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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01439360
First received: September 21, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Influenza
Biological: Influenza vaccine GSK2321138A
Biological: Havrix Junior
Biological: Prevenar 13
Biological: Varivax/ProVarivax
Biological: Varilrix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12000
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLU D-QIV group
Subjects will receive the candidate influenza vaccine GSK2321138A.
Biological: Influenza vaccine GSK2321138A
Intramuscular injection
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).
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

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01439360

  Show 103 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01439360     History of Changes
Other Study ID Numbers: 115345, 2011-000758-41
Study First Received: September 21, 2011
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Agence Federale des Medicaments et des produits de sante

Keywords provided by GlaxoSmithKline:
Vaccine
Seasonal Flu
Efficacy
Children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014