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Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106092
First Posted: April 19, 2010
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

Condition Intervention Phase
Haemophilus Influenzae Type b Tetanus Hepatitis B Whole Cell Pertussis Diphtheria Biological: GSK2036874A vaccine Biological: Zilbrix™/Hib vaccine Biological: Poliorix™ Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: One month after booster vaccination (At Month 1) ]
    Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

  • Anti-polio Types 1, 2 and 3 [ Time Frame: Prior to booster vaccination (At Month 0) ]
    Antibody titers were presented as geometric mean titers (GMTs).

  • Anti-polio Types 1, 2 and 3 [ Time Frame: One month after booster vaccination (At Month 1) ]
    Antibody titers were presented as geometric mean titers (GMTs).


Secondary Outcome Measures:
  • Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 [ Time Frame: One month after booster vaccination (At Month 1) ]
    Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).

  • Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: Prior to booster vaccination (At Month 0) ]
    Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.

  • Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]
    Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).

  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

  • Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) [ Time Frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1) ]
    Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.

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

  • Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]
    Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).

  • Anti-PRP Antibody Concentrations [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.

  • Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) [ Time Frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1) ]
    Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  • Anti-BPT Antibody Concentrations [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  • Number of Subjects With a Booster Response for Anti-BPT [ Time Frame: One month after booster vaccination (At Month 1) ]
    Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.

  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-Day 30) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 to Month 1) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 312
Study Start Date: May 1, 2010
Study Completion Date: September 2, 2010
Primary Completion Date: September 2, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2036874A GROUP 1
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Biological: GSK2036874A vaccine
Intramuscular, single dose
Experimental: GSK2036874A GROUP 2
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Biological: GSK2036874A vaccine
Intramuscular, single dose
Experimental: GSK2036874A GROUP 3
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Biological: GSK2036874A vaccine
Intramuscular, single dose
Active Comparator: ZILBRIX/HIB/POLIORIX GROUP
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Biological: Zilbrix™/Hib vaccine
Intramuscular, single dose
Biological: Poliorix™
Intramuscular, single dose

Detailed Description:
The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
  • Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
  • 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:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster 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 dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of neurologic disorders or seizures.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Child in care.
  • Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:

    • encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
    • fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
    • collapse or shock-like state within 48 hours of vaccination,
    • convulsions with or without fever, occurring within 3 days of vaccination.
  • 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.
  • Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106092


Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113264
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: 113264
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: 113264
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: 113264
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113264
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113264
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113264
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01106092     History of Changes
Other Study ID Numbers: 113264
First Submitted: April 1, 2010
First Posted: April 19, 2010
Results First Submitted: March 1, 2017
Results First Posted: April 12, 2017
Last Update Posted: May 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs