Clinical trial NCT00508261: Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Meningococcal vaccine
Immunogenicity
Routine infancy vaccination
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-27
Enrollment: 793
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.
timeFrame: 1 month after vaccination with Nimenrix vaccine (Month 1)
measure: Anti-PT, Anti-FHA and Anti-PRN Concentrations
timeFrame: 1 month after the first vaccination (Month 1)
measure: Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off
timeFrame: 1 month after vaccination with Nimenrix vaccine (Month 1)
measure: Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off
timeFrame: 1 month after vaccination with Nimenrix vaccine (Month 1)
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
timeFrame: At month 0, month 1 and month 2
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
timeFrame: At month 0, month 1 and month 2
measure: Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off
timeFrame: At month 0, month 1 and month 2
measure: Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations
timeFrame: At month 0, month 1 and month 2
measure: Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)
timeFrame: At month 0, month 1 and month 2
measure: Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
timeFrame: At month 0, month 1 and month 2
measure: Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off
timeFrame: At month 0, month 1 and month 2
measure: Anti-diphtheria (Anti-D) Antibody Concentrations
timeFrame: At month 0, month 1 and month 2
measure: Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off
timeFrame: At month 0, month 1 and month 2
measure: Anti-polio Type 1, 2 & 3 Titers
timeFrame: At month 0, 1 and 2
measure: Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off
timeFrame: At month 0, month 1 and month 2
measure: Anti-PRP Antibody Concentrations
timeFrame: At month 0, month 1 and month 2
measure: Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs
timeFrame: At month 0, month 1 and month 2
measure: Anti-HBs Antibody Concentrations
timeFrame: At month 0, month 1 and month 2
measure: Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens
timeFrame: 1 month after vaccination (Month 1)
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: At month 0, month 1 and month 2
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
timeFrame: During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination
timeFrame: During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination
measure: Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose
timeFrame: During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)
measure: Number of Subjects Reporting Any Rash
timeFrame: Day 0 - Month 7
measure: Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)
timeFrame: Day 0 - Month 7
measure: Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)
timeFrame: Day 0 - Month 7
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose
timeFrame: Occurring within Day 0-30 following vaccination
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose
timeFrame: Occurring within Day 0-30 following vaccination
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
timeFrame: From dose 1 (Month 0) up to study end (Month 7)
Other outcomes:
Locations:
city: Eferding
country: Austria
facility: GSK Investigational Site
city: Neufeld/Leitha
country: Austria
facility: GSK Investigational Site
city: Salzburg
country: Austria
facility: GSK Investigational Site
city: Villach
country: Austria
facility: GSK Investigational Site
city: Wels
country: Austria
facility: GSK Investigational Site
city: Boennigheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bretten
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heilbronn
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Karlsruhe
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Marbach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberstenfeld
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Pforzheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tettnang
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kaufbeuren
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kaufering
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kronach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Braunatal
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rodgau
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Salzgitter
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wildeshausen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Oeynhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Balve
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Datteln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Erkrath
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Espelkamp
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hille
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Moenchengladbach
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Viersen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Gau-Odernheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Oppenheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Speyer
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Stollberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Wurzen
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Harrislee
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neumuenster
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Niebuell
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Lobenstein
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Neuhaus am Rennweg
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Didimoteicho
country: Greece
facility: GSK Investigational Site
city: Karditsa
country: Greece
facility: GSK Investigational Site
city: Komotini
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Veria
country: Greece
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.