At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States
In Brief
A Phase 3 clinical trial evaluating MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, and 7 other interventions for Healthy Volunteers (Meningococcal Infection). Completed, enrolled 2,627 participants across 70 sites in 2 countries.
Detailed Summary
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
Study Details
Timeline
Interventions
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
MMR vaccine at 12 months of age, Subcutaneous
Varicella vaccine at 12 months of age
Hepatitis A vaccine at 15 to 18 months of age