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:
Novartis Vaccines
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
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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:
MedlinePlus related topics:
Diphtheria
Flu
Haemophilus Infections
Memory
Meningococcal Infections
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
U.S. FDA Resources
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
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 June 17, 2013