InfluenzaPhase 1NCT01096056
Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children
A Phase 1 study testing Influenza vaccine GSK2186877A formulation 1, Influenza vaccine GSK2186877A formulation 2 and Fluarix in people with Influenza, run by GlaxoSmithKline at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age. This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccine GSK2186877A formulation 1, Influenza vaccine GSK2186877A formulation 2 and Fluarix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2010to 13 Dec 2010
- Phase
- Phase 1
- 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 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 (drug or vaccine) 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 (seasonal or pandemic) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone >0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- A family history of congenital or hereditary immunodeficiency.
- 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 consumption of egg proteins.
- History of any neurological disorders or seizures (including febrile convulsion).
- 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 (such as mild diarrhoea, mild upper respiratory infection) 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of GSK2186877A Candidate Seasonal Influenza Vaccine in Healthy Children 6 to 35 Months of Age.
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.
This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.
- Conditions
- Influenza
- Being tested
- Influenza vaccine GSK2186877A formulation 1, Influenza vaccine GSK2186877A formulation 2, Fluarix
- Keywords
- Children, Influenza, Safety, Immunogenicity, Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccine GSK2186877A formulation 1Biological
Intramuscular administration, 2 doses
Influenza vaccine GSK2186877A formulation 2Biological
Intramuscular administration, 1 dose
FluarixBiological
Intramuscular administration, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine GSK2186877A formulation 1 Group | Experimental | Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6. Receives: Biological: Influenza vaccine GSK2186877A formulation 1; Biological: Fluarix |
| Influenza vaccine GSK2186877A formulation 2 Group | Experimental | Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6. Receives: Biological: Influenza vaccine GSK2186877A formulation 2; Biological: Fluarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Fever Grade 2 or Higher
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature >38 degree centigrade (°C).
Measured: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Secondary outcomes (13)
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Measured: At Day 0 and Day 42
The Number of Subjects Seropositive to HI Antibodies
A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Measured: At Day 0 and Day 42
The Number of Subjects Seroprotected to HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Measured: At Day 0 and Day 42
The Number of Subjects Seroconverted to HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Measured: Day 42
HI Antibody Geometric Mean Fold Rise (GMFR)
GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Measured: Day 42
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.
Measured: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.
Measured: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.
Measured: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Duration of Solicited General AEs
Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.
Measured: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.
Measured: Day 0 up to Month 7
Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Measured: Day 0 up to Month 7
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.
Measured: Day 0 up to Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study start5 Apr 2010
- Primary completion13 Dec 2010
- Study completion13 Dec 2010
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01096056
- Sponsor's protocol ID
- 114182
- Status last verified
- Sep 2016
- First submitted
- 29 Mar 2010
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of GSK2186877A Candidate Seasonal Influenza Vaccine in Healthy Children 6 to 35 Months of Age.
- ClinicalTrials.gov ID
- NCT01096056
- Acronym / sponsor ID
- 114182
- Conditions
- Influenza
- Keywords
- Children, Influenza, Safety, Immunogenicity, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2010
- Primary completion
- 13 Dec 2010 (actual)
- Study completion
- 13 Dec 2010 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Posted 10 May 2012
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 evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.
This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine GSK2186877A formulation 1 Group | Experimental | Biological: Influenza vaccine GSK2186877A formulation 1, Biological: FluarixSubjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6. |
| Influenza vaccine GSK2186877A formulation 2 Group | Experimental | Biological: Influenza vaccine GSK2186877A formulation 2, Biological: FluarixSubjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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 (drug or vaccine) 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 (seasonal or pandemic) or planned administration during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
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 |
|---|---|---|
| Influenza vaccine GSK2186877A formulation 1Intramuscular administration, 2 doses | Biological | Influenza vaccine GSK2186877A formulation 1 Group |
| Influenza vaccine GSK2186877A formulation 2Intramuscular administration, 1 dose | Biological | Influenza vaccine GSK2186877A formulation 2 Group |
| FluarixIntramuscular administration, 1 dose | Biological | Influenza vaccine GSK2186877A formulation 1 Group, Influenza vaccine GSK2186877A formulation 2 Group |
Primary outcome
Number of Subjects Reporting Fever Grade 2 or Higher
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature >38 degree centigrade (°C).
13 secondary outcomes
Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Day 0 and Day 42
The Number of Subjects Seropositive to HI Antibodies
Time frame: At Day 0 and Day 42
The Number of Subjects Seroprotected to HI Antibodies
Time frame: At Day 0 and Day 42
The Number of Subjects Seroconverted to HI Antibodies
Time frame: Day 42
HI Antibody Geometric Mean Fold Rise (GMFR)
Time frame: Day 42
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Duration of Solicited Local AEs
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Duration of Solicited General AEs
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
Time frame: Day 0 up to Month 7
Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)
Time frame: Day 0 up to Month 7
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: Day 0 up to Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza vaccine GSK2186877A formulation 1, Influenza vaccine GSK2186877A formulation 2 and Fluarix in people with Influenza, run by GlaxoSmithKline at 1 site in Spain.
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 16 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 May 2012). 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 Fever Grade 2 or Higher (time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2018.