B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00488683
First received: June 19, 2007
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age


Condition Intervention Phase
Meningococcal Disease
Biological: MenACWY-CRM
Biological: DTaP-Hib_IPV
Biological: PCV
Biological: MMR
Biological: Hib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells predicts the specific serum bactericidal activity using human complement of (respectively) serogroup A, C, W-135 and Y at 12 months of age
  • The safety and tolerability of Novartis MenACWY vaccine concomitantly with a combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine and a heptavalent PCV.

Secondary Outcome Measures:
  • Whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells predicts the concentration of (respectively) serogroup A, C, W-135 and Y specific IgG and memory B-cells at 12 months of age
  • Whether the frequency of meningococcal serogroup A,C,W-135 and Y specific memory B Cells predicts serogroup A,C,W-135 and Y specific memory B-cells and IgG concentrations and hSBA titers 1 month after a booster of MenACWY administered at 12 months of age
  • Whether the frequency of meningococcal serogroup A,C,W-135,Y specific B Cells predicts the rise from prebooster levels in serogroup A,C,W-135,Y specific IgG and B-cell conc. and hSBA titers 1 month after a booster of MenACWY admin. at 12 months of age
  • Whether the frequency of meningococcal serogroup A,C,W135,Y specific B Cells predicts the conc. of serogroup A,C,W135,Y specific plasma cells and B-cells and specific IgG and hSBA titers in the week after a booster of MenACWY admin. at 12months of age
  • Whether the frequency of CRM197 specific memory B Cells predicts the concentration of CRM197 specific IgG and memory B Cells at 12 months of age and one month following a booster dose of MenACWY administered at 12 months of age

Enrollment: 216
Study Start Date: May 2007
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-DTaP/DTaP-Hib-IPV/PCV/MMR
MenACWY-CRM vaccine together with a course of DTaP-Hib-IPV, and a course of PCV. MMR and a booster dose of Hib were also offered at varying schedules.
Biological: MenACWY-CRM
IM injections of MenACWY conjugate vaccine supplied as an extemporaneous mixing were offered at 2, 4, and 12-month course.
Biological: DTaP-Hib_IPV
IM injection of 3 doses of DTaP-Hib-IPV supplied in prefilled vial were offered at 2, 3, and 4-month course.
Other Name: combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine; Pediacel
Biological: PCV
IM injection of 3 doses of PCV supplied in pre-filled syringe containing a single dose were offered at 2, 4, and 12 or 13-month course.
Other Name: Heptavalent Streptoccus pneumonia; Prevenar
Biological: MMR
IM injection of 1 dose of MMR obtained by extemporaneous mixing was offered at 13 months.
Other Name: measles, mumps, and rubella vaccine
Biological: Hib
IM injection of 1 dose of Hib, supplied in pre-filled syringe was offered at 13 months.
Other Name: Vaxem Hib
Experimental: MenACWY-DTaP/DTaP-Hib-IPV/PCV/MMR (II)
MenACWY-CRM together with a course of DTaP-Hib-IPV, and a course of PCV. MMR and a booster dose of Hib were also offered at varying schedules.
Biological: MenACWY-CRM
IM injections of MenACWY conjugate vaccine supplied as an extemporaneous mixing were offered at 2, 4, and 12-month course.
Biological: DTaP-Hib_IPV
IM injection of 3 doses of DTaP-Hib-IPV supplied in prefilled vial were offered at 2, 3, and 4-month course.
Other Name: combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine; Pediacel
Biological: PCV
IM injection of 3 doses of PCV supplied in pre-filled syringe containing a single dose were offered at 2, 4, and 12 or 13-month course.
Other Name: Heptavalent Streptoccus pneumonia; Prevenar
Biological: MMR
IM injection of 1 dose of MMR obtained by extemporaneous mixing was offered at 13 months.
Other Name: measles, mumps, and rubella vaccine
Biological: Hib
IM injection of 1 dose of Hib, supplied in pre-filled syringe was offered at 13 months.
Other Name: Vaxem Hib
Experimental: MenACWY-DTaP/DTaP-Hib-IPV/PCV/MMR (III)
MenACWY-CRM together with a course of DTaP-Hib-IPV, and a course of PCV. MMR and a booster dose of Hib were also offered at varying schedules.
Biological: MenACWY-CRM
IM injections of MenACWY conjugate vaccine supplied as an extemporaneous mixing were offered at 2, 4, and 12-month course.
Biological: DTaP-Hib_IPV
IM injection of 3 doses of DTaP-Hib-IPV supplied in prefilled vial were offered at 2, 3, and 4-month course.
Other Name: combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine; Pediacel
Biological: PCV
IM injection of 3 doses of PCV supplied in pre-filled syringe containing a single dose were offered at 2, 4, and 12 or 13-month course.
Other Name: Heptavalent Streptoccus pneumonia; Prevenar
Biological: MMR
IM injection of 1 dose of MMR obtained by extemporaneous mixing was offered at 13 months.
Other Name: measles, mumps, and rubella vaccine
Biological: Hib
IM injection of 1 dose of Hib, supplied in pre-filled syringe was offered at 13 months.
Other Name: Vaxem Hib

  Eligibility

Ages Eligible for Study:   56 Days to 86 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy infants aged 2 months (56 - 83 days old, inclusive)
  • mother available for blood draw at Visit 1

Exclusion Criteria:

  • With known hypersensitivity to any vaccines contained within the routine immunization schedule.
  • With unacceptable concurrent illnesses or conditions - e.g.: a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; a genetic anomaly, e.g. Down's syndrome; any immunodeficiency, including use of systemic corticosteroids; born at less than 36 weeks gestation; weighing less than 2.5 kg at birth; previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease; known bleeding diathesis, or any condition associated with a prolonged bleeding time;
  • Who have received any prohibited prior or concomitant medications - e.g.: any immunizations within the 30 days prior to enrollment, with the exception of BVG or hepatitis B; immunoglobulin; any blood products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488683

Locations
United Kingdom
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00488683     History of Changes
Other Study ID Numbers: V59P16, 2006-003476-35
Study First Received: June 19, 2007
Last Updated: October 16, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Meningococcal disease
Prevention
Vaccination

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

ClinicalTrials.gov processed this record on July 31, 2014