- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171989
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children
The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bydgoszcz, Poland, 85-021
- GSK Investigational Site
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Debica, Poland, 39-200
- GSK Investigational Site
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Krakow, Poland, 31-503
- GSK Investigational Site
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Krakow, Poland, 31-422
- GSK Investigational Site
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Siemianowice Slaskie, Poland, 41-103
- GSK Investigational Site
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Tarnow, Poland, 33-100
- GSK Investigational Site
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Torun, Poland
- GSK Investigational Site
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Trzebnica, Poland, 55-100
- GSK Investigational Site
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Wroclaw, Poland, 50345
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
- A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
- Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
- Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
- Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
The following adverse event having occurred after previous administration of DTP vaccine:
- Encephalopathy.
- Temperature of >= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting >= 3 hours.
- Seizures with or without fever occurring within 3 days of vaccination.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
• Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GSK2202083A + SYNFLORIX GROUP
Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1.
Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
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Intramuscular, one dose.
Intramuscular, one dose.
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Active Comparator: INFANRIX HEXA/MENJUGATE GROUP
Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
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Intramuscular, one dose.
Intramuscular, one dose.
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Active Comparator: INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP
Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1.
Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
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Intramuscular, one dose.
Intramuscular, one dose.
Intramuscular, one dose.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
Time Frame: At Month 1, post-booster dose
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A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).
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At Month 1, post-booster dose
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Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)
Time Frame: At Month 1, post-booster dose
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A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
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At Month 1, post-booster dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seropositive Subjects for Anti-PRP
Time Frame: At Month 0, before the booster dose
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A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.
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At Month 0, before the booster dose
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Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Anti-PRP Antibody Concentrations
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Number of Seroprotected Subjects Against rSBA-MenC
Time Frame: At Month 0, before the booster dose
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A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.
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At Month 0, before the booster dose
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Number of Seropositive Subjects for Anti-rSBA-MenC
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.
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At Month 0 and Month 1, before and one month after booster dose
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Anti-rSBA-MenC Antibody Titres
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.
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At Month 0 and Month 1, before and one month after booster dose
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Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Anti-PSC Antibody Concentrations
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
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At Month 0 and Month 1, before and one month after booster dose
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Anti-D and Anti-T Antibody Concentrations
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Anti-HBs Antibody Concentrations
Time Frame: At Month 0 and Month 1, before and after booster dose
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Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
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At Month 0 and Month 1, before and after booster dose
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Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.
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At Month 0 and Month 1, before and one month after booster dose
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Anti-poliovirus Types 1, 2 and 3 Antibody Titres
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.
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At Month 0 and Month 1, before and one month after booster dose
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Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
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At Month 0 and Month 1, before and one month after booster dose
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Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time Frame: At Month 0 and Month 1, before and one month after booster dose
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Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.
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At Month 0 and Month 1, before and one month after booster dose
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Number of Subjects With Any Solicited Local Symptoms
Time Frame: During the 8-day (Days 0-7) post-booster period
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Solicited local symptoms assessed included pain, redness and swelling.
Any= all reports of the speecified symptom irrespective of intensity grade.
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During the 8-day (Days 0-7) post-booster period
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Number of Subjects With Any Solicited General Symptoms
Time Frame: During the 8-day (Days 0-7) post-booster period
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Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C).
Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.
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During the 8-day (Days 0-7) post-booster period
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Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: During the 31-day (Days 0-30) post-booster period
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An unsolicited AE was any AE (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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During the 31-day (Days 0-30) post-booster period
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)
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SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Neurologic Manifestations
- Liver Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Neuromuscular Manifestations
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Orthomyxoviridae Infections
- Clostridium Infections
- Hypocalcemia
- Calcium Metabolism Disorders
- Corynebacterium Infections
- Myelitis
- Hepatitis B
- Hepatitis
- Hepatitis A
- Influenza, Human
- Tetanus
- Diphtheria
- Tetany
- Poliomyelitis
Other Study ID Numbers
- 113978
- 2010-019253-18 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
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Statistical Analysis Plan
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 113978Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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