Clinical Trials Logo

Clinical Trial Summary

This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age.

Primary Objective:

To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.

Secondary Objectives:

Immunogenicity

- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.

- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine.

Safety

- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00384397
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date September 2006
Completion date February 2009

See also
  Status Clinical Trial Phase
Completed NCT04183114 - Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study) Phase 2/Phase 3
Completed NCT00092430 - Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016) Phase 3
Completed NCT02196285 - Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella Phase 1
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00402831 - ProQuad® Intramuscular vs Subcutaneous Phase 3
Completed NCT00560755 - Safety Study of ProQuad® rHA in Infants (V221-037) Phase 3
Completed NCT01878435 - Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya N/A
Completed NCT01777529 - Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations Phase 4
Terminated NCT00258726 - Immune Responses to Two Dose Varivax +/- MMR-II Phase 1/Phase 2
Completed NCT00109278 - A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED) Phase 2
Not yet recruiting NCT05771779 - Co-administration Study of OCV, TCV and MR Phase 3
Completed NCT02880865 - Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine Phase 4
Completed NCT01681992 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life Phase 3
Completed NCT00751348 - Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 Phase 3
Completed NCT01702428 - Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age Phase 3
Completed NCT00969436 - Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM Phase 3
Completed NCT00566527 - Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038) Phase 3
Completed NCT00127010 - Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases Phase 3
Completed NCT00388440 - Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore. Phase 4
Completed NCT03148990 - Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella Phase 2/Phase 3