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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01051661




Registration number
NCT01051661
Ethics application status
Date submitted
14/01/2010
Date registered
18/01/2010

Titles & IDs
Public title
Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
Scientific title
A Study to Evaluate the Safety and Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children Aged 6 Months to Less Than 10 Years of Age
Secondary ID [1] 0 0
114000
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 GSK2340274A (alternative formulations)
Treatment: Other - GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)
Treatment: Other - Placebo

Experimental: Arepanrix 2D 6M-3Y Group - Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Experimental: Arepanrix 2D 3Y-10Y Group - Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Experimental: Arepanrix 1D 6M-3Y Group - Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Experimental: Arepanrix 1D 3Y-10Y Group - Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Experimental: GSK2340273A 6M-3Y Group - Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Experimental: GSK2340273A 3Y-10Y Group - Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).


Treatment: Other: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)
Intramuscular injection, one or two doses

Treatment: Other: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)
Intramuscular injection, two doses

Treatment: Other: Placebo
Intramuscular injection, one dose
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Reporting at Least One A/California Influenza Event
Timepoint [1] 0 0
From 14 days after first vaccination until study conclusion on Day 385
Secondary outcome [1] 0 0
Number of Subjects Reporting at Least One A/California Influenza Event
Timepoint [1] 0 0
From 42 days after first vaccination until study conclusion on Day 385
Secondary outcome [2] 0 0
Number of Subjects Reporting at Least One A/California Influenza Event
Timepoint [2] 0 0
From Day 0 until study conclusion on Day 385
Secondary outcome [3] 0 0
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
Timepoint [3] 0 0
From 14 days after first vaccination until study conclusion on Day 385
Secondary outcome [4] 0 0
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
Timepoint [4] 0 0
From 42 days after first vaccination until study conclusion on Day 385
Secondary outcome [5] 0 0
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
Timepoint [5] 0 0
From Day 0 until study conclusion on Day 385
Secondary outcome [6] 0 0
Number of Subjects With at Least One Pneumonia Event
Timepoint [6] 0 0
From 14 days after first vaccination until study conclusion on Day 385
Secondary outcome [7] 0 0
Number of Subjects With at Least One Pneumonia Event
Timepoint [7] 0 0
From 42 days after first vaccination until study conclusion on Day 385
Secondary outcome [8] 0 0
Number of Subjects With at Least One Pneumonia Event
Timepoint [8] 0 0
From Day 0 after first vaccination until study conclusion on Day 385
Secondary outcome [9] 0 0
Number of Subjects With at Least One Pneumonia Event
Timepoint [9] 0 0
From 14 days after first vaccination until study conclusion at Day 385
Secondary outcome [10] 0 0
Number of Subjects With at Least One Pneumonia Event
Timepoint [10] 0 0
From 42 days after first vaccination until study conclusion at Day 385
Secondary outcome [11] 0 0
Number of Subjects With at Least One Pneumonia Event
Timepoint [11] 0 0
From Day 0 after first vaccination until study conclusion at Day 385
Secondary outcome [12] 0 0
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Timepoint [12] 0 0
From Day 0 until study end at Day 385
Secondary outcome [13] 0 0
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Timepoint [13] 0 0
From Day 14 until study end at Day 385
Secondary outcome [14] 0 0
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Timepoint [14] 0 0
From Day 0 until study end at Day 385
Secondary outcome [15] 0 0
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Timepoint [15] 0 0
From Day 14 until study end at Day 385
Secondary outcome [16] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timepoint [16] 0 0
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Secondary outcome [17] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years
Timepoint [17] 0 0
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Secondary outcome [18] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years
Timepoint [18] 0 0
During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Secondary outcome [19] 0 0
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Timepoint [19] 0 0
Up to Day 385
Secondary outcome [20] 0 0
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Timepoint [20] 0 0
Up to Day 385
Secondary outcome [21] 0 0
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Timepoint [21] 0 0
From Day 0 to Day 42
Secondary outcome [22] 0 0
Number of Subjects With Serious Adverse Events (SAEs)
Timepoint [22] 0 0
Up to Day 385
Secondary outcome [23] 0 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [23] 0 0
At Days 0 and 42
Secondary outcome [24] 0 0
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [24] 0 0
At Days 0 and 42
Secondary outcome [25] 0 0
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [25] 0 0
At Day 42
Secondary outcome [26] 0 0
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [26] 0 0
At Days 0 and 42
Secondary outcome [27] 0 0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [27] 0 0
At Day 42
Secondary outcome [28] 0 0
Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Timepoint [28] 0 0
At Day 42
Secondary outcome [29] 0 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Timepoint [29] 0 0
At Days 0 and 182
Secondary outcome [30] 0 0
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [30] 0 0
At Days 0 and 182
Secondary outcome [31] 0 0
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [31] 0 0
At Day 182
Secondary outcome [32] 0 0
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [32] 0 0
At Days 0 and 182
Secondary outcome [33] 0 0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [33] 0 0
At Day 182
Secondary outcome [34] 0 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [34] 0 0
At Days 0 and 385
Secondary outcome [35] 0 0
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [35] 0 0
At Days 0 and 385
Secondary outcome [36] 0 0
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [36] 0 0
At Day 385
Secondary outcome [37] 0 0
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [37] 0 0
At Days 0 and 385
Secondary outcome [38] 0 0
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Timepoint [38] 0 0
At Day 385

Eligibility
Key inclusion criteria
* Male or female children 6 months to less than 10 years of age at the time of the first vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of first vaccine dose under this protocol.
* Written informed consent obtained from the subject's parent(s)/legally acceptable representative(s) (LAR(s)); written informed assent obtained from the subject if appropriate pre local requirements).
* Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment.
* Parent(s)/LAR(s) available and accessible for active surveillance contacts.
* Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator's opinion, can and will comply with the requirements of the protocol as documented by signature on the informed consent document.
* Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.
Minimum age
6 Months
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine.
* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.
* Presence of a temperature = 38.0ºC (= 100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
* Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
* Administration of any licensed live attenuated vaccine within 4 weeks before the first vaccination or of any licensed inactivated vaccine within 2 weeks before the first vaccination.
* Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
* Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine other than the study vaccines during the study period.
* Planned administration of seasonal trivalent influenza vaccine during the 4 month period following Day 0.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days before the first dose of study vaccine, or planned use during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Child in care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
12/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2011
Sample size
Target
Accrual to date
Final
6154
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [2] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Santa Catarina
Country [2] 0 0
Brazil
State/province [2] 0 0
São Paulo
Country [3] 0 0
Colombia
State/province [3] 0 0
Cali
Country [4] 0 0
Costa Rica
State/province [4] 0 0
San Jose
Country [5] 0 0
Mexico
State/province [5] 0 0
Morelos
Country [6] 0 0
Mexico
State/province [6] 0 0
Durango
Country [7] 0 0
Mexico
State/province [7] 0 0
Mexico city
Country [8] 0 0
Mexico
State/province [8] 0 0
Monterrey
Country [9] 0 0
Philippines
State/province [9] 0 0
Dasmariñas, Cavite
Country [10] 0 0
Philippines
State/province [10] 0 0
Muntinlupa
Country [11] 0 0
Philippines
State/province [11] 0 0
Sampaloc, Manila
Country [12] 0 0
Singapore
State/province [12] 0 0
Singapore
Country [13] 0 0
Thailand
State/province [13] 0 0
Bangkok
Country [14] 0 0
Thailand
State/province [14] 0 0
Khon Kaen

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?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


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/NCT01051661