Infections, MeningococcalPhase 3NCT00508261

Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

A Phase 3 study testing Meningococcal vaccine GSK134612, Infanrix™ hexa and Meningitec™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 89 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™. Read more about this study

Who is it for?: Ages 12 to 23 monthsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: Meningococcal vaccine GSK134612, Infanrix™ hexa and Meningitec™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 793 participants
Where: 89 sitesin 3 countries
Study dates: 1 Aug 2007to 27 Oct 2008
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 12 to 23 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, 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 first vaccine dose.
Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.
Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.

Show all 15Show fewer

History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
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 study period.
Additional criteria for subjects receiving Infanrix hexa™
Hypersensitivity reaction due to previous vaccination with Infanrix hexa™.
Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.

Trial locations and contacts

89 sites in 3 countries.

Country

City, postcode or hospital

89 sites in 3 countries

Germany77 sites

GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Balve, North Rhine-Westphalia, 58802
GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 10627
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 12679
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 13355
GSK Investigational Site
Berlin, 13507
GSK Investigational Site
Berlin, 14197
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357
GSK Investigational Site
Braunatal, Hesse, 34225
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015
GSK Investigational Site
Datteln, North Rhine-Westphalia, 45711
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44329
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44379
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Eschwege, Hesse, 37269
GSK Investigational Site
Espelkamp, North Rhine-Westphalia, 32339
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Gau-Odernheim, Rhineland-Palatinate, 55239
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332
GSK Investigational Site
Hamburg, 22089
GSK Investigational Site
Hamburg, 22307
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955
GSK Investigational Site
Heilbronn, Baden-Wurttemberg, 74072
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76189
GSK Investigational Site
Kaufbeuren, Bavaria, 87600
GSK Investigational Site
Kaufering, Bavaria, 86916
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Kronach, Bavaria, 96317
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Oppenheim, Rhineland-Palatinate, 55276
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, 75172
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457
GSK Investigational Site
Rodgau, Hesse, 63110
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059
GSK Investigational Site
Salzgitter, Lower Saxony, 38226
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42719
GSK Investigational Site
Speyer, Rhineland-Palatinate, 67346
GSK Investigational Site
Stollberg, Saxony, 09366
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tettnang, Baden-Wurttemberg, 88069
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Velbert, North Rhine-Westphalia, 42551
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41749
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Wiesbaden, Hesse, 65205
GSK Investigational Site
Wildeshausen, Lower Saxony, 27793
GSK Investigational Site
Wurzen, Saxony, 04808

Other trials in Germany

Greece7 sites

GSK Investigational Site
Athens, 115 27
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Didimoteicho, 68300
GSK Investigational Site
Karditsa, 43100
GSK Investigational Site
Komotini, 69 100
GSK Investigational Site
Thessaloniki, 54636
GSK Investigational Site
Véria, 591 00

Other trials in Greece

Austria5 sites

GSK Investigational Site
Eferding, A-4070
GSK Investigational Site
Neufeld/Leitha, A 2491
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Villach, A-9500
GSK Investigational Site
Wels, A-4600

Other trials in Austria

About this study

Official title: Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Read the detailed description

Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™.

For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.

For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

Conditions: Infections, Meningococcal
Being tested: Meningococcal vaccine GSK134612, Infanrix™ hexa, Meningitec™
Keywords: Meningococcal vaccine, Immunogenicity, Routine infancy vaccination, Safety
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 GSK134612Biological
Single dose intramuscular injection
Infanrix™ hexaBiological
Single dose intramuscular injection
Meningitec™Biological
Single dose intramuscular injection

