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Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine (ETH-TVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994695
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 16, 2009
World Health Organization
Addis Ababa University
Information provided by:
Armauer Hansen Research Institute, Ethiopia

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.


  • 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.


  • 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

Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Biological: Mencevax ACW Vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians
Study Start Date : November 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Intervention Details:
  • Biological: Mencevax ACW Vaccine
    Mencevax ACW polysaccharide vaccine subcutaneously in the left arm at 50 μg in 0.5ml(reconstituted).
    Other Name: Mencevax ACW polysaccharide vaccine

Primary Outcome Measures :
  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) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination. [ Time Frame: 28days ]
  2. To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination. [ Time Frame: 23 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age between 2-29 years, both sexes, living in the selected villages of Butajira area
  2. 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.
  3. Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment

Exclusion Criteria:

  1. Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
  2. 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.
  3. Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
  4. Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since 1999.
  5. Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
  6. A family history of congenital or hereditary immunodeficiency.
  7. History of allergic reaction to any component of the vaccine
  8. 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.
  9. Pregnancy.
  10. lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994695

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Butajira Hospital
Butajira, Southern Nationality, Ethiopia
Sponsors and Collaborators
Armauer Hansen Research Institute, Ethiopia
World Health Organization
Addis Ababa University
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Principal Investigator: Abraham Aseffa Aseffa, M.D, PhD Senior Sientist,Deputy Director, AHRI
Principal Investigator: Ahmed Bedru Omer, M.D,Pediatrician Clinical Trial coordinator,AHRI

Publications of Results:
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Responsible Party: Dr.Ahmed Bedru Omer, One of the Principal Investigators., Armauer Hansen Research Institute Identifier: NCT00994695     History of Changes
Other Study ID Numbers: AHRI/WHO/IVB-1
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009
Keywords provided by Armauer Hansen Research Institute, Ethiopia:
Trivalent meningococcal polysaccharide vaccine
To assess Safety of trivalent meningococcal polysaccharide vaccine in children
To assess the immunogenicity of the trivalent polysaccharide vaccine in children
Additional relevant MeSH terms:
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Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs