Clinical trial NCT00474266: Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children
Official title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: MMRV vaccine
co-administration
immunogenicity
meningococcal vaccine
conjugate vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 1000
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 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra.

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

Detailed description: Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days.

Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days.

For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.

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 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 parents' or legal guardians' knowledge.

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 vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s).
* Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
* History of meningococcal disease.
* Previous vaccination against measles, mumps, rubella, and/or varicella.
* History of measles, mumps, rubella and/or varicella.
* Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
* 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin.
* 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.

Primary outcomes:
measure: Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values
timeFrame: 42 days after the first vaccine dose (Day 42)
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
timeFrame: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
timeFrame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
measure: Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
timeFrame: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
measure: Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values
timeFrame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
measure: Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
timeFrame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
measure: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
timeFrame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
measure: Anti-measles Antibody Concentrations
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Anti-measles Antibody Concentrations
timeFrame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
measure: Anti-mumps Antibody Concentrations
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Anti-mumps Antibody Concentrations
timeFrame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
measure: Anti-rubella Antibody Concentrations
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Anti-rubella Antibody Concentrations
timeFrame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
measure: Anti-varicella Antibody Titers
timeFrame: 42 days after the first vaccine dose (Day 42)
measure: Anti-varicella Antibody Titers
timeFrame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)
measure: Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination
timeFrame: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
measure: Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0
timeFrame: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
measure: Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms
timeFrame: During the 43-day (Days 0-42) after first vaccination dose
measure: Number of Subjects Reporting Specific Adverse Events (AEs)
timeFrame: From Day 0 up to Month 6 after first vaccine dose
measure: Number of Subjects Reporting Unsolicited Symptoms
timeFrame: During the 43-day (Days 0-42) post Dose 1 vaccination period
measure: Number of Subjects Reporting Unsolicited Symptoms
timeFrame: During the 43-day (Days 0-42) follow-up period after each vaccination
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to Month 6 after vaccination
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kotka
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Lahti
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Karvonen A, Bianco V, Van der Wielen M, Miller J. Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial. Vaccine. 2011 Jun 6;29(25):4274-84. doi: 10.1016/j.vaccine.2011.03.043. Epub 2011 Apr 6.
citation: Vesikari T, Forsten A, Bianco V, Van der Wielen M, Miller JM. Immunogenicity, Safety and Antibody Persistence of a Booster Dose of Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine Compared with Monovalent Meningococcal Serogroup C Vaccine Administered Four Years After Primary Vaccination Using the Same Vaccines. Pediatr Infect Dis J. 2015 Dec;34(12):e298-307. doi: 10.1097/INF.0000000000000897.