Phase 4
N=1,341
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Acellular Pertussis · Tetanus · Diphtheria
Bottom Line
View on ClinicalTrials.gov: NCT00282295 ↗Enrolled (actual)
1,341
Serious AEs
0.2%
Results posted
Mar 2017
Primary outcome: Primary: Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies — 427; 405; 425; 412 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Boostrix® (Biological); Menactra™ (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies |
428; 426 | — |
| PRIMARY Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations |
77.8; 653.0; 412.5 | — |
| PRIMARY Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies |
338; 405; 414 | — |
| PRIMARY Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) |
329; 328; 390; 383; 369; 358 | — |
| SECONDARY Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies |
109; 93; 120; 201; 181; 195 | — |
| SECONDARY Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies |
428; 426 | — |
| SECONDARY Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens |
399; 383; 391; 423; 409; 423 | — |
| SECONDARY Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies |
422; 377; 422; 310; 330; 329 | — |
| SECONDARY Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations |
16.5; 41.6; 10.0; 0.9 | — |
| SECONDARY Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations |
16.5; 41.6; 10.0; 0.9 | — |
| SECONDARY Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies |
338; 405; 414 | — |
| SECONDARY Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations |
77.8; 653.0; 412.5 | — |
| SECONDARY Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations |
77.8; 653.0; 412.5 | — |
| SECONDARY Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies |
533.4; 490.8; 449.4; 10406.1; 7220.0; 9466.3 | — |
| SECONDARY Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies |
300; 351; 325; 360 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
331; 304; 236; 26; 14; 6 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
150; 139; 114; 13; 9; 5 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
124; 149; 155; 16; 15; 22 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
1; 0; 1 | — |
Summary
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.
- Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.
Exclusion Criteria
- Administration of a pre-school booster of DTP vaccine within the previous 5 years
- Administration of a diphteria-tetanus (Td) booster within the previous 5 years
- Previous vaccination against N. meningitidis
- Hypersensitivity to latex
- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines
- History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause
- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized
- Previous history of Guillain-Barré syndrome
Data sourced from ClinicalTrials.gov (NCT00282295). 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.