Last updated: 11/07/2018 09:12:01
An efficacy study of GlaxoSmithKline (GSK) Biologicals’ candidate influenza vaccine GSK2321138A in children
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An efficacy study of GSK Biologicals’ quadrivalent influenza vaccine GSK2321138A (FLU D-QIV) when administered in children
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with moderate to severe RT-PCR confirmed influenza.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with RT-PCR confirmed influenza of any severity.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Secondary outcomes:
Number of subjects with first occurrence of lower respiratory illness (LRI) with RT-PCR confirmed influenza.
Timeframe: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to antigenically-matching influenza strains.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to antigenically-matching influenza strains
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of acute otitis media (AOM) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain.
Timeframe: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Number of subjects with first occurrence of RT-PCR confirmed severe influenza A and/or B due to any seasonal influenza strain.
Timeframe: During the surveillance period (approximately 6 to 8 months)
Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against each of four vaccine strains contained in the D-QIV (in immuno subcohort of subjects only)
Timeframe: At Days 0 and 28/56
Number of seropositive subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
Timeframe: At Day 0 and Day 28/56
Number of seroconverted subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
Timeframe: At Day 28/56 (POST)
Mean geometric increase (MGI) for HI antibody titer against each of the 4 vaccine influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only).
Timeframe: At Day 28/56 (POST)
Number of seroprotected subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
Timeframe: At Day 0 and Day 28/56
Number of subjects reporting any and grade 3 solicited local symptoms.
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Number of subjects reporting any, grade 3 and related solicited general symptoms.
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Duration of solicited local symptoms
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Duration of solicited general symptoms
Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 28-day (Days 0-27) post-vaccination period
Number of subjects reporting any, grade 3 and related AEs with medically attended visits (MAVs)
Timeframe: During the entire study period (approximately 6- 8 months per subject)
Number of subjects reporting any, grade 3 and related potential immune-mediated diseases (pIMDs).
Timeframe: During the entire study period (approximately 6- 8 months per subject)
Number of subjects reporting any and related serious adverse events (SAEs).
Timeframe: During the entire study period (approximately 6- 8 months per subject)
Interventions:
Biological/vaccine: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
Biological/vaccine: Havrix Junior
Biological/vaccine: Prevenar 13
Biological/vaccine: Varivax/ProVarivax
Biological/vaccine: Varilrix
Enrollment:
12046
Observational study model:
Not applicable
Primary completion date:
2014-31-10
Time perspective:
Not applicable
Clinical publications:
Claeys C et al. (2018) Prevention of vaccine-matched and mismatched influenza in children aged 6–35 months: a multinational randomised trial across five influenza seasons. The Lancet Child Adol. 2(5):338-349.
Medical condition
Influenza
Product
GSK2321138A
Collaborators
Not applicable
Study date(s)
October 2011 to December 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 35 months
Accepts healthy volunteers
Yes
- 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.
- Participation in a previous FLU-D-QIV-004 study (115345) cohort.
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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.
- 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.
Participation in a previous FLU-D-QIV-004 study (115345) cohort.
Any history of hepatitis A or varicella diseases.
Trial location(s)
Location
GSK Investigational Site
Westminster Bridge Road, United Kingdom, SE1 7EH
Status
Study Complete
Location
GSK Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU
Status
Study Complete
Location
GSK Investigational Site
Lipnik nad Becvou, Czech Republic, 75131
Status
Study Complete
Location
GSK Investigational Site
Crumpsall, Manchester, United Kingdom, M8 9JT
Status
Study Complete
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 37701
Status
Study Complete
Location
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
Status
Study Complete
Location
GSK Investigational Site
Yeovil, Somerset, United Kingdom, BA21 4AT
Status
Study Complete
Location
GSK Investigational Site
Santo Domingo, Distrito Nacional, Dominican Republic
Status
Study Complete
Location
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV6 4DD
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70800
Status
Study Complete
Location
GSK Investigational Site
Taunton, Somerset, United Kingdom, TA1 5DA
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28224
Status
Study Complete
Location
GSK Investigational Site
Bolton, Nr Manchester, United Kingdom, BL3 6TL
Status
Study Complete
Location
GSK Investigational Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
Status
Study Complete
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
Status
Study Complete
Location
GSK Investigational Site
Quart de Poblet, Valencia, Spain, 46930
Status
Study Complete
Location
GSK Investigational Site
St Austell, Cornwall, United Kingdom, PL26 7RL
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-31-10
Actual study completion date
2014-31-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
IPD for this study will be made available via the Clinical Study Data Request site.
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