Clinical trial NCT01147900: Evaluation of Boostrix™10 Years After Previous Booster Vaccination
Official title: Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Keywords: Immune persistence
Boostrix
dTpa booster study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate study (see reference).

Detailed description: All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.
* Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
* Healthy subjects as established by medical history and clinical examination.
* Female subjects of non-childbearing potential may receive the booster vaccine.
* Female subjects of childbearing potential may receive the booster vaccine, if the subject:

  * practices/has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * agrees to continue adequate contraception during the entire booster epoch.

Exclusion Criteria:

Exclusion criteria to be checked at study entry:

* Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
* History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
* Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :

  * hypersensitivity reaction to any component of the vaccine,
  * encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
  * fever \>= 40 °C (axillary temperature) within 48 hours of vaccination not due to another identifiable cause,
  * collapse or shock-like state within 48 hours of vaccination,
  * convulsions with or without fever, occurring within three days of vaccination.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Additional exclusion criteria to be checked for subjects before the booster vaccination administration:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period.
* 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 product.
* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.
  * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphtheria and Tetanus
timeFrame: At Year 8.5
measure: Concentrations for Anti-D and Anti-T Antibodies.
timeFrame: At Year 8.5
measure: Number of Seroprotected Subjects Against Diphtheria and Tetanus.
timeFrame: At Year 10
measure: Concentrations for Anti-D and Anti-T Antibodies.
timeFrame: At Year 10
measure: Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
timeFrame: At Year 8.5
measure: Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
timeFrame: At Year 8.5
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
timeFrame: At Year 10
measure: Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
timeFrame: At Year 10
measure: Number of Seroprotected Subjects Against Diphtheria and Tetanus
timeFrame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
measure: Concentrations for Anti-D and Anti-T Antibodies.
timeFrame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
timeFrame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
measure: Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
timeFrame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
measure: Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
timeFrame: At 1 month post Year 10 booster vaccination
Secondary outcomes:
measure: Number of Subjects With Any Solicited Local Symptoms.
timeFrame: During the 4-day (Days 0-3) follow-up period after booster vaccination
measure: Number of Subjects With Any Solicited General Symptoms.
timeFrame: During the 4-day (Days 0-3) follow-up period after booster vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs).
timeFrame: During the 31-day (Days 0-30) follow-up period after booster vaccination
measure: Number of Subjects With Any Serious Adverse Events (SAEs).
timeFrame: At Year 8.5
measure: Number of Subjects With Any Serious Adverse Events (SAEs).
timeFrame: From Year 8.5 up to study end (one month post Year 10 booster vaccination)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vandermeulen C, Theeten H, Rathi N, Kuriyakose S, Han HH, Sokal E, Hoppenbrouwers K, Van Damme P. Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Vaccine. 2015 Jun 12;33(26):3026-34. doi: 10.1016/j.vaccine.2014.10.049. Epub 2015 Jan 19.