Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Toddlers

Original Study ID : V59P21

Secondary ID : BB-IND 11278

NCT ID : NCT00626327

Brief Title : Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Toddlers

Official Title : A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers

Brief Summary : Safety immune response of Novartis MenACWY conjugate vaccine when given to healthy toddlers

Source : Novartis

Overall Status : Active, not recruiting

Start Date : March 2008

End Date : June 2010

Completion Date : June 2010

Official Title : Phase 3

Phase : Interventional

Study Design : Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Enrollment : 1830

Verification Date : April 2008

First Received Date : February 20, 2008

Trial Eligibility

Criteria :
Inclusion Criteria:

- who are healthy 7 to 9 months olds and 12 month olds (inclusive) and for whom, after
the nature of the study has been explained, the parent or legal guardian has provided
written informed consent;

- who have received complete primary vaccination with recommended licensed vaccines;

- who are available for all visits and telephone calls scheduled for the study;

Exclusion Criteria:

- whose parent or legal guardian is unwilling or unable to give written informed
consent

- who had a previous or suspected disease caused by N. meningitidis;

- who had previous or suspected infection with measles, mumps, rubella, varicella,
and/or herpes zoster;

- who had household contact with and/or intimate exposure to an individual with
culture-proven N. meningitidis infection within 60 days prior to enrollment;

- who had household contact with and/or intimate exposure to an individual with measles,
mumps, rubella and/or varicella infection within 60 days prior to enrollment;

- who have previously been immunized with a meningococcal vaccine or vaccine containing
meningococcal antigen(s)

- who have previously received any measles, mumps, rubella or varicella vaccine either
alone or in any combination;

- who have received any investigational agents or vaccines within 90 days prior to
enrollment or who expect to receive an investigational agent or vaccine prior to the
completion of the study;

- who have any serious acute, chronic or progressive disease such as, cancer, diabetes,
heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome

- who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of
the vaccine,

- who have a known or suspected impairment/alteration of immune function, either
congenital or acquired

- who have Down's syndrome or other known cytogenic disorders;

Gender : Both

Minimum Age : 7 Months

Maximum Age : 1 Year

Healthy Volunteers : Accepts He

Facilities

Facility Name : Drug Research and Analysis Corporation

City : Montgomery

State : Alabama

Zip Code : 36106

Country : United States

Facility Name : Birmingham Pediatric Associates

City : Birmingham

State : Alabama

Zip Code : 35205

Country : United States

Facility Name : Southeastern Pediatrics Associate, PA

City : Dothan

State : Alabama

Zip Code : 36305

Country : United States

Facility Name : Arkansas Pediatric Clinical Research

City : Little Rock

State : Arkansas

Zip Code : 72205

Country : United States

Facility Name : Children's Investigational Research Program, LLC

City : Bentonville

State : Arkansas

Zip Code : 72712

Country : United States

Facility Name : The Children's Clinic of Jonesboro

City : Jonesboro

State : Arkansas

Zip Code : 72401

Country : United States