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

NCT00508261 | Completed Phase 3 Results

• 1 other identifier: 109835
• Study Type: interventional
• Target: 793
• Locations: 3 countries
• Sites: 89

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

Conditions

Infections, Meningococcal

Keywords

Meningococcal vaccine; Immunogenicity; Routine infancy vaccination; Safety

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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).

  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.

  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

  At month 0, month 1 and month 2

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers

  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

  At month 0, month 1 and month 2

• Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations

  At month 0, month 1 and month 2

• Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)

  At month 0, month 1 and month 2

Study Arms (4)

Group A

EXPERIMENTAL

Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™

Biological: Meningococcal vaccine GSK134612; Biological: Infanrix™ hexa

Group B

EXPERIMENTAL

Meningococcal vaccine GSK134612 followed one month later by Infanrix hexa™

Biological: Meningococcal vaccine GSK134612; Biological: Infanrix™ hexa

Group C

ACTIVE COMPARATOR

Infanrix hexa™ followed one month later by Meningococcal vaccine GSK134612

Biological: Meningococcal vaccine GSK134612; Biological: Infanrix™ hexa

Group D

ACTIVE COMPARATOR

Meningitec™ vaccination

Biological: Meningitec™

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

Single dose intramuscular injection

Group A; Group B; Group C

Infanrix™ hexa BIOLOGICAL

Single dose intramuscular injection

Group A; Group B; Group C

Meningitec™ BIOLOGICAL

Single dose intramuscular injection

Group D

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (89)

GSK Investigational Site

Eferding, A-4070, Austria

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GSK Investigational Site

Neufeld/Leitha, A 2491, Austria

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GSK Investigational Site

Salzburg, A-5020, Austria

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GSK Investigational Site

Villach, A-9500, Austria

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GSK Investigational Site

Wels, A-4600, Austria

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GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, 74357, Germany

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GSK Investigational Site

Bretten, Baden-Wurttemberg, 75015, Germany

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GSK Investigational Site

Heilbronn, Baden-Wurttemberg, 74072, Germany

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GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, 76189, Germany

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

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GSK Investigational Site

Marbach, Baden-Wurttemberg, 71672, Germany

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GSK Investigational Site

Oberkirch, Baden-Wurttemberg, 77704, Germany

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GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, 71720, Germany

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GSK Investigational Site

Pforzheim, Baden-Wurttemberg, 75172, Germany

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GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

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GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

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GSK Investigational Site

Tettnang, Baden-Wurttemberg, 88069, Germany

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GSK Investigational Site

Aschaffenburg, Bavaria, 63739, Germany

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GSK Investigational Site

Kaufbeuren, Bavaria, 87600, Germany

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GSK Investigational Site

Kaufering, Bavaria, 86916, Germany

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GSK Investigational Site

Kronach, Bavaria, 96317, Germany

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GSK Investigational Site

Munich, Bavaria, 81241, Germany

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GSK Investigational Site

Munich, Bavaria, 81675, Germany

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GSK Investigational Site

Munich, Bavaria, 81735, Germany

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GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

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GSK Investigational Site

Olching, Bavaria, 82140, Germany

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Braunatal, Hesse, 34225, Germany

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Eschwege, Hesse, 37269, Germany

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Rodgau, Hesse, 63110, Germany

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Wiesbaden, Hesse, 65205, Germany

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Salzgitter, Lower Saxony, 38226, Germany

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Wildeshausen, Lower Saxony, 27793, Germany

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GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18059, Germany

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GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, 32549, Germany

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GSK Investigational Site

Balve, North Rhine-Westphalia, 58802, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

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Datteln, North Rhine-Westphalia, 45711, Germany

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GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

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Dortmund, North Rhine-Westphalia, 44329, Germany

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GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44379, Germany

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GSK Investigational Site

Erkrath, North Rhine-Westphalia, 40699, Germany

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GSK Investigational Site

Espelkamp, North Rhine-Westphalia, 32339, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

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GSK Investigational Site

Gütersloh, North Rhine-Westphalia, 33332, Germany

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GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

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GSK Investigational Site

Hille, North Rhine-Westphalia, 32479, Germany

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GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

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Krefeld, North Rhine-Westphalia, 47798, Germany

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Löhne, North Rhine-Westphalia, 32584, Germany

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Minden, North Rhine-Westphalia, 32427, Germany

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Mönchengladbach, North Rhine-Westphalia, 41061, Germany

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GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, 32457, Germany

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GSK Investigational Site

Solingen, North Rhine-Westphalia, 42719, Germany

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GSK Investigational Site

Velbert, North Rhine-Westphalia, 42551, Germany

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GSK Investigational Site

Viersen, North Rhine-Westphalia, 41749, Germany

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GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

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Gau-Odernheim, Rhineland-Palatinate, 55239, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Oppenheim, Rhineland-Palatinate, 55276, Germany

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Speyer, Rhineland-Palatinate, 67346, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

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GSK Investigational Site

Stollberg, Saxony, 09366, Germany

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GSK Investigational Site

Wurzen, Saxony, 04808, Germany

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GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

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GSK Investigational Site

Flensburg, Schleswig-Holstein, 24944, Germany

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GSK Investigational Site

Harrislee, Schleswig-Holstein, 24955, Germany

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GSK Investigational Site

Husum, Schleswig-Holstein, 25813, Germany

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GSK Investigational Site

Neumünster, Schleswig-Holstein, 24534, Germany

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GSK Investigational Site

Niebüll, Schleswig-Holstein, 25899, Germany

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GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

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GSK Investigational Site

Neuhaus am Rennweg, Thuringia, 98724, Germany

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GSK Investigational Site

Weimar, Thuringia, 99425, Germany

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GSK Investigational Site

Berlin, 10315, Germany

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GSK Investigational Site

Berlin, 10627, Germany

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GSK Investigational Site

Berlin, 12627, Germany

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GSK Investigational Site

Berlin, 12679, Germany

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GSK Investigational Site

Berlin, 13055, Germany

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GSK Investigational Site

Berlin, 13355, Germany

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GSK Investigational Site

Berlin, 13507, Germany

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GSK Investigational Site

Berlin, 14197, Germany

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GSK Investigational Site

Hamburg, 22089, Germany

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GSK Investigational Site

Hamburg, 22307, Germany

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GSK Investigational Site

Athens, 115 27, Greece

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GSK Investigational Site

Athens, 11527, Greece

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GSK Investigational Site

Didimoteicho, 68300, Greece

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GSK Investigational Site

Karditsa, 43100, Greece

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GSK Investigational Site

Komotini, 69 100, Greece

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GSK Investigational Site

Thessaloniki, 54636, Greece

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GSK Investigational Site

Véria, 591 00, Greece

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Related Publications (2)

• 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.

  PMID: 21420417 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: August 1, 2007
• Primary Completion: May 26, 2008
• Study Completion: October 27, 2008
• Last Updated: January 24, 2019
• Results First Posted: January 24, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (77); GR (7); AU (5)