Clinical trial NCT00814489: Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
Official title: A Study to Evaluate GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Streptococcus Pneumoniae
Haemophilus Influenzae
Keywords: Non-typable Haemophilus influenzae
protein vaccine
Streptococcus pneumoniae
young adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Number of Subjects With Any Solicited Local and General Symptoms
timeFrame: During a 7-day follow up period after any vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AE)
timeFrame: During a 30-day (Days 0-29) follow up period after any vaccination
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 420
measure: Number of Subjects With Any Biochemical Laboratory Abnormalities
timeFrame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420
measure: Number of Subjects With Any Hematological Laboratory Abnormalities
timeFrame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
measure: Number of Subjects With Any Hematological Laboratory Abnormalities
timeFrame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Secondary outcomes:
measure: Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
timeFrame: Days 0, 30, 60, 90, 180 and 420.
measure: Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
timeFrame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
measure: Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
timeFrame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.