Study groups in NCT00508261
Study group	Role	What they receive
Group A	Experimental	Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™ Receives: Biological: Meningococcal vaccine GSK134612; Biological: Infanrix™ hexa
Group B	Experimental	Meningococcal vaccine GSK134612 followed one month later by Infanrix hexa™ Receives: Biological: Meningococcal vaccine GSK134612; Biological: Infanrix™ hexa
Group C	Active comparator	Infanrix hexa™ followed one month later by Meningococcal vaccine GSK134612 Receives: Biological: Meningococcal vaccine GSK134612; Biological: Infanrix™ hexa
Group D	Active comparator	Meningitec™ vaccination Receives: Biological: Meningitec™

What is being measured

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

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.
The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.
Measured: 1 month after vaccination with Nimenrix vaccine (Month 1)
Anti-PT, Anti-FHA and Anti-PRN Concentrations
The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: 1 month after the first vaccination (Month 1)
Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off
The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).
Measured: 1 month after vaccination with Nimenrix vaccine (Month 1)
Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off
The cut-off for the assay was ≥ 1μg/mL.
Measured: 1 month after vaccination with Nimenrix vaccine (Month 1)

Secondary outcomes (25)

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
The cut-off values for the assay were ≥ 1:8 and ≥ 1:128
Measured: At month 0, month 1 and month 2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
The results were tabulated as geometric mean expressed in titers.
Measured: At month 0, month 1 and month 2
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off
The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.
Measured: At month 0, month 1 and month 2
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).
Measured: At month 0, month 1 and month 2
Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)
The cut-off for the assay was ≥ 0.1
Measured: At month 0, month 1 and month 2
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).
Measured: At month 0, month 1 and month 2
Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off
The cut-off for the assay was ≥ 0.1
Measured: At month 0, month 1 and month 2
Anti-diphtheria (Anti-D) Antibody Concentrations
The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).
Measured: At month 0, month 1 and month 2
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off
The cut-off for the assay was ≥ 1:8.
Measured: At month 0, month 1 and month 2
Anti-polio Type 1, 2 & 3 Titers
The results for the assay were tabulated as geometric mean expressed in titers.
Measured: At month 0, 1 and 2
Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off
The cut-off for the assay was ≥ 1.0
Measured: At month 0, month 1 and month 2
Anti-PRP Antibody Concentrations
The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).
Measured: At month 0, month 1 and month 2
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs
The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .
Measured: At month 0, month 1 and month 2
Anti-HBs Antibody Concentrations
The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).
Measured: At month 0, month 1 and month 2
Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens
Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration < 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination.
The analysis was based only on subjects receiving experimental vaccination.
Measured: 1 month after vaccination (Month 1)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At month 0, month 1 and month 2
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.
Measured: During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination
The analysis was based only on subjects receiving combined-diphtheria vaccination.
Measured: During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose
Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship.
Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)
Number of Subjects Reporting Any Rash
Any was defined as occurrence of at least one symptom experienced.
Measured: Day 0 - Month 7
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)
Any was defined as occurrence of at least one symptom experienced.
Measured: Day 0 - Month 7
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)
Any was defined as occurrence of at least one symptom experienced.
Measured: Day 0 - Month 7
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose
An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: Occurring within Day 0-30 following vaccination
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose
An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
The analysis was based only on subjects receiving a second dose of vaccination.
Measured: Occurring within Day 0-30 following vaccination
Number of Subjects Reporting Any 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: From dose 1 (Month 0) up to study end (Month 7)

Timeline

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

1 Aug 200727 Oct 2008

First posted27 Jul 2007 (estimated)
Study start1 Aug 2007
Primary completion26 May 2008
Study completion27 Oct 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 793 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00508261
Sponsor's protocol ID: 109835
Status last verified: May 2017
First submitted: 26 Jul 2007
Last updated: 24 Jan 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.

