InfluenzaPhase 3NCT01051661
Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
A Phase 3 study testing GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) and GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations) in people with Influenza, run by GlaxoSmithKline at 17 sites in 8 countries.
Trial summary
The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age. Read more about this study
- Who is it for?
- Ages 6 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) and GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,154 participants
- Where
- 17 sitesin 8 countries
- Study dates
- 12 Feb 2010to 9 Sep 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
Mexico4 sites
GSK Investigational Site
Cuernavaca, Morelos
GSK Investigational Site
Durango, 3400
GSK Investigational Site
Mexico City, 04530
GSK Investigational Site
Monterrey
Brazil3 sites
GSK Investigational Site
Florianópolis, Santa Catarina, 88025 300
GSK Investigational Site
São Paulo, 04038 001
GSK Investigational Site
São Paulo
Philippines3 sites
GSK Investigational Site
City of Muntinlupa, 1781
GSK Investigational Site
Dasmariñas, Cavite, 4114
GSK Investigational Site
Sampaloc, Manila, 1008
Australia2 sites
GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
Kippa-Ring, Queensland, 4021
Thailand2 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Khon Kaen, 40002
About this study
Official 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
The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.
- Conditions
- Influenza
- Being tested
- GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations), GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations), Placebo
- Keywords
- Influenza, H1N1, Pandemic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)Biological
Also called Arepanrix
Intramuscular injection, one or two doses
GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)Biological
Intramuscular injection, two doses
PlaceboBiological
Intramuscular injection, one dose
| Study group | Role | What they receive |
|---|---|---|
| Arepanrix 2D 6M-3Y Group | Experimental | 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. Receives: Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) |
| Arepanrix 2D 3Y-10Y Group | Experimental | 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). Receives: Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) |
| Arepanrix 1D 6M-3Y Group | Experimental | 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. Receives: Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations); Biological: Placebo |
| Arepanrix 1D 3Y-10Y Group | Experimental | 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). Receives: Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations); Biological: Placebo |
| GSK2340273A 6M-3Y Group | Experimental | 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. Receives: Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations) |
| GSK2340273A 3Y-10Y Group | Experimental | 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). Receives: Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting at Least One A/California Influenza Event
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Measured: From 14 days after first vaccination until study conclusion on Day 385
Secondary outcomes (38)
Number of Subjects Reporting at Least One A/California Influenza Event
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Measured: From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One A/California Influenza Event
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Measured: From Day 0 until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
Measured: From 14 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
Measured: From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
The influenza virus presence was confirmed by a positive culture.
Measured: From Day 0 until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Measured: From 14 days after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Measured: From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Measured: From Day 0 after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Measured: From 14 days after first vaccination until study conclusion at Day 385
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Measured: From 42 days after first vaccination until study conclusion at Day 385
Number of Subjects With at Least One Pneumonia Event
Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
Measured: From Day 0 after first vaccination until study conclusion at Day 385
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.
Measured: From Day 0 until study end at Day 385
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.
Measured: From Day 14 until study end at Day 385
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.
Measured: From Day 0 until study end at Day 385
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.
Measured: From Day 14 until study end at Day 385
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness which prevented normal everyday activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (gastro.sympt.), headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = Incidence of a particular symptom regardless of intensity grade or relationship to study vaccination. Grade 3 = symptom which prevented normal everyday activity. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: Up to Day 385
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: Up to Day 385
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: From Day 0 to Day 42
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Up to Day 385
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Titers are presented as geometric mean titers (GMTs).
Measured: At Days 0 and 42
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.
Measured: At Days 0 and 42
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Measured: At Day 42
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Days 0 and 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0.
Measured: At Day 42
Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
The geometric mean titer ratio (GMT ratio) was defined as the ratio of geometric mean of the post-vaccination reciprocal HI titer between groups. The analysis was not performed for Day 182 and Day 385 as planned per protocol.
Measured: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Titers are presented as geometric mean titers (GMTs).
Measured: At Days 0 and 182
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.
Measured: At Days 0 and 182
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Measured: At Day 182
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Days 0 and 182
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Measured: At Day 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Titers are presented as geometric mean titers (GMTs).
Measured: At Days 0 and 385
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seropositive subject was defined as a subject whose HI titers was greater than or equal to (≥) 1:10.
Measured: At Days 0 and 385
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Measured: At Day 385
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Days 0 and 385
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.
Measured: At Day 385
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study start12 Feb 2010
- Primary completion31 Aug 2011
- Study completion9 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051661
- Sponsor's protocol ID
- 114000
- Status last verified
- Feb 2021
- First submitted
- 14 Jan 2010
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Nolan T, Roy-Ghanta S, Montellano M, Weckx L, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Safadi MA, Cruz-Valdez A, Litao S, Lim FS, de Los Santos AM, Weber MA, Tinoco JC, Mezerville MH, Faingezicht I, Kosuwon P, Lopez P, Borja-Tabora C, Li P, Durviaux S, Fries L, Dubin G, Breuer T, Innis BL, Vaughn DW. Relative efficacy of AS03-adjuvanted pandemic influenza A(H1N1) vaccine in children: results of a controlled, randomized efficacy trial. J Infect Dis. 2014 Aug 15;210(4):545-57. doi: 10.1093/infdis/jiu173. Epub 2014 Mar 20.
