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Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00489970
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : August 11, 2010
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study.

This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).


Condition or disease Intervention/treatment Phase
Acellular Pertussis Tetanus Diphtheria Procedure: Taking of blood samples Biological: Boostrix Biological: Adacel Phase 3

Detailed Description:

Subjects were previously vaccinated with either Boostrix or a control Tdap vaccine (Sanofi Pasteurs' Adacel) in study NCT00346073. Only subjects who were part of the primary study will be invited to participate in this study. All subjects will receive a single dose of Boostrix at Visit 6 (Day 0) and subjects will be observed till Visit 7 (Day 30) for safety in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). A blood sample will be collected from all subjects before vaccination (Visit 6) and one month after vaccination (Visit 7) for antibodies estimation.

This summary has been updated following Protocol amendment 1 dated 09 November 2010, amendment 2 dated 18 February 2014, and amendment 3 dated 10 December 2014. The protocol was amended first due to the following reasons:

  1. The maximum window period allowed for the return of subjects for the Year 5 and Year 10 follow-up visits (Visit 5 and Visit 6) was extended from ± 5 weeks to ± 8 weeks.
  2. The contact details for reporting of SAEs were clarified.
  3. Text pertaining to the reporting of spontaneous abortion was removed from the protocol.
  4. The number of attempts to contact subjects who did not return for scheduled persistence visits was clarified.

The main purpose of protocol amendment 2 is to evaluate the immunogenicity and safety of Boostrix as a second dose of Tdap vaccine when administered 8 years after an initial dose of Tdap. The Year 10 time point for evaluation of persistence has been cancelled because it is no longer feasible to conduct after a second dose of Tdap vaccine has been administered at Year 8.

The purpose of amendment 3 is to add co-primary objective to demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix group and Adacel group) is non-inferior to the immune response elicited by a first dose of Tdap vaccine (Control group), with respect to booster response against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens, one month following vaccination according to CBER's input. Accordingly, the study start has been pushed to Year 9 and this is reflected throughout the document.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1954 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Persistence Study of GSK Biologicals' Tdap Vaccine (776423), 1, 3, 5 and 9 Years Following Administration as a Single Dose in NCT00346073 Study and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
Actual Study Start Date : June 1, 2007
Actual Primary Completion Date : September 1, 2011
Actual Study Completion Date : March 1, 2016


Arm Intervention/treatment
Experimental: Boostrix Group
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423).
Procedure: Taking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.

Biological: Boostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.

Active Comparator: Adacel Group
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423).
Procedure: Taking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.

Biological: Boostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.

Biological: Adacel
A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.

Active Comparator: Control group
Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9.
Biological: Boostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.




Primary Outcome Measures :
  1. Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off [ Time Frame: At year 1 after the vaccination in primary study (NCT00346073) ]
    Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)

  2. Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At year 3 after the vaccination in primary study (NCT00346073) ]
    Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA

  3. Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At year 5 after the vaccination in primary study (NCT00346073) ]
    Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA.

  4. Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At Year 9, one month before the booster vaccination. ]
    Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA.

  5. Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At year 1 after the vaccination in primary study (NCT00346073) ]
    Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

  6. Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At year 3 after the vaccination in primary study (NCT00346073) ]
    Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

  7. Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At year 5 after the vaccination in primary study (NCT00346073) ]
    Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

  8. Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off [ Time Frame: At Year 9, one month before the booster vaccination. ]
    Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.

  9. Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL [ Time Frame: At Year 9, one month after the booster vaccination. ]
    Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated

  10. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [ Time Frame: At Year 9, one month before booster vaccination ]
    Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.

  11. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [ Time Frame: At Year 9, one month after the booster vaccination ]
    Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.

  12. Booster Response to D and T Antigens [ Time Frame: At Year 9, one month after the booster vaccination. ]
    A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: < 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.

  13. Booster Response to PT, FHA and PRN Antigens [ Time Frame: At Year 9, one month after the booster vaccination. ]
    Booster response was defined as: for subjects with pre-vaccination antibody concentration < 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL (S+, <4*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative


Secondary Outcome Measures :
  1. Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL).

  2. Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL.

  3. Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.

  4. Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL

  5. Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.

  6. Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL.

  7. Anti-D Antibody Concentration [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.

  8. Anti-D Antibody Concentration [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    Anti-D antibody concentration is expressed as GMC in IU/mL.

  9. Anti-T Antibody Concentration [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    Anti-T antibody concentration is expressed as GMC in IU/mL.

  10. Anti-T Antibody Concentration [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    Anti-T antibody concentration is expressed as GMC in IU/mL.

  11. Anti-PT Antibody Concentration [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    Anti-PT antibody concentration is expressed as GMC in EL.U/mL.

  12. Anti-PT Antibody Concentration [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    Anti-PT antibody concentration was expressed as GMC in IU/mL.

  13. Anti-FHA Antibody Concentration [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    Anti-FHA antibody concentration is expressed as GMC in IU/mL

  14. Anti-FHA Antibody Concentration [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    Anti-FHA antibody concentration was expressed as GMC in IU/mL.

  15. Anti-PRN Antibody Concentration [ Time Frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) ]
    Anti-PRN antibody concentration is expressed as GMC in IU/mL

  16. Anti-PRN Antibody Concentration [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    Anti-PRN antibody concentration is expressed as GMC in IU/mL.

