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Phase 1 N=40 Randomized Double-blind Prevention

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

Streptococcus Pneumoniae · Haemophilus Influenzae

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Number of Subjects With Any Solicited Local and General Symptoms — 15; 16; 4; 10 Subjects

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
GSK2231395A (Biological); Engerix-B (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
May 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Any Solicited Local and General Symptoms
15; 16; 4; 10; 7; 1
PRIMARY
Number of Subjects With Any Unsolicited Adverse Events (AE)
10; 10; 6
PRIMARY
Number of Subjects With Any Serious Adverse Events (SAEs)
0; 0; 0
PRIMARY
Number of Subjects With Any Biochemical Laboratory Abnormalities
0; 0; NA; 0; 0; 0
PRIMARY
Number of Subjects With Any Hematological Laboratory Abnormalities
0; 0; NA; 0; 0; 0
PRIMARY
Number of Subjects With Any Hematological Laboratory Abnormalities
0; 0; NA; 0; 0; 0
SECONDARY
Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)
128.4; 92.3; 286.9; 1314.4; 611.8; 274.9
SECONDARY
Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
13.4; 6.8; 10.4; 22.2; 7.7; 7.2
SECONDARY
Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
-65.0; 28.0; 3.3; -164.8; -20.7; -44.3

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00814489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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