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Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Toddlers
This study is ongoing, but not recruiting participants.
First Received: February 20, 2008   Last Updated: December 22, 2009   History of Changes
Sponsor: Novartis
Collaborator: Novartis Vaccines
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00626327
  Purpose

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


Condition Intervention Phase
Meningococcal Infections
Biological: MenACWY and MMRV
Biological: MMRV
Phase III

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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate safety and immune response across groups at pre-defined time points [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To further evaluate safety and immunogencity across groups at pre-defined time points [ Time Frame: 13.5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1830
Study Start Date: March 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: MenACWY and MMRV
V1: MenACWY, V3: MenACWY plus MMRV vaccine at 9 and 12 months of age.
2: Experimental Biological: MenACWY and MMRV
V1: MenACWY, V3: MenACWY and V4: MMRV vaccine at 9, 12 and 13.5 months of age
3: Active Comparator Biological: MMRV
V3: MMRV at 12 months of age

  Eligibility

Ages Eligible for Study:   7 Months to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626327

  Show 89 Study Locations
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis Vaccines ( Novartis )
Study ID Numbers: V59P21, BB-IND 11278
Study First Received: February 20, 2008
Last Updated: December 22, 2009
ClinicalTrials.gov Identifier: NCT00626327     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
vaccine
toddlers
healthy
meningitis
meningococcal
measles
mumps
rubella
varicella
Prevention of Meningococcal disease types ACWY

Additional relevant MeSH terms:
Bacterial Infections
Meningococcal Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on February 08, 2010