Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

Browse trials for

• Diphtheria 265

Keywords

• dTpa
• Boostrix

Diphtheria

265 studies on the registry are indexed under Diphtheria; 16 are open to participants now.

This study's enrollment of 671 is above the median of 440 across 239 interventional studies indexed under Diphtheria.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  BOOSTRIX NEW GROUP

  Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.

  Biological: Boostrix TM (new syringe presentation)

• Active comparator
  BOOSTRIX PREV GROUP

  Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.

  Biological: Boostrix TM (previous syringe presentation)

Interventions

• BiologicalBoostrix TM (new syringe presentation)

  Single dose, intramuscular administration in a new syringe presentation

• BiologicalBoostrix TM (previous syringe presentation)

  Single dose, intramuscular administration in previous syringe presentation

Primary outcomes

1. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

   Time frame: At Month 1

2. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)

   Time frame: At Month 1

3. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

   Time frame: At Day 0

4. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

   Time frame: At Day 0

Secondary outcomes

1. Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens

   A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).

   Time frame: At Day 0 (PRE) and at Month 1 (POST)

2. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens

   A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).

   Time frame: At Day 0 (PRE) vaccine and at Month 1 (POST)

3. Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)

   A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

   Time frame: At Day 0 (PRE) vaccine and at Month 1 (POST)

4. Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies

   Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration \<0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.

   Time frame: At Month 1

5. Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.

   Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); for initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.

   Time frame: At Month 1

6. Number of Subjects With Any Solicited Local Symptoms

   Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

   Time frame: Within 4 days (Days 0-3) post vaccination period

7. Number of Subjects With Unsolicited Adverse Events (AEs)

   An unsolicited AE covers any untoward medical occurrence 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

   Time frame: Within 31 days (Days 0-30) post

8. Number of Subjects With Any Solicited General Symptoms

   Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.

   Time frame: Within 4 days (Days 0-3) post vaccination period

9. Number of Subjects With Serious Adverse Events (SAEs)

   Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

   Time frame: During the entire study period (Day 0 - Month 1)

Baseline characteristics

Publications

• Pavia-Ruz N, Abarca K, Lepetic A, Cervantes-Apolinar MY, Hardt K, Jayadeva G, Kuriyakose S, Han HH, de la O M. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial. Hum Vaccin Immunother. 2015;11(7):1770-4. doi: 10.1080/21645515.2015.1041697. PubMed 26075317 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.