Last updated: 10/08/2020 18:30:12
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months
Trial description: The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Serum Haemagglutination-inhibition (HI) antibody titers
Timeframe: at Day 28/ Day 56
Serum neutralizing antibody titers
Timeframe: at Day 28/ Day 56
Geometric Mean number of all-CD4 cytokine positive cells
Timeframe: at Day 28/ Day 56
Number of subjects reporting fever of at least grade 2 or higher
Timeframe: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Secondary outcomes:
Serum HI antibody titers
Timeframe: on Days 0, 28/56 and 180
Serum neutralising antibody titers
Timeframe: on Days 0, 28/56 and 180
Number of subjects reporting solicited local and general symptoms
Timeframe: during a 7 day follow-up period (Day 0 to 6) after any vaccination
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: within 28 days (Day 0 to Day 27) after any vaccination
Number of subjects reporting adverse events with medically attended visits
Timeframe: From Day 0 to 179
Number of subjects reporting potential Immune-mediated diseases
Timeframe: From Day 0 to 179
Number of subjects reporting serious adverse events
Timeframe: From Day 0 to 179
Interventions:
Enrollment:
4
Primary completion date:
2011-22-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK2321138A, GSK2584786A, SB218352
Collaborators
Not applicable
Study date(s)
September 2010 to March 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
6 - 35 months
Accepts healthy volunteers
Yes
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in "care"
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
- Born after gestation period of 36 to 42 weeks inclusive
Exclusion criteria:
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in "care"
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of any influenza vaccination or planned administration during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- A family history of febrile seizures or/and epilepsy
- Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to any constituent of influenza vaccine.
- History of any progressive neurological disorders or seizures.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- Acute disease and/or fever at the time of enrolment:
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥38.0°C on rectal setting.
- Subjects with a minor illness without fever might be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
Trial location(s)
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
Other
Actual primary completion date
2011-22-03
Actual study completion date
2011-22-03
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
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website