InfluenzaPhase 2NCT01003418
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
A Phase 2 study testing GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Infanrix™-IPV/Hib and Prevenar in people with Influenza, run by GlaxoSmithKline at 4 sites in Norway.
Trial summary
The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination. Read more about this study
- Who is it for?
- Ages 8 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Infanrix™-IPV/Hib and Prevenar
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesNorway
- Study dates
- 17 Nov 2009to 25 Nov 2010
- Phase
- Phase 2
- 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 8 to 12 weeks
- 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 their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol
- Children, male or female, aged between 8 and 12 weeks 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 when entering the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Born after a gestation period of >= 36 to <= 42 weeks.
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:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- History of any neurological disorders or seizures.
- A family history of congenital or hereditary immunodeficiency.
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- Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
- Administration of any vaccines within two weeks before study enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
- Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
- History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
- Major congenital defects or serious chronic illness.
- Child in care.
- Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
GSK Investigational Site
Bergen, 5021
GSK Investigational Site
Hønefoss, N-3515
GSK Investigational Site
Lierskogen, 3420
GSK Investigational Site
Oslo, 0027
About this study
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 8 to 12 Weeks
The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.
- Conditions
- Influenza
- Being tested
- GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Infanrix™-IPV/Hib, Prevenar
- Keywords
- GSK2340272A, H1N1 pandemic influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2340272A GSK Biologicals' investigational influenza pandemic vaccineBiological
Two doses; intramuscular administration
Infanrix™-IPV/HibBiological
Routine infant immunisation vaccine, three doses administered intramuscularly
PrevenarBiological
Routine infant immunisation vaccine, three doses administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| GSK2340272A Group 1 | Experimental | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. Receives: Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine; Biological: Infanrix™-IPV/Hib; Biological: Prevenar |
| GSK2340272A Group 2 | Experimental | Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. Receives: Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine; Biological: Infanrix™-IPV/Hib; Biological: Prevenar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Any Solicited Local or General Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
Measured: During the 7-days post-Dose 1 period (Days 0-6)
Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.
Measured: During the 2-weeks post-Dose 1 period (Days 0-13)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: During the 2-weeks post-Dose 1 period (Days 0-13)
Secondary outcomes (3)
Number of Subjects With Any Solicited Local or General Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
Measured: During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
Number of Subjects With Any, Grade 3 and Related Unsolicited 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 AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination. Results about unsolicited AEs for this endpoint were based on individual listings.
Measured: During the 28-day (Days 0-27) follow-up period after each study vaccine administration
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Results about SAEs were based on individual listings.
Measured: During the entire study period (From Month 0 up to Month 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study start17 Nov 2009
- Primary completion25 Nov 2010
- Study completion25 Nov 2010
Why it stopped: The study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT01003418
- Sponsor's protocol ID
- 113629
- Status last verified
- Sep 2018
- First submitted
- 27 Oct 2009
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 8 to 12 Weeks
- ClinicalTrials.gov ID
- NCT01003418
- Acronym / sponsor ID
- 113629
- Conditions
- Influenza
- Keywords
- GSK2340272A, H1N1 pandemic influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely for logistic reasons, not related to safety or efficacy of the vaccine.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2009 (actual)
- Primary completion
- 25 Nov 2010 (actual)
- Study completion
- 25 Nov 2010 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 15 Feb 2019
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 assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2340272A Group 1 | Experimental | Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Biological: Infanrix™-IPV/Hib, Biological: PrevenarHealthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
| GSK2340272A Group 2 | Experimental | Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Biological: Infanrix™-IPV/Hib, Biological: PrevenarHealthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh. |
Who may qualify
- Ages
- 8 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol
- Children, male or female, aged between 8 and 12 weeks 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 when entering the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Key exclusion criteria (15 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:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- History of any neurological disorders or seizures.
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 |
|---|---|---|
| GSK2340272A GSK Biologicals' investigational influenza pandemic vaccineTwo doses; intramuscular administration | Biological | GSK2340272A Group 1, GSK2340272A Group 2 |
| Infanrix™-IPV/HibRoutine infant immunisation vaccine, three doses administered intramuscularly | Biological | GSK2340272A Group 1, GSK2340272A Group 2 |
| PrevenarRoutine infant immunisation vaccine, three doses administered intramuscularly | Biological | GSK2340272A Group 1, GSK2340272A Group 2 |
Primary outcome
Number of Subjects With Any Solicited Local or General Symptoms
Time frame: During the 7-days post-Dose 1 period (Days 0-6)
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 2-weeks post-Dose 1 period (Days 0-13)
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. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the 2-weeks post-Dose 1 period (Days 0-13)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
3 secondary outcomes
Number of Subjects With Any Solicited Local or General Symptoms
Time frame: During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
Time frame: During the 28-day (Days 0-27) follow-up period after each study vaccine administration
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (From Month 0 up to Month 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Infanrix™-IPV/Hib and Prevenar in people with Influenza, run by GlaxoSmithKline at 4 sites in Norway.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Feb 2019). 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 With Any Solicited Local or General Symptoms (time frame: During the 7-days post-Dose 1 period (Days 0-6)). The study lists 3 primary outcomes in all. 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 15 Feb 2019.