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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01323946




Registration number
NCT01323946
Ethics application status
Date submitted
24/03/2011
Date registered
28/03/2011

Titles & IDs
Public title
Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children
Scientific title
Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months
Secondary ID [1] 0 0
2011-004734-33
Secondary ID [2] 0 0
109825
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK Biologicals' investigational vaccine GSK1562902A

Experimental: GSK1562902A 6 to 12 M Group - Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Experimental: GSK1562902A 12 to 24 M Group - Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Experimental: GSK1562902A 24 to 36 M Group - Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.


Treatment: Other: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [1] 0 0
At Day 192
Primary outcome [2] 0 0
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Timepoint [2] 0 0
At Day 192
Primary outcome [3] 0 0
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Timepoint [3] 0 0
At Day 192
Secondary outcome [1] 0 0
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
Timepoint [1] 0 0
At Day 0, Day 42, Day 182, Day 192 and Day 364
Secondary outcome [2] 0 0
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Timepoint [2] 0 0
At Day 0, Day 182, Day 192 and Day 364
Secondary outcome [3] 0 0
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
Timepoint [3] 0 0
At Day 0, Day 42, Day 182, Day 192 and Day 364
Secondary outcome [4] 0 0
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [4] 0 0
At Day 0, Day 182, Day 192 and Day 364
Secondary outcome [5] 0 0
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Timepoint [5] 0 0
At Day 42, Day 182, Day 192 and Day 364
Secondary outcome [6] 0 0
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [6] 0 0
At Day 182 and Day 364
Secondary outcome [7] 0 0
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
Timepoint [7] 0 0
At Day 0, Day 42, Day 182, Day 192 and Day 364
Secondary outcome [8] 0 0
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [8] 0 0
Day 0, Day 182 and Day 364
Secondary outcome [9] 0 0
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Timepoint [9] 0 0
At Day 42, Day 182, Day 192 and Day 364
Secondary outcome [10] 0 0
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Timepoint [10] 0 0
Day 182 and Day 364
Secondary outcome [11] 0 0
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [11] 0 0
At Day 192 and Day 364
Secondary outcome [12] 0 0
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [12] 0 0
At Day 192 and Day 364
Secondary outcome [13] 0 0
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Timepoint [13] 0 0
Day 0, Day 42, Day 182, Day 192 and Day 364
Secondary outcome [14] 0 0
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [14] 0 0
Day 0, Day 182, Day 192 and Day 364
Secondary outcome [15] 0 0
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Timepoint [15] 0 0
Day 0, Day 42, Day 182, Day 192 and Day 364
Secondary outcome [16] 0 0
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [16] 0 0
Day 0, Day 182, Day 192 and Day 364
Secondary outcome [17] 0 0
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Timepoint [17] 0 0
At Day 42, Day 182, Day 192 and Day 364
Secondary outcome [18] 0 0
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [18] 0 0
At Day 182, Day 192 and Day 364
Secondary outcome [19] 0 0
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Timepoint [19] 0 0
At Day 192 and Day 364
Secondary outcome [20] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timepoint [20] 0 0
During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Secondary outcome [21] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Timepoint [21] 0 0
During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189)
Secondary outcome [22] 0 0
Number of Subjects With Medically-attended Events (MAEs)
Timepoint [22] 0 0
During the entire study period (from Day 0 to Day 364)
Secondary outcome [23] 0 0
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Timepoint [23] 0 0
During the entire study period (from day 0 to Day 364)
Secondary outcome [24] 0 0
Number of Subjects With Unsolicited Adverse Events (AEs)
Timepoint [24] 0 0
During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203)
Secondary outcome [25] 0 0
Number of Subjects With Unsolicited Adverse Events (AEs)
Timepoint [25] 0 0
During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266)
Secondary outcome [26] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [26] 0 0
During the entire study period (from Day 0 to 364)

Eligibility
Key inclusion criteria
* Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) 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 first study vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy children as established by medical history and clinical examination before entering the study.
* Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
* Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
Minimum age
6 Months
Maximum age
35 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any neurological disorders or seizures.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
* Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
* Child in care.
* Previous vaccination at any time with an H5N1 vaccine.
* Medical history of physician-confirmed infection with a H5N1 virus.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2012
Sample size
Target
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01323946