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

NCT00474266 | Completed Phase 3 Results

• 2 other identifiers: 1096702006-006580-23
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Infections, Meningococcal

Keywords

MMRV vaccine; co-administration; immunogenicity; meningococcal vaccine; conjugate vaccine

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (22)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values

  Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

  Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

• Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values

  Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

• Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values

  Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

• 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

  Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

Study Arms (4)

Nimenrix + Priorix-Tetra Group

EXPERIMENTAL

Subjects received 1 dose of Nimenrix vaccine and 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.

Biological: Meningococcal vaccine GSK134612 (Nimenrix); Biological: Priorix-Tetra

Nimenrix Group

EXPERIMENTAL

Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

Biological: Meningococcal vaccine GSK134612 (Nimenrix); Biological: Priorix-Tetra

Priorix-Tetra Group

ACTIVE COMPARATOR

Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.

Biological: Priorix-Tetra; Biological: Meningitec

Meningitec Group

ACTIVE COMPARATOR

Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

Biological: Priorix-Tetra; Biological: Meningitec

Interventions

Meningococcal vaccine GSK134612 (Nimenrix) BIOLOGICAL

Single dose intramuscular injection

Nimenrix + Priorix-Tetra Group; Nimenrix Group

Priorix-Tetra BIOLOGICAL

2-dose subcutaneous injection

Meningitec Group; Nimenrix + Priorix-Tetra Group; Nimenrix Group; Priorix-Tetra Group

Meningitec BIOLOGICAL

Single dose intramuscular injection

Meningitec Group; Priorix-Tetra Group

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Espoo, 02100, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kotka, 48600, Finland

Location

GSK Investigational Site

Kuopio, 70100, Finland

Location

GSK Investigational Site

Lahti, 15140, Finland

Location

GSK Investigational Site

Oulu, 90100, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vantaa, 01300, Finland

Location

GSK Investigational Site

Vantaa, 01600, Finland

Location

Related Publications (2)

• 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.

  PMID: 21443965 BACKGROUND

• 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.

  PMID: 26780033 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Priorix-Tetra vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 16, 2007
• Study Start: June 5, 2007
• Primary Completion: February 26, 2008
• Study Completion: March 26, 2008
• Last Updated: November 18, 2019
• Results First Posted: December 15, 2017

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

FI (14)