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

PHASE3CompletedINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

April 30, 2012

Study Completion Date

May 31, 2012

Conditions
Meningococcal DiseaseMeningococcal Meningitis
Interventions
BIOLOGICAL

MenACWY-CRM

This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

BIOLOGICAL

MenACWY-CRM

This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.

BIOLOGICAL

Routine Vaccines

Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Trial Locations (40)

66604

Cotton ONeil Clinical Research, Topeka

66614

Cotton ONeil Clinical Research, Topeka

99202

Rockwood Clinic P S, Spokane

99218

Rockwood Clinic P S, Spokane

Unknown

Birmingham

Fayetteville

Jonesboro

Little Rock

Fountain Valley

Huntington Beach

Madera

Nampa

Bardstown

Bluegrass Clinical Research (Bardstown Road), Louisville

Bluegrass Clinical Research (Brownsboro Park Blvd), Louisville

Springfield

Haughton

Shreveport

Niles

Lincoln

Children's Physicians Dundee, Omaha

Creighton Univ, Omaha

Binghamton

Johnson City

Syracuse

Dayton

Huber Heights

Kettering

Tulsa

Kingsport

Lebanon

San Antonio

Tomball

Layton

Salt Lake City

St. George

Richmond

Greater Sudbury

Toronto

Pierrefonds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

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 | Biotech Hunter | Biotech Hunter