Publications

Knuf M, Pantazi-Chatzikonstantinou A, Pfletschinger U, Tichmann-Schumann I, Maurer H, Maurer L, Fischbach T, Zinke H, Pankow-Culot H, Papaevangelou V, Bianco V, Van der Wielen M, Miller JM. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. Vaccine. 2011 Jun 6;29(25):4264-73. doi: 10.1016/j.vaccine.2011.03.009. Epub 2011 Mar 21.
PubMed 21420417
Maurer H et al. Co-administration of MENACWY-TT conjugate vaccine with DTPA-HBV-IPV/HIB vaccine does not impair immune response to DTPA-HBV-IPV/HIB, and has an acceptable safety profile. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

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

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Infections, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children
ClinicalTrials.gov ID: NCT00508261
Acronym / sponsor ID: 109835
Conditions: Infections, Meningococcal
Keywords: Meningococcal vaccine, Immunogenicity, Routine infancy vaccination, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 793 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Aug 2007
Primary completion: 26 May 2008 (actual)
Study completion: 27 Oct 2008 (actual)
First posted: 27 Jul 2007 (estimated)
Results: Posted 24 Jan 2019

Clinical summary

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

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.

For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Biological: Meningococcal vaccine GSK134612, Biological: Infanrix™ hexaMeningococcal vaccine GSK134612 co-administered with Infanrix hexa™
Group B	Experimental	Biological: Meningococcal vaccine GSK134612, Biological: Infanrix™ hexaMeningococcal vaccine GSK134612 followed one month later by Infanrix hexa™
Group C	Active comparator	Biological: Meningococcal vaccine GSK134612, Biological: Infanrix™ hexaInfanrix hexa™ followed one month later by Meningococcal vaccine GSK134612
Group D	Active comparator	Biological: Meningitec™Meningitec™ vaccination

Who may qualify

Ages: 12 to 23 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.

Key exclusion criteria (15 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, 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 first vaccine dose.
Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.

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 GSK134612Single dose intramuscular injection	Biological	Group A, Group B, Group C
Infanrix™ hexaSingle dose intramuscular injection	Biological	Group A, Group B, Group C
Meningitec™Single dose intramuscular injection	Biological	Group D

Primary outcome

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.
Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)
The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.
Anti-PT, Anti-FHA and Anti-PRN Concentrations
Time frame: 1 month after the first vaccination (Month 1)
The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off
Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)
The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).
Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off
Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)
The cut-off for the assay was ≥ 1μg/mL.

25 secondary outcomes

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
Time frame: At month 0, month 1 and month 2
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Time frame: At month 0, month 1 and month 2
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off
Time frame: At month 0, month 1 and month 2
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
Time frame: At month 0, month 1 and month 2
Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)
Time frame: At month 0, month 1 and month 2
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Time frame: At month 0, month 1 and month 2
Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off
Time frame: At month 0, month 1 and month 2
Anti-diphtheria (Anti-D) Antibody Concentrations
Time frame: At month 0, month 1 and month 2
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off
Time frame: At month 0, month 1 and month 2
Anti-polio Type 1, 2 & 3 Titers
Time frame: At month 0, 1 and 2
Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off
Time frame: At month 0, month 1 and month 2
Anti-PRP Antibody Concentrations
Time frame: At month 0, month 1 and month 2
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs
Time frame: At month 0, month 1 and month 2
Anti-HBs Antibody Concentrations
Time frame: At month 0, month 1 and month 2
Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens
Time frame: 1 month after vaccination (Month 1)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: At month 0, month 1 and month 2
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Time frame: During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination
Time frame: During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose
Time frame: During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)
Number of Subjects Reporting Any Rash
Time frame: Day 0 - Month 7
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)
Time frame: Day 0 - Month 7
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)
Time frame: Day 0 - Month 7
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose
Time frame: Occurring within Day 0-30 following vaccination
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose
Time frame: Occurring within Day 0-30 following vaccination
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: From dose 1 (Month 0) up to study end (Month 7)

Results and safety

Results posted to the registry on 24 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 + Infanrix-hexa Group	222	219
Nimenrix Group	220	212
Infanrix-Hexa Group	224	218
Meningitec Group	127	126

Primary outcome: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1). Count of participants. Unit: Participants

Measure	Nimenrix + Infanrix-hexa Group n = 193	Nimenrix Group n = 186
rSBA-MenA, M1	193	180
rSBA-MenC, M1	191	178
rSBA-MenW-135, M1	193	183
rSBA-MenY, M1	192	180

Nimenrix + Infanrix-hexa Group vs Nimenrix Group: Difference in percentages: 1.64 (95% CI -0.33 to 4.71)
Nimenrix + Infanrix-hexa Group vs Nimenrix Group: Difference in percentages: 2.73 (95% CI 0.73 to 6.24)
Nimenrix + Infanrix-hexa Group vs Nimenrix Group: Difference in percentages: 1.61 (95% CI -0.36 to 4.64)

Population analysed: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Anti-PT, Anti-FHA and Anti-PRN Concentrations

Time frame: 1 month after the first vaccination (Month 1). Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Nimenrix + Infanrix-hexa Group n = 191	Infanrix-Hexa Group n = 179
Anti-PT, M1	86 (77 to 95)	85 (75 to 96)
Anti-FHA, M1	542 (492 to 597)	544 (485 to 611)
Anti-PRN, M1	470 (411 to 537)	450 (387 to 522)

Nimenrix + Infanrix-hexa Group vs Infanrix-Hexa Group: Adjusted GMC ratios: 0.97 (95% CI 0.83 to 1.12)
Nimenrix + Infanrix-hexa Group vs Infanrix-Hexa Group: Adjusted GMC ratios: 0.98 (95% CI 0.85 to 1.13)
Nimenrix + Infanrix-hexa Group vs Infanrix-Hexa Group: Adjusted GMC ratios: 0.92 (95% CI 0.78 to 1.1)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at month 1.

Primary outcome: Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1). Count of participants. Unit: Participants

Measure	Nimenrix + Infanrix-hexa Group n = 181	Infanrix-Hexa Group n = 169
Value	180	166

Nimenrix + Infanrix-hexa Group vs Infanrix-Hexa Group: Difference in percentages: 1.22 (95% CI -1.47 to 4.6)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. The analysis for the primary outcome measure was based only on subjects receiving Infanrix-hexa vaccination at Month 1.

Primary outcome: Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1). Count of participants. Unit: Participants

Measure	Nimenrix + Infanrix-hexa Group n = 184	Infanrix-Hexa Group n = 173
Value	183	170

Nimenrix + Infanrix-hexa Group vs Infanrix-Hexa Group: Difference in percentages: 1.19 (95% CI -1.45 to 4.5)

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix + Infanrix-hexa Group	10 of 222 (4.5%)	166 of 222 (74.8%)	0 of 222
Nimenrix Group	8 of 220 (3.6%)	183 of 220 (83.2%)	0 of 220
Infanrix-Hexa Group	11 of 224 (4.9%)	185 of 224 (82.6%)	1 of 224
Meningitec Group	6 of 127 (4.7%)	75 of 127 (59.1%)	0 of 127

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21420417Knuf M, Pantazi-Chatzikonstantinou A, Pfletschinger U, Tichmann-Schumann I, Maurer H, Maurer L, Fischbach T, Zinke H, Pankow-Culot H, Papaevangelou V, Bianco V, Van der Wielen M, Miller JM. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. Vaccine. 2011 Jun 6;29(25):4264-73. doi: 10.1016/j.vaccine.2011.03.009. Epub 2011 Mar 21.
BackgroundMaurer H et al. Co-administration of MENACWY-TT conjugate vaccine with DTPA-HBV-IPV/HIB vaccine does not impair immune response to DTPA-HBV-IPV/HIB, and has an acceptable safety profile. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 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.

Related trials for Infections, Meningococcal

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

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

89 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal vaccine GSK134612, Infanrix™ hexa and Meningitec™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 89 sites in 3 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 5 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: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in Germany, Greece, Austria. 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 24 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 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. (time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)). 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 NCT00508261, 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 24 Jan 2019.