Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474266
• Other study ID #: 109670
• Secondary ID: 2006-006580-23
• Status: Completed
• Phase: Phase 3
• Start date: June 5, 2007
• Est. completion date: March 26, 2008

Study information

• Verified date: November 2019
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 26, 2008
• Est. primary completion date: February 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 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.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal vaccine GSK134612 (Nimenrix)
Single dose intramuscular injection
• Priorix-Tetra
2-dose subcutaneous injection
• Meningitec
Single dose intramuscular injection

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Kotka
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Vantaa
Finland	GSK Investigational Site	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (=) the Cut-off Values	The cut-off values for the rSBA titers were = 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.	42 days after the first vaccine dose (Day 42)
Primary	Number of Subjects With Anti-measles Antibody Concentrations = the Cut-off Values	The cut-off values for anti-measles antibody concentrations were = 150 milli-international units per milliliter (mIU/mL).	42 days after the first vaccine dose (Day 42)
Primary	Number of Subjects With Anti-mumps Antibody Concentrations = the Cut-off Values	The cut-off values for anti-mumps antibody concentrations were = 231 units per milliliter (U/mL).	42 days after the first vaccine dose (Day 42)
Primary	Number of Subjects With Anti-rubella Antibody Concentrations = the Cut-off Values.	The cut-off values for anti-rubella antibody concentrations were = 4 international units per milliliter (IU/mL).	42 days after the first vaccine dose (Day 42)
Primary	Number of Subjects With Anti-varicella Antibody Concentrations = the Cut-off Values	The cut-off values for anti-varicella antibody concentrations were = 1:4.	42 days after the first vaccine dose (Day 42)
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 rSBA titers were = 1:8 and = 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.	Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)
Secondary	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Secondary	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations = the Cut-off Values	Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (µg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.	Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Secondary	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations = the Cut-off Values	The cut-off values for anti-PS antibody concentrations were = 0.3 µg/mL and = 2.0 µg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Secondary	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	The cut-off values for hSBA antibody titers were = 1:4 and = 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Secondary	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)
Secondary	Anti-measles Antibody Concentrations	Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.	42 days after the first vaccine dose (Day 42)
Secondary	Anti-measles Antibody Concentrations	Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.	42 days after the second Priorix-Tetra vaccine dose (Day 126)
Secondary	Anti-mumps Antibody Concentrations	Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.	42 days after the first vaccine dose (Day 42)
Secondary	Anti-mumps Antibody Concentrations	Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.	42 days after the second Priorix-Tetra vaccine dose (Day 126)
Secondary	Anti-rubella Antibody Concentrations	Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.	42 days after the first vaccine dose (Day 42)
Secondary	Anti-rubella Antibody Concentrations	Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.	42 days after the second Priorix-Tetra vaccine dose (Day 126)
Secondary	Anti-varicella Antibody Titers	Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.	42 days after the first vaccine dose (Day 42)
Secondary	Anti-varicella Antibody Titers	Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.	42 days after the second Priorix-Tetra vaccine dose (Day 126)
Secondary	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.	During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
Secondary	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.	During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
Secondary	Number of Subjects Reporting Solicited General Symptoms	Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature = 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.	During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups
Secondary	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Solicited general symptoms assessed were fever (measured rectally and temperature = 38.0°C ), Meningismus, Parotiditis and Rash.	During the 43-day (Days 0-42) after first vaccination dose
Secondary	Number of Subjects Reporting Specific Adverse Events (AEs)	Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.	From Day 0 up to Month 6 after first vaccine dose
Secondary	Number of Subjects Reporting Unsolicited Symptoms	Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.	During the 43-day (Days 0-42) post Dose 1 vaccination period
Secondary	Number of Subjects Reporting Unsolicited Symptoms	Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.	During the 43-day (Days 0-42) follow-up period after each vaccination
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.	From Day 0 up to Month 6 after vaccination

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