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

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508261
• Other study ID #: 109835
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2007
• Est. completion date: October 27, 2008

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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™.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: October 27, 2008
• Est. primary completion date: May 26, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal vaccine GSK134612
Single dose intramuscular injection
• Infanrix™ hexa
Single dose intramuscular injection
• Meningitec™
Single dose intramuscular injection

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Eferding
Austria	GSK Investigational Site	Neufeld/Leitha
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Villach
Austria	GSK Investigational Site	Wels
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Balve	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Boennigheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Braunatal	Hessen
Germany	GSK Investigational Site	Bretten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Datteln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Erkrath	Nordrhein-Westfalen
Germany	GSK Investigational Site	Eschwege	Hessen
Germany	GSK Investigational Site	Espelkamp	Nordrhein-Westfalen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Gau-Odernheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Guetersloh	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Harrislee	Schleswig-Holstein
Germany	GSK Investigational Site	Heilbronn	Baden-Wuerttemberg
Germany	GSK Investigational Site	Heiligenhaus	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hille	Nordrhein-Westfalen
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kaufbeuren	Bayern
Germany	GSK Investigational Site	Kaufering	Bayern
Germany	GSK Investigational Site	Kleve-Materborn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kronach	Bayern
Germany	GSK Investigational Site	Lobenstein	Thueringen
Germany	GSK Investigational Site	Loehne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marbach	Baden-Wuerttemberg
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neuhaus am Rennweg	Thueringen
Germany	GSK Investigational Site	Neumuenster	Schleswig-Holstein
Germany	GSK Investigational Site	Niebuell	Schleswig-Holstein
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Oberkirch	Baden-Wuerttemberg
Germany	GSK Investigational Site	Oberstenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Oppenheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Pforzheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Porta Westfalica	Nordrhein-Westfalen
Germany	GSK Investigational Site	Rodgau	Hessen
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Salzgitter	Niedersachsen
Germany	GSK Investigational Site	Schwaebisch-Hall	Baden-Wuerttemberg
Germany	GSK Investigational Site	Solingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Speyer	Rheinland-Pfalz
Germany	GSK Investigational Site	Stollberg	Sachsen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tettnang	Baden-Wuerttemberg
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Velbert	Nordrhein-Westfalen
Germany	GSK Investigational Site	Viersen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Wildeshausen	Niedersachsen
Germany	GSK Investigational Site	Wurzen	Sachsen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Didimoteicho
Greece	GSK Investigational Site	Karditsa
Greece	GSK Investigational Site	Komotini
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Veria

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Germany,  Greece, 

References & 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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	At month 0, month 1 and month 2
Secondary	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	The results were tabulated as geometric mean expressed in titers.	At month 0, month 1 and month 2
Secondary	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.	At month 0, month 1 and month 2
Secondary	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).	At month 0, month 1 and month 2
Secondary	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	The cut-off for the assay was = 0.1	At month 0, month 1 and month 2
Secondary	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).	At month 0, month 1 and month 2
Secondary	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) = the Cut-off	The cut-off for the assay was = 0.1	At month 0, month 1 and month 2
Secondary	Anti-diphtheria (Anti-D) Antibody Concentrations	The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).	At month 0, month 1 and month 2
Secondary	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 = the Cut-off	The cut-off for the assay was = 1:8.	At month 0, month 1 and month 2
Secondary	Anti-polio Type 1, 2 & 3 Titers	The results for the assay were tabulated as geometric mean expressed in titers.	At month 0, 1 and 2
Secondary	Numbers of Seroprotected Subjects for Anti-PRP = the Cut-off	The cut-off for the assay was = 1.0	At month 0, month 1 and month 2
Secondary	Anti-PRP Antibody Concentrations	The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (µg/mL).	At month 0, month 1 and month 2
Secondary	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 .	At month 0, month 1 and month 2
Secondary	Anti-HBs Antibody Concentrations	The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).	At month 0, month 1 and month 2
Secondary	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.	1 month after vaccination (Month 1)
Secondary	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).	At month 0, month 1 and month 2
Secondary	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.	During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination
Secondary	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.	During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination
Secondary	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.	During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)
Secondary	Number of Subjects Reporting Any Rash	Any was defined as occurrence of at least one symptom experienced.	Day 0 - Month 7
Secondary	Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	Any was defined as occurrence of at least one symptom experienced.	Day 0 - Month 7
Secondary	Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	Any was defined as occurrence of at least one symptom experienced.	Day 0 - Month 7
Secondary	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.	Occurring within Day 0-30 following vaccination
Secondary	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.	Occurring within Day 0-30 following vaccination
Secondary	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.	From dose 1 (Month 0) up to study end (Month 7)

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