NCT00994695

Brief Summary

Primary objective: To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups. Secondary Objectives:

  • To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination
  • To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups Study site:Two rural communities (Kebele) in Butajira district, Ethiopia. Methods:
  • Phase II, open and parallel safety and immunogenicity trial.
  • 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting.
  • Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously.
  • Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination.
  • Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, \& 28.
  • Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination.
  • Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23. Results:
  • No significant difference in the incidence of general or local AEFI was observed between the age groups
  • The statistical analysis for the Immunogenicity data is in progress

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

October 13, 2009

Last Update Submit

October 15, 2009

Conditions

Meningococcal Meningitis

Keywords

Trivalent meningococcal polysaccharide vaccineChildrenSafetyImmunogenicityTo assess Safety of trivalent meningococcal polysaccharide vaccine in childrenTo assess the immunogenicity of the trivalent polysaccharide vaccine in children

Outcome Measures

Primary Outcomes (1)

  • To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive)

    28 days

Secondary Outcomes (2)

  • To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination.

    28days

  • To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination.

    23 month

Interventions

Mencevax ACW VaccineBIOLOGICAL

Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).

Also known as: Mencevax ACW polysaccharide vaccine

Eligibility Criteria

Age2 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 2-29 years, both sexes, living in the selected villages of Butajira area
  • A written informed consent signed by the individual (\>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
  • Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment

You may not qualify if:

  • Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
  • Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
  • Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic reaction to any component of the vaccine
  • Presence of any fever (defined as axillary temperature of 37.5 degree centigrade or more) and/or severe illness on the day of enrolment/ vaccination.
  • Pregnancy.
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butajira Hospital

Butajīra, Southern Nationality, Ethiopia

Location

Related Publications (1)

  • Aseffa A, Bedru A, Yamuah L, Arga D, Worku A, Chandramohan D, Nelson CB, Engers HD. Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia. Vaccine. 2007 Sep 3;25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4.

    PMID: 17548138RESULT

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Abraham Aseffa Aseffa, M.D, PhD

    Senior Sientist,Deputy Director, AHRI

    PRINCIPAL INVESTIGATOR

  • Ahmed Bedru Omer, M.D,Pediatrician

    Clinical Trial coordinator,AHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

November 1, 2005

Primary Completion

January 1, 2006

Study Completion

November 1, 2007

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

ET(1)