  17. Alternative Booster Response to Anti-D and Anti-T Antigens [ Time Frame: At Year 9, one month after booster vaccination ]
    Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and <1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and <6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration < 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative

  18. Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens [ Time Frame: At Year 9, one month after booster vaccination ]
    Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and < 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative

  19. Seroprotection Status for Anti-D Antibody Concentration [ Time Frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster) ]
    Seroprotection status for anti-D antibody concentration < 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody.

  20. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 [ Time Frame: During the 4-day (Days 0-3) post vaccination period. ]
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm)

  21. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 [ Time Frame: During the 4-day (Days 0-3) post vaccination period. ]
    The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever [defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever > 104.0 degrees F.

  22. Number of Subjects With Any Large Injection Site Reaction - Year 9 [ Time Frame: During the 4-day (Days 0-3) follow-up period after vaccination. ]
    Large injection site reaction = a swelling with a diameter > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference.

  23. Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 [ Time Frame: During the 31-day (Days 0-30) post-vaccination period. ]
    An unsolicited AE covers any untoward medical oc-currence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  24. Number of Subjects With Serious Adverse Events (SAEs) - Year 9 [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   28 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Persistence follow-up phase up to Year 9 time point:

The following criteria are applicable to subjects who refuse vaccination at Year 8 time point:

All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study.

Written informed consent must be obtained from the subject prior to each study time point.

Vaccination phase at Year 9 applicable for subjects in Boostrix and Adacel groups only:

The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix and Adacel groups:

• All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study.

Vaccination phase at Year 9 applicable for subjects in the Control group only:

The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Control group only:

• Subjects within the age range of 28-73 years will be considered eligible to participate in this study in the Control group.

Vaccination phase at Year 9 applicable for ALL subjects (Control, Boostrix and Adacel groups):

The following criteria are applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix, Adacel and Control groups:

All subjects must satisfy the following criteria at study entry at Year 9 time point:

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).

Written informed consent obtained from the subject for vaccination at Year 9 time point.

Healthy subjects as established by medical history and clinical examination before entering into the study.

  • Female subjects of non-childbearing potential may be enrolled in the study.

    • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of child bearing potential may be enrolled in the study, if the subject

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception for 1 month after completion of the vaccine dose

Exclusion Criteria:

The following criteria should be checked at the time of Year 9 vaccination time point. If any criteria is applicable, the subject must not be vaccinated in the study:

For subjects in Boostrix and Adacel groups:

• Administration of Tdap vaccine since the last dose received in the study NCT00346073.

For subjects in the Control group:

• Administration of Tdap (Boostrix or Adacel) vaccine at any time prior to the administration of Boostrix vaccine in this study.

For ALL subjects (Control, Boostrix and Adacel groups):

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period, 31 days (Day 0-30).

  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to Visit 6 (pre-vacc). Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccine, with the exception of inactivated Influenza vaccine which is allowed throughout the study period, 31 days (Day 0-30).

    -- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

  • Hypersensitivity to latex.
  • History of diphtheria, tetanus or pertussis diseases.
  • Severe allergic reaction (e.g. anaphylaxis) after previous administration of any tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any component of Boostrix.
  • History of any neurological disorders or seizures.
  • Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within seven days following previous vaccination with pertussis-containing vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 100.4°F by any route. The preferred route for recording temperature in this study will be oral.
    • Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period, 31 days (Day 0-30).

Administration of any tetanus or diphtheria containing vaccine or any registered or investigational vaccine utilizing a diphtheria toxoid or tetanus toxoid carrier within 5 years prior to the administration of Boostrix vaccine in this study.

  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions during the 31 day (Day 0-30) follow-up period post-vaccination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489970


Locations
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United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Mesa, Arizona, United States, 85203
GSK Investigational Site
Mesa, Arizona, United States, 85213
GSK Investigational Site
Phoenix, Arizona, United States, 85014
GSK Investigational Site
Tempe, Arizona, United States, 85283
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
San Diego, California, United States, 92103-6204
GSK Investigational Site
San Diego, California, United States, 92108
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
GSK Investigational Site
Pueblo, Colorado, United States, 81001
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20006
United States, Florida
GSK Investigational Site
Melbourne, Florida, United States, 32935
GSK Investigational Site
Miami, Florida, United States, 33143
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83704
United States, Illinois
GSK Investigational Site
Peoria, Illinois, United States, 61602
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Michigan
GSK Investigational Site
Richland, Michigan, United States, 49083
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
North Platte, Nebraska, United States, 69101
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Grove City, Pennsylvania, United States, 16127
GSK Investigational Site
Johnstown, Pennsylvania, United States, 15904
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29412
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77024
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00489970    
Other Study ID Numbers: 110080
110082 ( Other Identifier: GSK )
110084 ( Other Identifier: GSK )
110086 ( Other Identifier: GSK )
First Posted: June 22, 2007    Key Record Dates
Results First Posted: August 11, 2010
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=16064
Keywords provided by GlaxoSmithKline:
Persistence
immunogenicity
Additional relevant MeSH terms:
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Diphtheria
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections