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Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01014091
First received: November 12, 2009
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Condition Intervention Phase
Influenza Biological: GSK pandemic vaccine GSK2340272A Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen [ Time Frame: At Day 42 ]
    Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).

  • Number of Seropositive Subjects for HI Antibodies [ Time Frame: At Day 42 ]
    A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.

  • Number of Seroconverted Subjects in Terms of HI Antibodies [ Time Frame: At Day 42 ]
    Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.

  • Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 42 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.

  • Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer [ Time Frame: At Day 42 ]
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.


Secondary Outcome Measures:
  • Number of Seropositive Subjects for HI Antibodies [ Time Frame: At Day 0, Day 21 and Month 7 ]
    A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.

  • HI Antibody Titers Against Vaccine H1N1 Antigen [ Time Frame: At Day 0, Day 21 and Month 7 ]
    Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).

  • Number of Seroconverted Subjects in Terms of HI Antibodies [ Time Frame: At Day 21 and Month 7 ]
    Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below < 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.

  • Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 0, Day 21 and Month 7 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.

  • Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer [ Time Frame: At Day 21 and Month 7 ]
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    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 = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever > 39.0 °C.

  • Number of Subjects With Any Medically-attended Events (MAEs) [ Time Frame: During the entire study period (from Month 0 up to Month 12) ]
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs) [ Time Frame: During the entire study period (from Month 0 up to Month 12) ]
    Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within the 42-day (Days 0-41) 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 to Month 12) ]
    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: 60
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2340272A F1 Y3-5 GROUP
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: GSK2340272A F1 Y6-9 GROUP
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: GSK2340272A F2 Y3-5 GROUP
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: GSK2340272A F2 Y6-9 GROUP
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: GSK2340272A F3 Y3-5 GROUP
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: GSK2340272A F3 Y6-9 GROUP
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
  • Written informed consent obtained from the parent(s) or LAR(s) of the subject.
  • Healthy children, as established by medical history and clinical examination when entering the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Have received any seasonal flu vaccine since last year.
  • Previous administration of any H1N1 A/California-like vaccine
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • 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°C on rectal setting.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
  • Child in Care.
  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: NCT01014091

Locations
Czech Republic
GSK Investigational Site
Decin, Czech Republic, 405 01
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Praha 6, Czech Republic, 1600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113810
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: 113810
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: 113810
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: 113810
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: 113810
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: 113810
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113810
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01014091     History of Changes
Other Study ID Numbers: 113810
Study First Received: November 12, 2009
Results First Received: March 7, 2017
Last Updated: March 21, 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:
influenza infection
GSK Bio's influenza vaccine GSK2340272A

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017