Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, or One Dose of Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years
2 other identifiers
interventional
1,072
1 country
14
Brief Summary
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2006
14 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
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 23, 2006
CompletedFirst Posted
Study publicly available on registry
May 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
June 18, 2014
CompletedJune 18, 2014
June 1, 2014
1.1 years
May 23, 2006
August 27, 2013
June 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
1 month after vaccination (Day 29)
Secondary Outcomes (10)
Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
1 month after vaccination (Day 29)
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
1 month after vaccination (Day 29)
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
1 month after vaccination (Day 29)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
1 month after vaccination (Day 29)
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
1 month after vaccination (Day 29)
- +5 more secondary outcomes
Study Arms (3)
Tdap + MenACWY-CRM
EXPERIMENTALSubjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
Tdap + saline
EXPERIMENTALSubjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
MenACWY-CRM + saline
EXPERIMENTALSubjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Interventions
Eligibility Criteria
You may qualify if:
- Male and female 11-25 years old healthy subjects;
- who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry
You may not qualify if:
- previous ascertained or suspected disease caused by N. meningitidis
- previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- serious acute, chronic or progressive disease
- history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
- known or suspected impairment/alteration of immune function, either congenital or acquired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Andria, Italy
Unknown Facility
Catania, Italy
Unknown Facility
Chieti, Italy
Unknown Facility
Ferrara, Italy
Unknown Facility
Genova, Italy
Unknown Facility
Lanciano, Italy
Unknown Facility
Massafra, Italy
Unknown Facility
Modena, Italy
Unknown Facility
Novara, Italy
Unknown Facility
Palermo, Italy
Unknown Facility
Pieve Di Soligo (TV), Italy
Unknown Facility
Roma, Italy
Unknown Facility
Sassari, Italy
Unknown Facility
Taranto, Italy
Related Publications (1)
Gasparini R, Conversano M, Bona G, Gabutti G, Anemona A, Dull PM, Ceddia F. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol. 2010 Apr;17(4):537-44. doi: 10.1128/CVI.00436-09. Epub 2010 Feb 17.
PMID: 20164251RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines - Information Services
Novartis Vaccines & Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2006
First Posted
May 25, 2006
Study Start
April 1, 2006
Primary Completion
May 1, 2007
Study Completion
December 1, 2007
Last Updated
June 18, 2014
Results First Posted
June 18, 2014
Record last verified: 2014-06