Infections, MeningococcalPhase 3NCT01266993

Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children

A Phase 3 study testing Nimenrix (GSK134612 vaccine) and Menjugate in people with Infections, Meningococcal and Meningococcal Vaccines, run by GlaxoSmithKline at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal, Meningococcal Vaccines
What is being tested?: Nimenrix (GSK134612 vaccine) and Menjugate
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 271 participants
Where: 24 sitesin 2 countries
Study dates: 3 Jan 2011to 17 May 2014
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 4 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study (NCT number = NCT00674583).
Written informed consent obtained from the parent(s)/Legally Acceptable Representatives(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
Healthy subjects as established by medical history and clinical examination before entering into the study.
All subjects must meet the additional following criteria prior to receiving the booster vaccination:
Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study.

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Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

Child in care.
Use of any investigational or non-registered product within 30 days preceding the first persistence blood sample or planned use within 30 days preceding a blood sample during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed).
Concurrently participating in another clinical study or planned participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product within 30 days of a blood sample.
History of meningococcal disease.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).

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Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
Serious chronic illness.
Administration of immunoglobulins and/or blood products within the 3 months preceding the subject's first visit.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.
Exclusion criteria for booster vaccination to be checked at Visit 4 (Month 68)
Child in care.
Use of any investigational or non-registered product within 30 days preceding the booster vaccination or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed).
Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the study period.
Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, (from the time of the booster until the end of the study) in which the subject has been or will be exposed to an investigational or a non-investigational product.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Hypersensitivity to latex.
Planned administration/ administration of a vaccine not foreseen by the study protocol within the last 30 days of the dose of vaccine(s) with the exception of a licensed inactivated influenza vaccine.
Previous vaccination with tetanus toxoids within the last 30 days.
A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Serious chronic illness.
History of any neurological disorders or seizures (although subjects with a prior history of a single episode of benign febrile seizures may be allowed to participate in the study).
Acute disease and/or fever at the time of vaccination.
History of chronic alcohol consumption and/or drug abuse.
History of hypotonic-hyporesponsive episodes (HHEs) following vaccination.
Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.
Pregnant or lactating female.
Female of child-bearing potential planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

Germany16 sites

GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 10627
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 14197
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42719
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

France8 sites

GSK Investigational Site
Draguignan, 83300
GSK Investigational Site
Le Havre, 76600
GSK Investigational Site
Lingolsheim, 67380
GSK Investigational Site
Miribel, 01700
GSK Investigational Site
Nice, 06300
GSK Investigational Site
Paris, 75015
GSK Investigational Site
Saint-Laurent-du-Var, 06700
GSK Investigational Site
Tours, 37000

Other trials in France

About this study

Official title: Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination

The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®.

This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)

Read the detailed description

Subjects were previously vaccinated at 2 to 10 years of age with GSK134612 or with Menjugate®. The persistence phase starts 32 months after the primary vaccination and blood samples will be taken at 32, 44, 56 and 68 months after primary vaccination. All subjects will receive a booster dose of GSK134612 at 68 months after primary vaccination and a blood sample will be taken 1 month after administration of the booster dose.

Conditions: Infections, Meningococcal, Meningococcal Vaccines
Being tested: Nimenrix (GSK134612 vaccine), Menjugate
Keywords: Immunogenicity, Persistence, Safety, Conjugate vaccine, Meningococcal vaccine
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nimenrix (GSK134612 vaccine)Biological
Intramuscular, 1 dose
MenjugateBiological
Intramuscular, 1 dose

Study groups in NCT01266993
Study group	Role	What they receive
Nimenrix Group	Experimental	Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Nimenrix (GSK134612 vaccine)
Menjugate Group	Experimental	Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Menjugate vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Menjugate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 32, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 44, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 56, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 68, post-primary vaccination

Secondary outcomes (28)

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 32, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 44, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 56, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 68, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 32, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 44, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 56, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 68, post-primary vaccination
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 32, post-primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 44, post-primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 56, post-primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed in all subjects, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 68, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 32, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 44, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Measured: At Month 56, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 68, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8.
The pre-defined cut-off values of the assay for the rSBA titers were greater than or equal to (≥) 1:128 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 69, one month post-booster vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 69, one month post-booster vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 69, one month post-booster vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Measured: At Month 69, one month post-booster vaccination
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers <1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥1:8).
Measured: At Month 69, one month post-booster vaccination
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY was defined as hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titers <1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titers ≥1:4).
Measured: At Month 69, one month post-booster vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 50 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.
Measured: During the 4-day (Days 0-3) period following the booster vaccination
Number of Subjects With Any, Grade 3 and Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = Fatigue that prevented normal activity. Grade 3 Gastrointestinal symptoms = Gastrointestinal symptoms that prevented normal everyday activities. Grade 3 Headache = Headache that prevented normal acitivity. Grade 3 Fever = Rectal temperature higher than (>) 39.5°C.
Measured: During the 4-day (Days 0-3) period following the booster vaccination
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: During the 31-day (Days 0-30) period following the booster vaccination
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 31-day (Days 0-30) period following the booster vaccination
Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies.
Measured: During the 31-day (Days 0-30) period following the booster vaccination
Number of Subjects With 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.
Measured: Up to Month 32, 44, 56 and 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 201117 May 2014

First posted24 Dec 2010 (estimated)
Study start3 Jan 2011
Primary completion31 Mar 2014
Study completion17 May 2014

