Infections, MeningococcalPhase 2NCT00661557
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
A Phase 2 study testing Meningococcal vaccine GSK134612 (Nimenrix) in people with Infections, Meningococcal, run by GlaxoSmithKline at 1 site in Lebanon.
Trial summary
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology. Read more about this study
- Who is it for?
- Ages 4 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612 (Nimenrix)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteLebanon
- Study dates
- 19 May 2008to 19 Dec 2008
- 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 4 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
- For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
- Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine.
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- For the MPS Group, vaccination against meningococcal disease after completion of study 102394
- For the noMPS group, previous vaccination, or vaccination within the last 10 years, against meningococcal disease (of any serogroup).
Show all 19Show fewer
- Previous vaccination against tetanus within 30 days.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical.
- A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Know hypersensitivity to any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active stage of the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 Administered in Healthy Subjects Either Previously Primed With Mencevax™ ACWY or naïve to Meningococcal Vaccination.
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.
These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
Read the detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups.
This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612 (Nimenrix)
- Keywords
- Booster vaccination, Meningococcal vaccine, Meningococcal disease, Safety, immunogenicity
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612 (Nimenrix)Biological
one dose, as intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Mencevax Primed Group | Experimental | Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. Receives: Biological: Meningococcal vaccine GSK134612 (Nimenrix) |
| Mencevax Naive Group | Active comparator | Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. Receives: Biological: Meningococcal vaccine GSK134612 (Nimenrix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Measured: One month post-vaccination (Month 1)
Secondary outcomes (9)
Meningococcal rSBA Titers
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Measured: Prior to vaccination (Day 0)
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs).
Measured: Prior to (Day 0) and one month post-vaccination (Month 1)
Anti-tetanus Toxoid Antibody Concentrations
Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs).
Measured: Prior to (Day 0) and one month post-vaccination (Month 1)
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
Vaccine response defined as:
For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer
Measured: One month post-vaccination (Month 1)
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 4-day (Day 0 to Day 3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Day 0 to Day 3) period after vaccination
Number of Subjects With Unsolicited Symptoms
An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination.
Measured: Up to one month post-vaccination (Month 1)
Number of Subjects Reporting Any Serious Adverse Events
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: Day 0 to study month 6
Number of Subjects With Any Specific Adverse Events
Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease).
Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately.
Measured: Day 0 to study month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study start19 May 2008
- Primary completion19 Dec 2008
- Study completion19 Dec 2008
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 Infections, MeningococcalStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 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
- NCT00661557
- Sponsor's protocol ID
- 107408
- Status last verified
- Jun 2018
- First submitted
- 14 Apr 2008
- Last updated
- 28 Dec 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.
Publications
Dbaibo G, Van der Wielen M, Reda M, Medlej F, Tabet C, Boutriau D, Sumbul A, Anis S, Miller JM. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine. Int J Infect Dis. 2012 Aug;16(8):e608-15. doi: 10.1016/j.ijid.2012.04.006. Epub 2012 Jun 14.
PubMed 22704725Dbaibo G et al. One dose of the meningococcal tetravalent tetanus toxoid conjugated vaccine (MenACWY-TT) is immunogenic with an acceptable safety profile in unvaccinated subjects and those previously vaccinated with a MenACWY polysaccharide vaccine. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 Administered in Healthy Subjects Either Previously Primed With Mencevax™ ACWY or naïve to Meningococcal Vaccination.
- ClinicalTrials.gov ID
- NCT00661557
- Acronym / sponsor ID
- 107408
- Conditions
- Infections, Meningococcal
- Keywords
- Booster vaccination, Meningococcal vaccine, Meningococcal disease, Safety, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 May 2008 (actual)
- Primary completion
- 19 Dec 2008 (actual)
- Study completion
- 19 Dec 2008 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 28 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.
These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
Detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups.
This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mencevax Primed Group | Experimental | Biological: Meningococcal vaccine GSK134612 (Nimenrix)Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Mencevax Naive Group | Active comparator | Biological: Meningococcal vaccine GSK134612 (Nimenrix)Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. |
Who may qualify
- Ages
- 4 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
- For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
- Written informed consent obtained from the subject/ 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 (19 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine.
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- For the MPS Group, vaccination against meningococcal disease after completion of study 102394
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 |
|---|---|---|
| Meningococcal vaccine GSK134612 (Nimenrix)one dose, as intramuscular injection | Biological | Mencevax Naive Group, Mencevax Primed Group |
Primary outcome
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
Time frame: One month post-vaccination (Month 1)
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
9 secondary outcomes
Meningococcal rSBA Titers
Time frame: Prior to vaccination (Day 0)
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Time frame: Prior to (Day 0) and one month post-vaccination (Month 1)
Anti-tetanus Toxoid Antibody Concentrations
Time frame: Prior to (Day 0) and one month post-vaccination (Month 1)
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
Time frame: One month post-vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Day 0 to Day 3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Day 0 to Day 3) period after vaccination
Number of Subjects With Unsolicited Symptoms
Time frame: Up to one month post-vaccination (Month 1)
Number of Subjects Reporting Any Serious Adverse Events
Time frame: Day 0 to study month 6
Number of Subjects With Any Specific Adverse Events
Time frame: Day 0 to study month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22704725Dbaibo G, Van der Wielen M, Reda M, Medlej F, Tabet C, Boutriau D, Sumbul A, Anis S, Miller JM. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine. Int J Infect Dis. 2012 Aug;16(8):e608-15. doi: 10.1016/j.ijid.2012.04.006. Epub 2012 Jun 14.
- BackgroundDbaibo G et al. One dose of the meningococcal tetravalent tetanus toxoid conjugated vaccine (MenACWY-TT) is immunogenic with an acceptable safety profile in unvaccinated subjects and those previously vaccinated with a MenACWY polysaccharide vaccine. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.
- 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 2 study testing Meningococcal vaccine GSK134612 (Nimenrix) in people with Infections, Meningococcal, run by GlaxoSmithKline at 1 site in Lebanon.
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 19 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 28 Dec 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 Lebanon. 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 28 Dec 2018). 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?
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers (time frame: One month post-vaccination (Month 1)). 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 NCT00661557, 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 28 Dec 2018.