An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

This study is currently recruiting participants.
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01439360
First received: September 21, 2011
Last updated: April 10, 2014
Last verified: April 2014

September 21, 2011
April 10, 2014
October 2011
January 2015   (final data collection date for primary outcome measure)
  • First occurrence of Reverse transcription polymerase chain reaction (RT-PCR) confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of RT-PCR confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
First occurrence of RT-PCR confirmed influenza A and/or B disease due to any influenza strain [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01439360 on ClinicalTrials.gov Archive Site
  • First occurrence of Lower respiratory illness (LRI) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain identified at any time starting 7 days before the onset of LRI and ending 7 days after end of LRI [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to antigenically-matching influenza strains [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of culture-confirmed influenza A and/or B disease of any severity due to antigenically-matching influenza strains [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of culture-confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of acute otitis media (AOM) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain identified at any time starting 7 days before the onset of AOM and ending 7 days after end of AOM [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of RT-PCR confirmed severe influenza A and/or B due to any seasonal influenza strain [ Time Frame: During the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against each of four vaccine strains contained in the FLU D-QIV (in immuno subcohort of subjects only) [ Time Frame: At Days 0 and 28/56 ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: 7 days (Day 0-Day 6) after each vaccination ] [ Designated as safety issue: No ]
  • Unsolicited adverse events (AEs) [ Time Frame: 28 days (Day 0-Day 27) after each vaccination ] [ Designated as safety issue: No ]
  • AEs with medically attended visits (MAV) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
  • Serious Adverse events (SAEs) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
  • Potential Immune-Mediated-Diseases (pIMDs) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of culture-confirmed influenza A and/or B disease as defined in the primary outcome measure due to antigenically-matching influenza strains [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of culture-confirmed influenza A and/or B disease as defined in the primary outcome measure due to any influenza strains [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of RT-PCR confirmed moderate to severe influenza A and/or B [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of AOM with RT-PCR confirmed influenza A and/or B infection due to any influenza strain identified at any time starting 7 days before the onset of AOM and ending 7 days after end of AOM [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of LRI with RT-PCR confirmed influenza A and/or B infection due to any influenza strain identified at any time starting 7 days before the onset of LRI and ending 7 days after end of LRI [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • First occurrence of RT-PCR confirmed severe influenza A and/or B [ Time Frame: during the surveillance period (approximately 6 to 8 months) ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against vaccine strains contained in the influenza candidate vaccine (in immuno subcohort of subjects only) [ Time Frame: at Days 0 and 28/56 ] [ Designated as safety issue: No ]
  • Occurence of Solicited local and general symptoms [ Time Frame: 7 days (Day 0-Day 6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurence of unsolicited adverse events (AEs) [ Time Frame: 28 days (Day 0-Day 27) after each vaccination ] [ Designated as safety issue: No ]
  • Occurence of AEs with medically attended visits (MAV) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
  • Occurence of SAEs [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
  • Occurence of immune-Mediated-Diseases (pIMDs) [ Time Frame: Entire study period (6 to 8 months) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Influenza vaccine GSK2321138A
    Intramuscular injection
  • Biological: Havrix Junior
    Intramuscular injection administered to subjects aged 12 months or older
  • Biological: Prevenar 13
    Intramuscular injection administered to subjects less than 12 months of age
  • Biological: Varivax/ProVarivax
    Intramuscular injection administered to subjects more than 12 months of age
  • Biological: Varilrix
    Subcutaneous injection administered to subjects more than 12 months of age
  • Experimental: FLU D-QIV group
    Subjects will receive the candidate influenza vaccine GSK2321138A.
    Intervention: Biological: Influenza vaccine GSK2321138A
  • Active Comparator: Control group
    In function of their age and Flu-vaccine status, subjects will receive Prevenar 13 or Havrix Junior and possibly a varicella vaccine (Varilrix or Varivax/ProVarivax).
    Interventions:
    • Biological: Havrix Junior
    • Biological: Prevenar 13
    • Biological: Varivax/ProVarivax
    • Biological: Varilrix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12000
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination.
  • Written informed consent obtained from the parent(s) /LAR(s) of the subject.
  • Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Participation in a previous FLU-D-QIV-004 study (115345) cohort.
  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
  • Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination.
  • Any contraindication to intramuscular injection.
  • Acute disease and/or fever at the time of enrolment.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
  • Additional criteria for children ≥ 12 months of age:

    • Prior receipt of any licensed varicella vaccine* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted.

      * For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination.

    • Any history of hepatitis A or varicella diseases.
  • Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine:

    • Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
Both
6 Months to 35 Months
Yes
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Bangladesh,   Belgium,   Czech Republic,   Dominican Republic,   Honduras,   Lebanon,   Philippines,   Poland,   Spain,   Thailand,   Turkey,   United Kingdom
 
NCT01439360
115345, 2011-000758-41
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2014

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