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

NCT ID: NCT00474266

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-05
• Study Completion Date: 2008-03-26

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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nimenrix + Priorix-Tetra Group

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.

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612 (Nimenrix)

Intervention Type: BIOLOGICAL

Single dose intramuscular injection

Priorix-Tetra

Intervention Type: BIOLOGICAL

2-dose subcutaneous injection

Nimenrix Group

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

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612 (Nimenrix)

Intervention Type: BIOLOGICAL

Single dose intramuscular injection

Priorix-Tetra

Intervention Type: BIOLOGICAL

2-dose subcutaneous injection

Priorix-Tetra Group

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.

Group Type: ACTIVE_COMPARATOR

Priorix-Tetra

Intervention Type: BIOLOGICAL

2-dose subcutaneous injection

Meningitec

Intervention Type: BIOLOGICAL

Single dose intramuscular injection

Meningitec Group

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

Group Type: ACTIVE_COMPARATOR

Priorix-Tetra

Intervention Type: BIOLOGICAL

2-dose subcutaneous injection

Meningitec

Intervention Type: BIOLOGICAL

Single dose intramuscular injection

Interventions

Meningococcal vaccine GSK134612 (Nimenrix)

Single dose intramuscular injection

Intervention Type: BIOLOGICAL

Priorix-Tetra

2-dose subcutaneous injection

Intervention Type: BIOLOGICAL

Meningitec

Single dose intramuscular injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , 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

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Vantaa, , Finland

GSK Investigational Site

Vantaa, , Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 21443965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26780033 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

2006-006580-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109670

Identifier Type: -

Identifier Source: org_study_id