Clinical trial NCT00548171: Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
Official title: Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acellular Pertussis
Tetanus
Diphtheria
Diphtheria-Tetanus-acellular Pertussis Vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 203
Sex: ALL
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No new recruitment will be performed in this booster phase (see inclusion criteria).


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/002 .
* A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/002.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of booster vaccination.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) 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
* Previous booster vaccination against diphtheria, tetanus or pertussis since the last dose received in study 263855/002
* History of diphtheria, tetanus, or pertussis diseases.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
* 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 7 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 3 days of vaccination.
* Acute disease at the time of enrolment.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL)
timeFrame: One month after the booster vaccination [PI(M1)]
Secondary outcomes:
measure: Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
measure: Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
timeFrame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
measure: Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values
timeFrame: Prior (PRE) to booster vaccination
measure: Anti-DT and Anti-TT Antibody Concentrations
timeFrame: Prior to the booster vaccination
measure: Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
timeFrame: Prior the booster vaccination
measure: Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
timeFrame: Prior the booster vaccination
measure: Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
timeFrame: Prior the booster vaccination
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Prior the booster vaccination
measure: Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.
timeFrame: Prior to the booster vaccination
measure: Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.
timeFrame: Prior to the booster vaccination
measure: Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
timeFrame: One month after the booster vaccination
measure: Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
timeFrame: One month after the booster vaccination
measure: Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
timeFrame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
measure: Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
timeFrame: One month after the booster vaccination
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after booster vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period after booster vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period after booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Following the booster vaccination
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Booy R, Van der Meeren O, Ng SP, Celzo F, Ramakrishnan G, Jacquet JM. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine. 2010 Dec 10;29(1):45-50. doi: 10.1016/j.vaccine.2010.10.025. Epub 2010 Oct 23.
citation: Booy R et al. The decennial administration of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (dTpa; BoostrixTM) in adults. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
citation: Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
citation: Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
citation: Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.