TetanusPhase 2NCT00871741
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
A Phase 2 study testing GSK2202083A vaccine, Infanrix hexa and Menjugate in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 8 sites in Slovakia.
Trial summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age. Read more about this study
- Who is it for?
- Ages 8 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Poliomyelitis, Neisseria Meningitidis
- What is being tested?
- GSK2202083A vaccine, Infanrix hexa and Menjugate
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesSlovakia
- Study dates
- 1 Apr 2009to 25 Jun 2009
- 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 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
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- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Slovakia8 sites
GSK Investigational Site
Bratislava, 841 08
GSK Investigational Site
Bratislava, 851 05
GSK Investigational Site
Dolný Kubín, 026 01
GSK Investigational Site
Dunajská Streda, 929 01
GSK Investigational Site
Nové Zámky, 940 01
GSK Investigational Site
Ružomberok, 034 01
GSK Investigational Site
Štúrovo, 943 01
GSK Investigational Site
Trnava, 917 01
About this study
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b, Diphtheria, Acellular Pertussis
- Being tested
- GSK2202083A vaccine, Infanrix hexa, Menjugate
- Keywords
- Combined vaccine, Primary vaccination
- Medical subject headings
- Tetanus, Poliomyelitis, Haemophilus Infections, Diphtheria, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2202083A vaccineBiological
Intramuscular, three doses
Infanrix hexaBiological
Intramuscular, three doses
MenjugateBiological
Intramuscular, two doses
| Study group | Role | What they receive |
|---|---|---|
| GSK2202083A GROUP | Experimental | Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. Receives: Biological: GSK2202083A vaccine |
| INFANRIX + MENJUGATE GROUP | Active comparator | Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. Receives: Biological: Infanrix hexa; Biological: Menjugate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Measured: At Month 3
Secondary outcomes (4)
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Measured: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature.
Any = any general symptom irrespective of intensity grade and relationship to vaccination.
Grade 3 Irritability = crying that could not be comforted/prevented normal activity.
Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination.
Subjects from Control Group did not receive the second study vaccination dose due to study termination.
Measured: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events AE(s)
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: During the 31-day (Days 0-30) post-vaccination period
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: During the entire study period (from Month 0 to Month 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study start1 Apr 2009
- Primary completion25 Jun 2009
- Study completion25 Jun 2009
Why it stopped: Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to 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 TetanusStudies 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
- 16 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
- NCT00871741
- Sponsor's protocol ID
- 111761
- Status last verified
- Apr 2017
- First submitted
- 26 Mar 2009
- Last updated
- 6 Jun 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 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
- ClinicalTrials.gov ID
- NCT00871741
- Acronym / sponsor ID
- 111761
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b, Diphtheria, Acellular Pertussis
- Keywords
- Combined vaccine, Primary vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2009
- Primary completion
- 25 Jun 2009 (actual)
- Study completion
- 25 Jun 2009 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2202083A GROUP | Experimental | Biological: GSK2202083A vaccineSubjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
| INFANRIX + MENJUGATE GROUP | Active comparator | Biological: Infanrix hexa, Biological: MenjugateSubjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh. |
Who may qualify
- Ages
- 8 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
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 |
|---|---|---|
| GSK2202083A vaccineIntramuscular, three doses | Biological | GSK2202083A GROUP |
| Infanrix hexaIntramuscular, three doses | Biological | INFANRIX + MENJUGATE GROUP |
| MenjugateIntramuscular, two doses | Biological | INFANRIX + MENJUGATE GROUP |
Primary outcome
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL
Time frame: At Month 3
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
4 secondary outcomes
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events AE(s)
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 to Month 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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
8 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 GSK2202083A vaccine, Infanrix hexa and Menjugate in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 8 sites in Slovakia.
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 5 inclusion and 12 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Slovakia. 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 4 Apr 2017). 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?
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL (time frame: At Month 3). 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 6 Jun 2018.