Clinical trial NCT00329901: Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningitis
healthy subject
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 1072
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 1 month after vaccination (Day 29)
Secondary outcomes:
measure: 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
timeFrame: 1 month after vaccination (Day 29)
measure: 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
timeFrame: 1 month after vaccination (Day 29)
measure: 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
timeFrame: 1 month after vaccination (Day 29)
measure: 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
timeFrame: 1 month after vaccination (Day 29)
measure: 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
timeFrame: 1 month after vaccination (Day 29)
measure: Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
timeFrame: 1 month after vaccination (Day 29)
measure: Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
timeFrame: 1 month after vaccination (Day 29)
measure: Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
timeFrame: Day 1-7 after any vaccination
measure: Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
timeFrame: Day 1-7 after any vaccination
measure: Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
timeFrame: Throughout the study (Day 1 to Day 181)
Other outcomes:
Locations:
city: Andria
country: Italy
city: Catania
country: Italy
city: Chieti
country: Italy
city: Ferrara
country: Italy
city: Genova
country: Italy
city: Lanciano
country: Italy
city: Massafra
country: Italy
city: Modena
country: Italy
city: Novara
country: Italy
city: Palermo
country: Italy
city: Pieve di Soligo (TV)
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Taranto
country: Italy
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines - Information Services
role: STUDY_CHAIR
References:
citation: 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.