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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

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ClinicalTrials.gov Identifier: NCT00964158
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE August 24, 2009
Results First Submitted Date  ICMJE July 31, 2017
Results First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Study Start Date  ICMJE September 10, 2009
Actual Primary Completion Date November 27, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value [ Time Frame: At Day 0 ]
    The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Day 42 ]
    The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
  • Titers for Serum HI Antibodies [ Time Frame: At Day 0 ]
    Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
  • Titers for Serum HI Antibodies [ Time Frame: At Day 42 ]
    Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
  • Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies [ Time Frame: At Day 42 ]
    A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
  • Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies [ Time Frame: At Day 42 ]
    Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
  • Seroconversion Factor (SCF) for HI Antibody Titers [ Time Frame: At Day 42 ]
    Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: Day 42 and Month 6+7 Days ]
Change History Complete list of historical versions of study NCT00964158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0, 21, 42 and at Month 12 ]
    The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
  • Titers for Serum HI Antibodies [ Time Frame: At Days 0, 21, 42 and at Month 12 ]
    Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
  • Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies [ Time Frame: At Days 21, 42 and at Month 12 ]
    A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
  • Number of Seroprotected Subjects in Terms of HI Antibodies [ Time Frame: At Days 0, 21, 42 and at Month 12 ]
    Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
  • Seroconversion Factor (SCF) for HI Antibody Titers [ Time Frame: At Days 21, 42 and at Month 12 ]
    Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0, 21 and 42 ]
    The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
  • Titers for Serum Neutralizing Antibodies [ Time Frame: At Days 0, 21 and 42 ]
    Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Month 12 ]
    The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
  • Titers for Serum Neutralizing Antibodies [ Time Frame: At Month 12 ]
    Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
  • Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies [ Time Frame: At Days 21 and 42 ]
    A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
  • Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies [ Time Frame: At Month 12 ]
    A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
  • 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 = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. 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 diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as 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 arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects With Any Medically-attended Events (MAEs) [ Time Frame: During the entire study period (from Day 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 Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs) [ Time Frame: During the entire study period (from Day 0 up to Month 12) ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
  • Number of Subjects With Normal or Abnormal Biochemical Levels [ Time Frame: At Days 0, 21 and 42 ]
    Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 21-day (Days 0-20) follow-up period after the first vaccination ]
    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 Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination ]
    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 Day 0 up 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
  • Humoral immune response in terms of H1N1 HI antibodies [ Time Frame: Day 0, 21, 42, Month 6, Month 6+7 Days, Month 12 and Month 18 ]
  • Humoral immune response in terms of neutralizing antibodies [ Time Frame: Day 0, 21, 42, Month 6, Month 6+7 Days, Month 12 and Month 18 ]
  • Occurrence of local and general symptoms [ Time Frame: During a 7-day follow-up period after each vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During a 21-day follow-up period after the first vaccination, during a 62-day follow-up period after the second vaccination, and during a 30 day follow up period after the booster vaccination ]
  • Occurrence of adverse events of specific interest, of serious adverse events, and of medically attended visits [ Time Frame: From the beginning up to the study end ]
  • Safety evaluation in terms of biochemical parameters [ Time Frame: Day 0, 21, 42, Month 6 and Month 6 + 7 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Official Title  ICMJE Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
Brief Summary This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection
Study Arms  ICMJE Experimental: Group A
Intervention: Biological: Pandemic influenza vaccine GSK2340272A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2010)
210
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2009)
200
Actual Study Completion Date  ICMJE November 27, 2010
Actual Primary Completion Date November 27, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into the study.
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.

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.
  • 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.
  • Acute disease and/or fever at the time of enrolment
  • 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.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
  • Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • Child in Care.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964158
Other Study ID Numbers  ICMJE 113528
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP