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Phase 3 Completed N=1,592 Randomized Prevention

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

Acellular Pertussis · Tetanus · Diphtheria
Source: ClinicalTrials.gov NCT00489970 ↗
Enrolled (actual)
1,592
Serious AEs
0.1%
Results posted
Aug 2010
Primary outcomePrimary: Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off — 967; 489 Participants

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off
967; 489
PRIMARY
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
245; 113
PRIMARY
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
245; 113
PRIMARY
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
245; 113
PRIMARY
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off
1000; 504
PRIMARY
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
263; 120
PRIMARY
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
263; 120
PRIMARY
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
263; 120
PRIMARY
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
245; 113; 265; 263; 120; 304
PRIMARY
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
64.1; 70.4; 247.9; 254.6; 405.4; 511.8
PRIMARY
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
64.1; 70.4; 247.9; 254.6; 405.4; 511.8
PRIMARY
Booster Response to D and T Antigens
16; 3; 35; 153; 68; 187
PRIMARY
Booster Response to PT, FHA and PRN Antigens
34; 10; 101; 106; 53; 94
SECONDARY
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
917; 435; 751; 316; 670; 285
SECONDARY
Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off
230; 106; 209; 268; 120; 322
SECONDARY
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
271; 119; 322; 271; 121; 327
SECONDARY
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
271; 119; 322; 271; 121; 327
SECONDARY
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
267; 117; 284; 271; 121; 326
SECONDARY
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
267; 117; 284; 271; 121; 326
SECONDARY
Anti-D Antibody Concentration
0.7; 0.8; 0.4; 4.1; 4.7; 4.0
SECONDARY
Anti-D Antibody Concentration
0.7; 0.8; 0.4; 4.1; 4.7; 4.0
SECONDARY
Anti-T Antibody Concentration
1.8; 2.3; 1.5; 8.4; 8.6; 8.8
SECONDARY
Anti-T Antibody Concentration
1.8; 2.3; 1.5; 8.4; 8.6; 8.8
SECONDARY
Anti-PT Antibody Concentration
8.2; 7.8; 5.4; 64.1; 70.4; 66.2
SECONDARY
Anti-PT Antibody Concentration
8.2; 7.8; 5.4; 64.1; 70.4; 66.2
SECONDARY
Anti-FHA Antibody Concentration
42.2; 28.4; 23.6; 247.9; 254.6; 373.6
SECONDARY
Anti-FHA Antibody Concentration
42.2; 28.4; 23.6; 247.9; 254.6; 373.6
SECONDARY
Anti-PRN Antibody Concentration
63.8; 64.7; 17.8; 405.4; 511.8; 336.4
SECONDARY
Anti-PRN Antibody Concentration
63.8; 64.7; 17.8; 405.4; 511.8; 336.4
SECONDARY
Alternative Booster Response to Anti-D and Anti-T Antigens
16; 3; 35; 103; 45; 148
SECONDARY
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
1; 5; 171; 91; 241; 82
SECONDARY
Seroprotection Status for Anti-D Antibody Concentration
8.3; 40.0; 27.6; 50.0; 0.0; 14.3
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
180; 84; 132; 3; 1; 4
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
71; 23; 51; 3; 1; 0
SECONDARY
Number of Subjects With Any Large Injection Site Reaction - Year 9
0; 0; 0
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9
42; 23; 37
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs) - Year 9
0; 0; 1

Eligibility 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,
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00489970). 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. Informational only — not medical advice.

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