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

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126984
• Other study ID #: 104703 (Primary study)
• Secondary ID: 104704
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2005
• Last updated: October 6, 2016
• Start date: July 2005
• Est. completion date: February 2008

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 14 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 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.

Exclusion Criteria:

• 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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
• DTPa/Hib containing vaccine
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
• Meningitec
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
• Mencevax ACWY
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)

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Guessing
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	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	Bietigheim/Bissingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bindlach	Bayern
Germany	GSK Investigational Site	Bobingen	Bayern
Germany	GSK Investigational Site	Bodenheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Bretten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Eppelheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Gerolstein	Rheinland-Pfalz
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Lobenstein	Thueringen
Germany	GSK Investigational Site	Ludwigsburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oberstenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Stollberg	Sachsen
Germany	GSK Investigational Site	Tegernsee	Bayern
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Tutzing	Bayern
Germany	GSK Investigational Site	Weilheim	Bayern
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Worms	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (5)

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.

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of meningococcal rSBA responders, in all subjects		One month after the first vaccine dose	No
Secondary	Meningococcal rSBA titres		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	No
Secondary	Anti-meningococcal polysaccharide concentrations		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	No
Secondary	Anti-tetanus toxoid seropositivity and antibody concentrations		Prior to and one month after administration of the first vaccine dose, in all subjects	No
Secondary	Meningococcal hSBA titers		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	No
Secondary	Occurrence of local and general solicited adverse events		During the 8-day follow-up period following the administration of each vaccine dose.	No
Secondary	Occurrence of unsolicited adverse events		During the 31-day follow-up period following the administration of each vaccine dose.	No
Secondary	Occurrence of any serious adverse events		Throughout the study	No

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