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 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01266993
Sponsor's protocol ID: 113977
Other IDs: 2010-018730-51
Status last verified: Nov 2020
First submitted: 16 Dec 2010
Last updated: 23 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
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Meningococcal Disease
RecruitingPhase 3
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Epidemic Meningitis, Meningococcal Vaccines

All Infections, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination
ClinicalTrials.gov ID: NCT01266993
Acronym / sponsor ID: 113977
Conditions: Infections, Meningococcal, Meningococcal Vaccines
Keywords: Immunogenicity, Persistence, Safety, Conjugate vaccine, Meningococcal vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 271 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Jan 2011 (actual)
Primary completion: 31 Mar 2014 (actual)
Study completion: 17 May 2014 (actual)
First posted: 24 Dec 2010 (estimated)
Results: Posted 31 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nimenrix Group	Experimental	Biological: Nimenrix (GSK134612 vaccine)Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Menjugate Group	Experimental	Biological: MenjugateHealthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Menjugate vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.

Who may qualify

Ages: 4 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (11 listed)

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study (NCT number = NCT00674583).
Written informed consent obtained from the parent(s)/Legally Acceptable Representatives(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
Healthy subjects as established by medical history and clinical examination before entering into the study.
All subjects must meet the additional following criteria prior to receiving the booster vaccination:

Key exclusion criteria (36 listed)

Child in care.
Use of any investigational or non-registered product within 30 days preceding the first persistence blood sample or planned use within 30 days preceding a blood sample during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed).
Concurrently participating in another clinical study or planned participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product within 30 days of a blood sample.
History of meningococcal disease.

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
Nimenrix (GSK134612 vaccine)Intramuscular, 1 dose	Biological	Nimenrix Group
MenjugateIntramuscular, 1 dose	Biological	Menjugate Group

Primary outcome

Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32.
Time frame: At Month 32, post-primary vaccination
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44.
Time frame: At Month 44, post-primary vaccination
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56.
Time frame: At Month 56, post-primary vaccination
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68.
Time frame: At Month 68, post-primary vaccination
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

28 secondary outcomes

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32.
Time frame: At Month 32, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44.
Time frame: At Month 44, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56.
Time frame: At Month 56, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68.
Time frame: At Month 68, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32.
Time frame: At Month 32, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44.
Time frame: At Month 44, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56.
Time frame: At Month 56, post-primary vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68.
Time frame: At Month 68, post-primary vaccination
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32.
Time frame: At Month 32, post-primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44.
Time frame: At Month 44, post-primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56.
Time frame: At Month 56, post-primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68.
Time frame: At Month 68, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32.
Time frame: At Month 32, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44.
Time frame: At Month 44, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56.
Time frame: At Month 56, post-primary vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68.
Time frame: At Month 68, post-primary vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8.
Time frame: At Month 69, one month post-booster vaccination
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Time frame: At Month 69, one month post-booster vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8.
Time frame: At Month 69, one month post-booster vaccination
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY
Time frame: At Month 69, one month post-booster vaccination
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Time frame: At Month 69, one month post-booster vaccination
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Time frame: At Month 69, one month post-booster vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) period following the booster vaccination
Number of Subjects With Any, Grade 3 and Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) period following the booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) period following the booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the 31-day (Days 0-30) period following the booster vaccination
Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs)
Time frame: During the 31-day (Days 0-30) period following the booster vaccination
Number of Subjects With Serious Adverse Events SAEs
Time frame: Up to Month 32, 44, 56 and 68

Results and safety

Results posted to the registry on 31 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nimenrix Group	199	199
Menjugate Group	72	72

Primary outcome: Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32.

Time frame: At Month 32, post-primary vaccination. Count of participants. Unit: Participants

Measure	Nimenrix Group n = 193	Menjugate Group n = 69
rSBA-MenA	167	15
rSBA-MenC	124	53
rSBA-MenW-135	149	5
rSBA-MenY	157	10

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.

Primary outcome: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44.

Time frame: At Month 44, post-primary vaccination. Count of participants. Unit: Participants

Measure	Nimenrix Group n = 189	Menjugate Group n = 66
rSBA-MenA	162	17
rSBA-MenC	70	30
rSBA-MenW-135	129	7
rSBA-MenY	118	4

Population analysed: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.

Primary outcome: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56.

Time frame: At Month 56, post-primary vaccination. Count of participants. Unit: Participants

Measure	Nimenrix Group n = 186	Menjugate Group n = 65
rSBA-MenA	161	19
rSBA-MenC	110	42
rSBA-MenW-135	145	17
rSBA-MenY	149	14

Population analysed: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.

Primary outcome: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68.

Time frame: At Month 68, post-primary vaccination. Count of participants. Unit: Participants

Measure	Nimenrix Group n = 178	Menjugate Group n = 61
rSBA-MenA	154	18
rSBA-MenC	71	38
rSBA-MenW-135	94	9
rSBA-MenY	127	8

Population analysed: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (Month 32 up to Month 69).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix Group	0 of 179 (0%)	130 of 179 (72.6%)	0 of 179
Menjugate Group	0 of 62 (0%)	48 of 62 (77.4%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nimenrix (GSK134612 vaccine) and Menjugate in people with Infections, Meningococcal and Meningococcal Vaccines, run by GlaxoSmithKline at 24 sites in 2 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 11 inclusion and 36 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, France. 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 31 Jan 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 Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. (time frame: At Month 32, post-primary vaccination). The study lists 4 primary outcomes in all. 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 NCT01266993.

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 23 Nov 2020.