Last updated: 11/07/2018 05:51:30
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children
Trial description: This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroconverted subjects against 4 strains of influenza disease.
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Secondary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroconverted subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Number of seroconverted subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Number of seroprotected subjects against 4 strains of influenza disease
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Number of seroprotected subjects against 4 strains of influenza disease by age strata.
Timeframe: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Mean Geometric Increase (MGI) titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease by age strata.
Timeframe: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Number of subjects with any and grade 3 solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination.
Number of subjects with any, grade 3 and related solicited general symptoms in subjects younger than 6 years old.
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination.
Number of subjects with any, grade 3 and related solicited general symptoms in subjects aged 6 years or older.
Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination.
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).
Timeframe: During the 28-day (Days 0-27) follow-up period after any vaccination.
Number of subjects with any, grade 3 and related medically attended adverse events (MAEs).
Timeframe: During the entire study period (Day 0 - Day 180)
Number of subjects with any and related Potential Immune-Mediated Diseases (pIMDs).
Timeframe: During the entire study period (Day 0 - Day 180)
Number of subjects with any and related serious adverse events (SAEs).
Timeframe: During the entire study period (Day 0 - Day 180)
Number of days with solicited local symptoms.
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.
Number of days with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.
Interventions:
Enrollment:
3027
Primary completion date:
2011-15-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bekkat-Berkani R et al. (2016) Evidence update: GlaxoSmithKline’s inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 15(2):201-214.
Domachowske JB et al. (2013) A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3–17 years. J Infect Dis. 207(12):1878-1887.
Medical condition
Influenza
Product
GSK2321138A
Collaborators
Not applicable
Study date(s)
October 2010 to June 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 months - 17 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- For non US countries:
- 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. Routine registered childhood vaccinations are permitted.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
Inclusion and exclusion criteria
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.
- For non US countries:
- Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination. For US :
- 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.
- Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
- Written informed assent obtained from the subject if/as required by local regulations.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination,
- and has a negative urine pregnancy test on the day of vaccination,
- and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
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. Routine registered childhood vaccinations are permitted.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use during the study period.
- 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.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of seizures or progressive neurological disease.
- History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Concurrently participating in another clinical study, at any time during the study period in which the subject has been or will be exposed to an investigational or a non-investigational product .
- History of hypersensitivity to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
- Acute disease and/or fever at the time of enrolment
- Ongoing aspirin therapy
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study
- Child in Care.
Trial location(s)
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33432
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40509
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Study Complete
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 37701
Status
Study Complete
Location
GSK Investigational Site
San Angelo, Texas, United States, 76904
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02130
Status
Study Complete
Location
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
Status
Study Complete
Location
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Elmira, New York, United States, 14901
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42719
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Binghamton, New York, United States, 13901
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
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
Study complete
Actual primary completion date
2011-15-06
Actual study completion date
2011-15-06
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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