow up period after any vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Measured: From Day 0 to Day 420
Number of Subjects With Any Biochemical Laboratory Abnormalities
Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE).
Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Measured: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420
Number of Subjects With Any Hematological Laboratory Abnormalities
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.
This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3.
Measured: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Number of Subjects With Any Hematological Laboratory Abnormalities
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.
This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Measured: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.

Secondary outcomes (3)

Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.
Measured: Days 0, 30, 60, 90, 180 and 420.
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations:
Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17.
Measured: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations:
C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17).
Measured: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 200910 Jun 2010

First posted25 Dec 2008 (estimated)
Study start8 Jan 2009
Primary completion4 May 2009
Study completion10 Jun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Streptococcus PneumoniaeStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814489
Sponsor's protocol ID: 112076
Status last verified: Jul 2013
First submitted: 23 Dec 2008
Last updated: 8 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Berglund J, Vink P, Tavares Da Silva F, Lestrate P, Boutriau D. Safety, immunogenicity, and antibody persistence following an investigational Streptococcus pneumoniae and Haemophilus influenzae triple-protein vaccine in a phase 1 randomized controlled study in healthy adults. Clin Vaccine Immunol. 2014 Jan;21(1):56-65. doi: 10.1128/CVI.00430-13. Epub 2013 Oct 30.
PubMed 24173029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive

All Streptococcus Pneumoniae trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Healthy Young Adults
ClinicalTrials.gov ID: NCT00814489
Acronym / sponsor ID: 112076
Conditions: Streptococcus Pneumoniae, Haemophilus Influenzae
Keywords: Non-typable Haemophilus influenzae, protein vaccine, Streptococcus pneumoniae, young adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 8 Jan 2009
Primary completion: 4 May 2009 (actual)
Study completion: 10 Jun 2010 (actual)
First posted: 25 Dec 2008 (estimated)
Results: Posted 25 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
GSK2254233A Group	Experimental	Biological: GSK2231395ASubjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
GSK2254232A Group	Experimental	Biological: GSK2231395ASubjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Engerix Group	Active comparator	Biological: Engerix-BSubjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Subject 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.
If the subject is female, and of childbearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.

Key exclusion criteria (18 listed)

Pneumonia within 3 years prior to 1st vaccination.
Invasive Pneumococcal Disease within 3 years prior to 1st vaccination.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines, with the exception of the influenza vaccine which can be administered >14 days prior to or >14 days following vaccine doses 1 and 2.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK2231395ATwo doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.	Biological	GSK2254232A Group, GSK2254233A Group
Engerix-BTwo doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.	Biological	Engerix Group

Primary outcome

Number of Subjects With Any Solicited Local and General Symptoms
Time frame: During a 7-day follow up period after any vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade. Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination.
Number of Subjects With Any Unsolicited Adverse Events (AE)
Time frame: During a 30-day (Days 0-29) follow up period after any vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 420
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
Number of Subjects With Any Biochemical Laboratory Abnormalities
Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420
Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE). Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.
Number of Subjects With Any Hematological Laboratory Abnormalities
Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3.
Number of Subjects With Any Hematological Laboratory Abnormalities
Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges. This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3.

3 secondary outcomes

Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
Time frame: Days 0, 30, 60, 90, 180 and 420.
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Time frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Time frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.

Results and safety

Results posted to the registry on 25 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2254233A Group	15	13
GSK2254232A Group	17	17
Engerix Group	8	7

Primary outcome: Number of Subjects With Any Solicited Local and General Symptoms

Time frame: During a 7-day follow up period after any vaccination. Number. Unit: Subjects

Measure	GSK2254233A Group n = 15	GSK2254232A Group n = 17	Engerix Group n = 8
Any pain	15	16	4
Any redness	10	7	1
Any swelling	6	7	0
Any fatigue	12	13	5
Any gastrointestinal	4	6	1
Any headache	11	10	5
Any malaise	6	7	2
Any myalgia	13	8	3

Population analysed: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

Primary outcome: Number of Subjects With Any Unsolicited Adverse Events (AE)

Time frame: During a 30-day (Days 0-29) follow up period after any vaccination. Number. Unit: Subjects

Measure	GSK2254233A Group n = 15	GSK2254232A Group n = 17	Engerix Group n = 8
Value	10	10	6

Population analysed: The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

Primary outcome: Number of Subjects With Any Serious Adverse Events (SAEs)

Time frame: From Day 0 to Day 420. Number. Unit: Subjects

Measure	GSK2254233A Group n = 15	GSK2254232A Group n = 17	Engerix Group n = 8
Value	0	0	0

Population analysed: The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.

Primary outcome: Number of Subjects With Any Biochemical Laboratory Abnormalities

Time frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. Number. Unit: Subjects

Measure	GSK2254233A Group n = 15	GSK2254232A Group n = 17	Engerix Group n = 8
ALT, Pre Dose 1 (Day 0) [N=2,2,0]	0	0	NA
ALT, Post Dose 1 (Day 7) [N=15,17,8]	0	0	0
ALT, Post Dose 1 (Day 60) [N=15,17,7]	1	0	0
ALT, Post Dose 2 (Day 67) [N=15,17,7]	0	0	0
ALT, Post Dose 2 (Day 180) [N=14,17,7]	0	1	0
ALT, Post Dose 2 or 3 (Day 300) [N=15,16,6]	0	1	0
ALT, Post Dose 2 or 3 (Day 420) [N=14,16,7]	0	2	0
AST, Pre Dose 1 (Day 0) [N=2,3,0]	0	0	NA

Population analysed: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were collected up to Day 420, unsolicited adverse events during a 30-day period after each vaccine dose and solicited symptoms during a 7-day period after each vaccine dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2254233A Group	0 of 15 (0%)	15 of 15 (100%)	Not reported
GSK2254232A Group	0 of 17 (0%)	17 of 17 (100%)	Not reported
Engerix Group	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24173029Berglund J, Vink P, Tavares Da Silva F, Lestrate P, Boutriau D. Safety, immunogenicity, and antibody persistence following an investigational Streptococcus pneumoniae and Haemophilus influenzae triple-protein vaccine in a phase 1 randomized controlled study in healthy adults. Clin Vaccine Immunol. 2014 Jan;21(1):56-65. doi: 10.1128/CVI.00430-13. Epub 2013 Oct 30.

Related trials for Streptococcus Pneumoniae

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2231395A and Engerix-B in people with Streptococcus Pneumoniae and Haemophilus Influenzae, run by GlaxoSmithKline at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any Solicited Local and General Symptoms (time frame: During a 7-day follow up period after any vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.