PubMed 24652494Taylor S, Lopez P, Weckx L, Borja-Tabora C, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Angel Rodriguez Weber M, Mascarenas de Los Santos A, Tinoco JC, Safadi MA, Lim FS, Hernandez-de Mezerville M, Faingezicht I, Cruz-Valdez A, Feng Y, Li P, Durviaux S, Haars G, Roy-Ghanta S, Vaughn DW, Nolan T. Respiratory viruses and influenza-like illness: Epidemiology and outcomes in children aged 6 months to 10 years in a multi-country population sample. J Infect. 2017 Jan;74(1):29-41. doi: 10.1016/j.jinf.2016.09.003. Epub 2016 Sep 22.
PubMed 27667752
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01051661
- Acronym / sponsor ID
- 114000
- Conditions
- Influenza
- Keywords
- Influenza, H1N1, Pandemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,154 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2010 (actual)
- Primary completion
- 31 Aug 2011 (actual)
- Study completion
- 9 Sep 2011 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Posted 13 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arepanrix 2D 6M-3Y Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)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. |
| Arepanrix 2D 3Y-10Y Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)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). |
| Arepanrix 1D 6M-3Y Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations), Biological: PlaceboSubjects, 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. |
| Arepanrix 1D 3Y-10Y Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations), Biological: PlaceboSubjects, 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). |
| GSK2340273A 6M-3Y Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)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. |
| GSK2340273A 3Y-10Y Group | Experimental | Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)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). |
Who may qualify
- Ages
- 6 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)Also: ArepanrixIntramuscular injection, one or two doses | Biological | Arepanrix 1D 3Y-10Y Group, Arepanrix 1D 6M-3Y Group, Arepanrix 2D 3Y-10Y Group, Arepanrix 2D 6M-3Y Group |
| GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)Intramuscular injection, two doses | Biological | GSK2340273A 3Y-10Y Group, GSK2340273A 6M-3Y Group |
| PlaceboIntramuscular injection, one dose | Biological | Arepanrix 1D 3Y-10Y Group, Arepanrix 1D 6M-3Y Group |
Primary outcome
Number of Subjects Reporting at Least One A/California Influenza Event
Time frame: From 14 days after first vaccination until study conclusion on Day 385
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
38 secondary outcomes
Number of Subjects Reporting at Least One A/California Influenza Event
Time frame: From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One A/California Influenza Event
Time frame: From Day 0 until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
Time frame: From 14 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
Time frame: From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event
Time frame: From Day 0 until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Time frame: From 14 days after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Time frame: From 42 days after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Time frame: From Day 0 after first vaccination until study conclusion on Day 385
Number of Subjects With at Least One Pneumonia Event
Time frame: From 14 days after first vaccination until study conclusion at Day 385
Number of Subjects With at Least One Pneumonia Event
Time frame: From 42 days after first vaccination until study conclusion at Day 385
Number of Subjects With at Least One Pneumonia Event
Time frame: From Day 0 after first vaccination until study conclusion at Day 385
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Time frame: From Day 0 until study end at Day 385
Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases
Time frame: From Day 14 until study end at Day 385
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Time frame: From Day 0 until study end at Day 385
Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases
Time frame: From Day 14 until study end at Day 385
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years
Time frame: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years
Time frame: During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Time frame: Up to Day 385
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Time frame: Up to Day 385
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: From Day 0 to Day 42
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Up to Day 385
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 42
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 42
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Day 42
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Day 42
Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Time frame: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)
Time frame: At Days 0 and 182
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 182
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Day 182
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 182
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Day 182
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 385
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 385
Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Day 385
Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Days 0 and 385
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain
Time frame: At Day 385
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24652494Nolan T, Roy-Ghanta S, Montellano M, Weckx L, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Safadi MA, Cruz-Valdez A, Litao S, Lim FS, de Los Santos AM, Weber MA, Tinoco JC, Mezerville MH, Faingezicht I, Kosuwon P, Lopez P, Borja-Tabora C, Li P, Durviaux S, Fries L, Dubin G, Breuer T, Innis BL, Vaughn DW. Relative efficacy of AS03-adjuvanted pandemic influenza A(H1N1) vaccine in children: results of a controlled, randomized efficacy trial. J Infect Dis. 2014 Aug 15;210(4):545-57. doi: 10.1093/infdis/jiu173. Epub 2014 Mar 20.
- Derived from this study: PubMed 27667752Taylor S, Lopez P, Weckx L, Borja-Tabora C, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Angel Rodriguez Weber M, Mascarenas de Los Santos A, Tinoco JC, Safadi MA, Lim FS, Hernandez-de Mezerville M, Faingezicht I, Cruz-Valdez A, Feng Y, Li P, Durviaux S, Haars G, Roy-Ghanta S, Vaughn DW, Nolan T. Respiratory viruses and influenza-like illness: Epidemiology and outcomes in children aged 6 months to 10 years in a multi-country population sample. J Infect. 2017 Jan;74(1):29-41. doi: 10.1016/j.jinf.2016.09.003. Epub 2016 Sep 22.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) and GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations) in people with Influenza, run by GlaxoSmithKline at 17 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Mexico, Brazil, Philippines, Australia, Thailand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Reporting at Least One A/California Influenza Event (time frame: From 14 days after first vaccination until study conclusion on Day 385). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01051661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.