Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994695
Other study ID # AHRI/WHO/IVB-1
Secondary ID
Status Completed
Phase Phase 2
First received October 13, 2009
Last updated October 15, 2009
Start date November 2005
Est. completion date November 2007

Study information

Verified date October 2009
Source Armauer Hansen Research Institute, Ethiopia
Contact n/a
Is FDA regulated No
Health authority Switzerland:WHO-ERCEthiopia:Ethiopian national Ethical review CommitteeEthiopia: Ministry of HealthEthiopia: Drug Administration and regulatory Authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 412
Est. completion date November 2007
Est. primary completion date January 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 29 Years
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Ethiopia Butajira Hospital Butajira Southern Nationality

Sponsors (4)

Lead Sponsor Collaborator
Armauer Hansen Research Institute, Ethiopia Addis Ababa University, LSHTM,UK, World Health Organization

Country where clinical trial is conducted

Ethiopia, 

References & 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. Epub 2007 May 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination. 28days Yes
Secondary To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination. 23 month No
See also
  Status Clinical Trial Phase
Completed NCT01434680 - Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers Phase 2
Completed NCT01424644 - A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents Phase 4
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT01214837 - Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life Phase 3
Completed NCT00874549 - Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years Phase 1/Phase 2
Completed NCT00355121 - Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® Phase 2
Completed NCT02591290 - Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects Phase 4
Completed NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 Phase 3
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT01482052 - Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis Phase 1
Completed NCT01239043 - Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination Phase 2
Completed NCT01732627 - Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older Phase 2
Completed NCT01478347 - A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults Phase 3
Completed NCT00483574 - Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers Phase 3
Completed NCT00474487 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults Phase 3
Completed NCT03205358 - Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 2
Not yet recruiting NCT06226714 - A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds Phase 3
Completed NCT00667602 - Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers Phase 3
Completed NCT00450437 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults Phase 3