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Infections, MeningococcalPhase 2NCT00126984

Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

A Phase 2 study testing Conjugated meningococcal ACWY-TT (vaccine), DTPa/Hib containing vaccine and Meningitec in people with Infections, Meningococcal, run by GlaxoSmithKline at 42 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

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. Read more about this study

Who is it for?
Ages 12 to 14 monthsHealthy volunteers can take part
Conditions the study is for
Infections, Meningococcal
What is being tested?
Conjugated meningococcal ACWY-TT (vaccine), DTPa/Hib containing vaccine and Meningitec
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
42 sitesin 2 countries
Study dates
Jul 2005to Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

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 14 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 14 months or 3 and 5 years 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
  • Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (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 a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine.
  • Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
  • Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
  • For subjects aged 12-14 months at enrolment, a DTPa/Hib containing booster vaccination, in the second year of life: these booster vaccines will be given at Visit 2.
Show all 15Show fewer
  • History of meningococcal serogroup A, C, W-135 or Y disease.
  • Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • 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.

Trial locations and contacts

42 sites in 2 countries.

42 sites in 2 countries

Germany37 sites

  • GSK Investigational Site

    Bad Lobenstein, Thuringia, 07356

  • GSK Investigational Site

    Berlin, State of Berlin, 10315

  • GSK Investigational Site

    Berlin, State of Berlin, 10967

  • GSK Investigational Site

    Berlin, State of Berlin, 10999

  • GSK Investigational Site

    Berlin, State of Berlin, 12627

  • GSK Investigational Site

    Berlin, State of Berlin, 12679

  • GSK Investigational Site

    Berlin, State of Berlin, 13055

  • GSK Investigational Site

    Berlin, State of Berlin, 13355

  • GSK Investigational Site

    Berlin, State of Berlin, 14197

  • GSK Investigational Site

    Bietigheim-Bissingen, Baden-Wurttemberg, 74321

  • GSK Investigational Site

    Bindlach, Bavaria, 95463

  • GSK Investigational Site

    Bobingen, Bavaria, 86399

  • GSK Investigational Site

    Bodenheim, Rhineland-Palatinate, 55294

  • GSK Investigational Site

    Bretten, Baden-Wurttemberg, 75015

  • GSK Investigational Site

    Döbeln, Saxony, 04720

  • GSK Investigational Site

    Dresden, Saxony, 01169

  • GSK Investigational Site

    Eppelheim, Baden-Wurttemberg, 69214

  • GSK Investigational Site

    Gerolstein, Rhineland-Palatinate, 54568

  • GSK Investigational Site

    Leipzig, Saxony, 04178

  • GSK Investigational Site

    Ludwigsburg, Baden-Wurttemberg, 71634

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68309

  • GSK Investigational Site

    Munich, Bavaria, 80939

  • GSK Investigational Site

    Munich, Bavaria, 81675

  • GSK Investigational Site

    Munich, Bavaria, 81735

  • GSK Investigational Site

    Nördlingen, Bavaria, 86720

  • GSK Investigational Site

    Nuremberg, Bavaria, 90473

  • GSK Investigational Site

    Oberstenfeld, Baden-Wurttemberg, 71720

  • GSK Investigational Site

    Olching, Bavaria, 82140

  • GSK Investigational Site

    Stollberg, Saxony, 09366

  • GSK Investigational Site

    Tegernsee, Bavaria, 83684

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54294

  • GSK Investigational Site

    Tutzing, Bavaria, 82327

  • GSK Investigational Site

    Weilheim, Bavaria, 82362

  • GSK Investigational Site

    Weimar, Thuringia, 99425

  • GSK Investigational Site

    Worms, Rhineland-Palatinate, 67547

Other trials in Germany

Austria5 sites

  • GSK Investigational Site

    Guessing, A-7540

  • 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: A Phase II, Open (Partially Double-blind), Randomized, Controlled Dose-range Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Investigational Vaccination Regimens Versus MENINGITEC™ or MENCEVAX™ ACWY When Given as One Dose to Children Aged 12 to 14 Months and 3 to 5 Years Old

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Read the detailed description

The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.

