Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers
2 other identifiers
interventional
662
1 country
28
Brief Summary
The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2008
Typical duration for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
November 7, 2013
CompletedNovember 7, 2013
September 1, 2013
1.3 years
April 24, 2008
February 18, 2013
September 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C
Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.
1 month postvaccination
Secondary Outcomes (17)
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C
1 month postvaccination
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y
1 month postvaccination.
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y
1 month postvaccination.
Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C
1 month postvaccination
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y
1 month postvaccination
- +12 more secondary outcomes
Study Arms (3)
MenACWY-CRM197 (2 doses) + Concomitant Vaccines
EXPERIMENTALInfants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months.
MenACWY-CRM197 (1 dose) + Concomitant Vaccines
EXPERIMENTALInfants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.
MenC (1 dose) + Concomitant Vaccines
ACTIVE COMPARATORInfants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.
Interventions
Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
One 0.5mL dose of MenC vaccine was administered by intramuscular injection.
One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
Eligibility Criteria
You may qualify if:
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry
You may not qualify if:
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Site 22
Bad Kreuznach, 55543, Germany
Site 38
Bad Lobenstein, 07356, Germany
Site 24
Balve, 58802, Germany
Site 3
Berlin, 12589, Germany
Site 27
Berlin, 12619, Germany
Site 20
Berlin, 12627, Germany
Site 26
Berlin, 12627, Germany
Site 13
Berlin, 13189, Germany
Site 31
Berlin, 13189, Germany
Site 25
Berlin, 13347, Germany
Site 15
Bönnigheim, 74357, Germany
Site 39
Eschwege, 37269, Germany
Site 32
Flensburg, 24937, Germany
Site 16
Frankenthal, 67227, Germany
Site 33
Glücksburg, 24960, Germany
Site 35
Hamburg, 22147, Germany
Site 2
Kehl, 77694, Germany
Site 28
Mainz, 55127, Germany
Site 44
Mainz, 55131, Germany
Site 43
München-Ramersdorf, 81669, Germany
Site 42
Neuhaus am Rennweg, 98724, Germany
Site 21
Neumünster, 24534, Germany
Site 9
Neumünster, 24534, Germany
Site 10
Oberstenfeld, 71720, Germany
Site 4
Stuttgart, 70193, Germany
Site 19
Stuttgart, 70469, Germany
Site 30
Weilheim I OB, 82362, Germany
Site 6
Wiesloch, 69168, Germany
Related Publications (1)
Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.
PMID: 33325757DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
GCP compliance issues were identified at one site, data collected for this site were not used in this data posting.
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2009
Study Completion
October 1, 2010
Last Updated
November 7, 2013
Results First Posted
November 7, 2013
Record last verified: 2013-09