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

Novartis

Status and phase

Completed

Phase 3

Conditions

Meningococcal Infections

Treatments

Biological: MMRV

Biological: MenACWY-CRM + MMRV

Biological: MenACWY-CRM

Study type

Interventional

Funder types

Industry

Identifiers

BB-IND 11278

V59P21

Details and patient eligibility

About

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers

Enrollment

1,630 patients

Sex

All

Ages

7 months to 1 year old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) 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 assent 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; bleeding diathesis