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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: October 2, 2014
Last verified: September 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

  Hide Study Locations
Locations
Bangladesh
GSK Investigational Site
Dhaka, Bangladesh, 1000
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2018
GSK Investigational Site
Antwerpen, Belgium, 2020
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Mechelen, Belgium, 2800
GSK Investigational Site
Namur, Belgium, 5000
GSK Investigational Site
Roeselaere, Belgium, 8800
GSK Investigational Site
Turnhout, Belgium, 2300
Czech Republic
GSK Investigational Site
Decin, Czech Republic, 405 01
GSK Investigational Site
Humpolec, Czech Republic, 396 01
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 37701
GSK Investigational Site
Liberec, Czech Republic, 46015
GSK Investigational Site
Lipnik nad Becvou, Czech Republic, 75131
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Odolena voda, Czech Republic, 25070
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70800
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Praha 6, Czech Republic, 1600
GSK Investigational Site
Tabor, Czech Republic, 390 02
Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
GSK Investigational Site
Santo Domingo, Distrito Nacional, Dominican Republic
Honduras
GSK Investigational Site
San Pedro Sula, Honduras
GSK Investigational Site
Tegucigalpa, Honduras
India
GSK Investigational Site
Faridabad, India, 121004
GSK Investigational Site
Pune, India
GSK Investigational Site
Pune, India, 411 011
Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Philippines
GSK Investigational Site
Manila, Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Metro Manila, Philippines, 1000
GSK Investigational Site
Muntinlupa, Philippines, 1781
GSK Investigational Site
Quezon City, Philippines, 1113
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-168
GSK Investigational Site
Bydgoszcz, Poland, 85-079
GSK Investigational Site
Bydgoszcz, Poland, 85-316
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Gdansk, Poland, 84-462
GSK Investigational Site
Grudziadz, Poland, 86-330
GSK Investigational Site
Katowice, Poland, 40-129
GSK Investigational Site
Katowice, Poland, 40-018
GSK Investigational Site
Krakow, Poland, 31-223
GSK Investigational Site
Leczna, Poland, 21-010
GSK Investigational Site
Lodz, Poland, 90-242
GSK Investigational Site
Lublin, Poland, 20-044
GSK Investigational Site
Oborniki, Poland, 55-120
GSK Investigational Site
Poznan, Poland, 61-709
GSK Investigational Site
Poznan, Poland, 62-064
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-103
GSK Investigational Site
Tarnow, Poland, 33-100
GSK Investigational Site
Torun, Poland
GSK Investigational Site
Warszawa, Poland, 00-315
GSK Investigational Site
Wola, Poland, 43-225
GSK Investigational Site
Wroclaw, Poland, 52-312
Spain
GSK Investigational Site
Antequera/Málaga, Spain, 29200
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08042
GSK Investigational Site
Blanes (Girona), Spain, 17300
GSK Investigational Site
Boabdilla del Monte, Spain, 28660
GSK Investigational Site
Castellón, Spain, 12004
GSK Investigational Site
Castellón, Spain, 12530
GSK Investigational Site
Centelles (Barcelona), Spain, 08540
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28700
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28224
GSK Investigational Site
Quart de Poblet, Valencia, Spain, 46930
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41014
GSK Investigational Site
Sevilla, Spain, 41927
GSK Investigational Site
Torrelodones (Madrid), Spain, 28250
GSK Investigational Site
Valencia, Spain, 46011
GSK Investigational Site
Valencia, Spain, 46200
GSK Investigational Site
Valencia, Spain, 46702
GSK Investigational Site
Valencia, Spain, 46024
GSK Investigational Site
Vic/ Barcelona, Spain, 08500
GSK Investigational Site
Xativa/Valencia, Spain, 46800
Thailand
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Khon Kaen, Thailand, 40002
Turkey
GSK Investigational Site
Bursa, Turkey
GSK Investigational Site
Eskisehir, Turkey
GSK Investigational Site
Istanbul, Turkey, 34890
United Kingdom
GSK Investigational Site
St Austell, Cornwall, United Kingdom, PL26 7RL
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
GSK Investigational Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
GSK Investigational Site
Yeovil, Somerset, United Kingdom, BA21 4AT
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV6 4DD
GSK Investigational Site
Belfast, United Kingdom, BT7 2EB
GSK Investigational Site
Bolton, Nr Manchester, United Kingdom, BL3 6TL
GSK Investigational Site
Bristol, United Kingdom, BS2 8AE
GSK Investigational Site
Co Antrim, United Kingdom, BT41 3AE
GSK Investigational Site
Crumpsall, Manchester, United Kingdom, M8 9JT
GSK Investigational Site
Exeter, United Kingdom, EX2 5DW
GSK Investigational Site
Gloucester, United Kingdom, GL1 3NN
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
GSK Investigational Site
Nottingham, United Kingdom, NG7 2QW
GSK Investigational Site
Oxford, United Kingdom, OX3 7LJ
GSK Investigational Site
Taunton, Somerset, United Kingdom, TA1 5DA
GSK Investigational Site
Westminster Bridge Road, United Kingdom, SE1 7EH
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: October 2, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Agence Federale des Medicaments et des produits de sante

Keywords provided by GlaxoSmithKline:
Efficacy
Children
Vaccine
Seasonal Flu

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

ClinicalTrials.gov processed this record on November 23, 2014