Last updated: 11/03/2018 08:32:13
US-licensed combined vaccine against tetanus & diphtheria, given with US-licensed vaccine against meningococcal disease
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety & immunogenicity of a booster dose of dTPa vaccine (Boostrix®) co-admnd. with Aventis Pasteur’s meningococcal (serogroups A, C, Y and W-135) polysaccharide vaccine (Menactra™) vs admn. of either vaccine alone in healthy adolescents
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Timeframe: At Month 1 (post Boostrix vaccination)
Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
Timeframe: At Month 1 (post Boostrix vaccination)
Number of subjects with booster responses for anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies
Timeframe: At Month 1 (post Boostrix vaccination)
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)
Timeframe: One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)
Secondary outcomes:
Number of subjects with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibodies
Timeframe: At Day 0 (PRE) before Boostrix vaccination
Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Timeframe: At Month 2 (one month post Boostrix vaccination)
Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens
Timeframe: PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Number of subjects with booster responses for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Timeframe: At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations
Timeframe: PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations
Timeframe: At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)
Number of subjects with booster responses for anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies
Timeframe: At Month 2 (one month post Boostrix vaccination)
Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
Timeframe: At Day 0 before (PRE) Boostrix vaccination
Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
Timeframe: At Month 2 (one month post Boostrix vaccination)
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies
Timeframe: PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)
Number of subjects with vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies
Timeframe: At Month 2 (one month after vaccination with Menactra vaccine)
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: Within 4-days (Day 0-3) after each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: Within 4-days (Days 0-3) after each dose and across doses
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within the 31-day (Days 0-30) period after each vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the entire study period (Day 0 - Month 2)
Interventions:
Biological/vaccine: Boostrix®
Biological/vaccine: Menactra™
Enrollment:
1344
Observational study model:
Not applicable
Primary completion date:
2006-08-08
Time perspective:
Not applicable
Clinical publications:
Friedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007
Weston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007
Weston WM et al. (2011) Immunogenicity and reactogenicity of co-administered tetanus-diphtheria-acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration. Vaccine. 29(5):1017-1022.
Medical condition
acellular pertussis, Tetanus, Diphtheria
Product
SB776423
Collaborators
Not applicable
Study date(s)
January 2006 to August 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
11 - 18 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
Location
GSK Investigational Site
Frederick, Maryland, United States, 21702
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84084
Status
Study Complete
Location
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
Status
Study Complete
Location
GSK Investigational Site
University Heights, Ohio, United States, 44118
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Whitehouse Station, New Jersey, United States, 08889
Status
Study Complete
Location
GSK Investigational Site
Pittsford, New York, United States, 14534
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15227
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14620
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Golden, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-08-08
Actual study completion date
2006-08-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website