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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01171989
First received: July 27, 2010
Last updated: April 12, 2017
Last verified: February 2017
  Purpose

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).


Condition Intervention Phase
Tetanus Diphtheria Haemophilus Influenzae Type b Hepatitis B Poliomyelitis Acellular Pertussis Biological: GSK2202083A vaccine Biological: Infanrix hexa™ Biological: Menjugate™ Biological: NeisVac-C™ Biological: Synflorix™ Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) [ Time Frame: At Month 1, post-booster dose ]
    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).

  • Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC) [ Time Frame: At Month 1, post-booster dose ]
    A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.


Secondary Outcome Measures:
  • Number of Seropositive Subjects for Anti-PRP [ Time Frame: At Month 0, before the booster dose ]
    A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.

  • 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 ]
    The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.

  • Anti-PRP Antibody Concentrations [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.

  • Number of Seroprotected Subjects Against rSBA-MenC [ Time Frame: At Month 0, before the booster dose ]
    A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.

  • Number of Seropositive Subjects for Anti-rSBA-MenC [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.

  • Anti-rSBA-MenC Antibody Titres [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.

  • 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 ]
    The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.

  • Anti-PSC Antibody Concentrations [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.

  • 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 ]
    A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.

  • 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 ]
    The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.

  • Anti-HBs Antibody Concentrations [ Time Frame: At Month 0 and Month 1, before and after booster dose ]
    Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  • 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 ]
    A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.

  • Anti-poliovirus Types 1, 2 and 3 Antibody Titres [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.

  • 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 ]
    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).

  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: At Month 0 and Month 1, before and one month after booster dose ]
    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.

  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 8-day (Days 0-7) post-booster period ]
    Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: During the 8-day (Days 0-7) post-booster period ]
    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.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-booster period ]
    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.

  • Number of Subjects With Any 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) ]
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.


Enrollment: 391
Study Start Date: August 1, 2010
Study Completion Date: December 3, 2010
Primary Completion Date: December 3, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: GSK2202083A vaccine
Intramuscular, one dose.
Biological: Synflorix™
Intramuscular, one dose.
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.
Biological: Infanrix hexa™
Intramuscular, one dose.
Biological: Menjugate™
Intramuscular, one dose.
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.
Biological: Infanrix hexa™
Intramuscular, one dose.
Biological: NeisVac-C™
Intramuscular, one dose.
Biological: Synflorix™
Intramuscular, one dose.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171989

Locations
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-021
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Krakow, Poland, 31-422
GSK Investigational Site
Krakow, Poland, 31-503
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Tarnow, Poland, 33-100
GSK Investigational Site
Torun, Poland
GSK Investigational Site
Trzebnica, Poland, 55-100
GSK Investigational Site
Wroclaw, Poland, 50345
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 113978
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01171989     History of Changes
Other Study ID Numbers: 113978
Study First Received: July 27, 2010
Results First Received: February 28, 2017
Last Updated: April 12, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
booster vaccination
combined vaccine

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Poliomyelitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017