Phase 3
N=1,072
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Meningococcal Disease · Meningococcal Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT00329901 ↗Enrolled (actual)
1,072
Serious AEs
0.3%
Results posted
Jun 2014
Primary outcome: Primary: 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 — 4; 5; 94; 85 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal ACWY conjugate vaccine (MenACWY-CRM) (Biological); Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap) (Biological); saline placebo (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
4; 5; 94; 85; 25; 36 | — |
| SECONDARY 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 |
55; 63; 100; 100; 97; 97 | — |
| SECONDARY 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 |
0.11; 0.12; 7.96; 2.77; 0.62; 0.75 | — |
| SECONDARY 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 |
72; 22; 19; 20; 23; 28 | — |
| SECONDARY 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 |
3; 5; 79; 83; 36; 30 | — |
| SECONDARY 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 |
2.14; 2.21; 34; 50; 4; 3.92 | — |
| SECONDARY 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 |
16; 23; 22; 23; 6.9; 8.09 | — |
| SECONDARY Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo |
74; 80; 82; 78; 58; 59 | — |
| SECONDARY 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 |
278; 179; 82; 116; 48; 66 | — |
| SECONDARY 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 |
278; 282; 227; 246; 103; 103 | — |
| SECONDARY 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 |
43; 31; 48; 8; 6; 6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00329901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.