Being tested
Conjugated meningococcal ACWY-TT (vaccine), DTPa/Hib containing vaccine, Meningitec, Mencevax ACWY
Keywords
Safety, Reactogenicity, Immunogenicity, Meningococcal vaccine, Dose selection, Conjugate 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.

  • Conjugated meningococcal ACWY-TT (vaccine)Biological

    One intramuscular dose during the primary vaccination

  • DTPa/Hib containing vaccineBiological

    One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

  • MeningitecBiological

    One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age

  • Mencevax ACWYBiological

    One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Study groups in NCT00126984
Study groupRoleWhat they receive
Group AExperimentalSubjects of 12-14 months of age or 3-5 years of age who will receive formulation A
Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa/Hib containing vaccine
Group BExperimentalSubjects of 12-14 months of age or 3-5 years of age who will receive formulation B
Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa/Hib containing vaccine
Group CExperimentalSubjects of 12-14 months of age or 3-5 years of age who will receive formulation C
Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa/Hib containing vaccine; Biological: Mencevax ACWY
Group DExperimentalSubjects of 12-14 months of age or 3-5 years of age who will receive formulation D
Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa/Hib containing vaccine
Group EActive comparatorSubjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY.
Receives: Biological: DTPa/Hib containing vaccine; Biological: Meningitec; Biological: Mencevax ACWY

What is being measured

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

  1. Percentage of meningococcal rSBA responders, in all subjects

    Measured: One month after the first vaccine dose

Secondary outcomes (7)

  1. Meningococcal rSBA titres

    Measured: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose

  2. Anti-meningococcal polysaccharide concentrations

    Measured: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose

  3. Anti-tetanus toxoid seropositivity and antibody concentrations

    Measured: Prior to and one month after administration of the first vaccine dose, in all subjects

  4. Meningococcal hSBA titers

    Measured: Prior to & 1 month after the 1st dose and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose

  5. Occurrence of local and general solicited adverse events

    Measured: During the 8-day follow-up period following the administration of each vaccine dose.

  6. Occurrence of unsolicited adverse events

    Measured: During the 31-day follow-up period following the administration of each vaccine dose.

  7. Occurrence of any serious adverse events

    Measured: Throughout the study

Timeline

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

  1. First posted5 Aug 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00126984
Sponsor's protocol ID
104703 (Primary study)
Other IDs
104704
Status last verified
Oct 2016
First submitted
4 Aug 2005
Last updated
7 Oct 2016
Results posted
No
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, Kieninger-Baum D, Habermehl P, Muttonen P, Maurer H, Vink P, Poolman J, Boutriau D. A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children. Vaccine. 2010 Jan 8;28(3):744-53. doi: 10.1016/j.vaccine.2009.10.064. Epub 2009 Nov 1.

    PubMed 19887137

  • Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother. 2012 Jul;8(7):866-72. doi: 10.4161/hv.20229. Epub 2012 Apr 9.

    PubMed 22485049

  • Knuf M et al. Antibody persistence and immune memory 15 months after meningococcal tetravalent tetanus toxoid conjugate (ACWY-TT) vaccine in toddlers and 3-5 year-olds. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

  • Prieler et al. Immunogenicity of 1 dose of a candidate meningococcal tetravalent tetanus toxoid conjugate (MenACWY-TT) vaccine in 12-14 month and 3-5 year olds. Abstract presented at the 47th Annual Meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, IL, 17-20 September 2007.

  • Prieler et al. Immunogenicity of 1-dose of a new meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine in children 12-14 months and 3-5 years old. Abstract presented at the 9th Meeting of The European Monitoring Group on Meningococci (EMGM). Rome, Italy, 30 May-1 June 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Conjugated meningococcal ACWY-TT (vaccine), DTPa/Hib containing vaccine and Meningitec in people with Infections, Meningococcal, run by GlaxoSmithKline at 42 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 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Germany, 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of meningococcal rSBA responders, in all subjects (time frame: One month after the first vaccine dose). 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 NCT00126984, which also lists 5 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 7 Oct 2016.

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