B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
A Phase II, Single Center, 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
2 other identifiers
interventional
216
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2007
CompletedFirst Posted
Study publicly available on registry
June 20, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedOctober 1, 2014
September 1, 2014
1.8 years
June 19, 2007
May 30, 2013
September 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y
The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators. Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose). Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y.
1 month after primary vaccination and immediately before third dose at 12 months of age
Secondary Outcomes (19)
Memory B Cells by Serogroup A, C, W-135 and Y
1 month after primary vaccination and immediately before third dose
Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination
1 month after primary vaccination and 1 month after third vaccination
Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination
1 month after primary and pre-third and 1 month after third vaccination
Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y
One month after primary vaccination and 1 week after third vaccination
CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination
5 months (B cells), 12 months and 13 months (B cells and IgG) of age
- +14 more secondary outcomes
Study Arms (3)
MenACWY-CRM and Routine Vaccines (Group 1)
EXPERIMENTALInfants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
MenACWY-CRM and Routine Vaccines (Group 2)
EXPERIMENTALInfants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment.
MenACWY-CRM and Routine Vaccines (Group 3)
EXPERIMENTALInfants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM.
Interventions
One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.
IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.
IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.
IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.
IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.
Eligibility Criteria
You may qualify if:
- Subjects who were eligible to be enrolled in the study:
- healthy infants aged 2 months (56 - 83 days old, inclusive);
- available for the visits scheduled in the study;
- mother available for blood draw at Visit 1;
- good health as determined by the clinical judgement of the investigator;
- whose parents gave written informed consent for the infant to be enrolled in the study. The infant's parents must have been willing for the infant to receive the full primary immunization course.
You may not qualify if:
- Subjects who were not eligible for the study were those:
- whose parents had not given or were unwilling or unable to give written informed consent to their child's participation in the study
- 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 BCG or hepatitis B;
- immunoglobulin;
- any blood products;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Vaccineslead
- Novartiscollaborator
Study Sites (1)
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine
Headington, Oxford, OX3 7LJ, United Kingdom
Related Publications (1)
Blanchard-Rohner G, Snape MD, Kelly DF, O'Connor D, John T, Clutterbuck EA, Ohene-Kena B, Klinger CL, Odrljin T, Pollard AJ. The B-cell response to a primary and booster course of MenACWY-CRM(1)(9)(7) vaccine administered at 2, 4 and 12 months of age. Vaccine. 2013 May 7;31(20):2441-8. doi: 10.1016/j.vaccine.2013.03.036. Epub 2013 Apr 6.
PMID: 23566945RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines and Diagnostics
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2007
First Posted
June 20, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
October 1, 2014
Results First Posted
August 15, 2014
Record last verified: 2014-09