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

NCT ID: NCT00814489

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-08
• Study Completion Date: 2010-06-10

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.

Conditions

Streptococcus Pneumoniae; Haemophilus Influenzae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GSK2254233A Group

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.

Group Type: EXPERIMENTAL

GSK2231395A

Intervention Type: BIOLOGICAL

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.

GSK2254232A Group

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.

Group Type: EXPERIMENTAL

GSK2231395A

Intervention Type: BIOLOGICAL

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 Group

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.

Group Type: ACTIVE_COMPARATOR

Engerix-B

Intervention Type: BIOLOGICAL

Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.

Interventions

GSK2231395A

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.

Intervention Type: BIOLOGICAL

Engerix-B

Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Karlskrona, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 24173029 (View on PubMed)

Other Identifiers

112076

Identifier Type: -

Identifier Source: org_study_id