Clinical trial NCT01323959: Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults
Official title: Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acellular Pertussis
Poliomyelitis
Diphtheria
Tetanus
Keywords: BoostrixTM Polio
dTpa-IPV
booster
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-03-28
Enrollment: 212
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.

Detailed description: This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Male or female subjects who have received vaccine in study NCT01277705.
* Written informed consent obtained from the subject.
* 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.
* Female subjects of childbearing potential may be enrolled in the study and 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:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C.
* History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
* 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 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.
* 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.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
timeFrame: At Month 1
measure: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
timeFrame: At Month 1
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
timeFrame: At Day 0
measure: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
timeFrame: At Day 0
measure: Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
timeFrame: At Day 0
measure: Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Day 0
measure: Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
timeFrame: At Day 0
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
timeFrame: At Day 0
Secondary outcomes:
measure: Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
timeFrame: At Month 1
measure: Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
timeFrame: At Month 1
measure: Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Month 1
measure: Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
timeFrame: At Month 1
measure: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
timeFrame: At Month 1
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-Day 3) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 4-day (Day 0-Day 3) follow-up period after vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs).
timeFrame: During the 31-day (Day 0-Day 30) follow-up period after vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs).
timeFrame: Month 0 - Month 1
Other outcomes:
Locations:
city: Derval
country: France
facility: GSK Investigational Site
city: La Chapelle Basse Mer
country: France
facility: GSK Investigational Site
city: La Riche
country: France
facility: GSK Investigational Site
city: Nantes cedex 2
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Deggendorf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoehenkirchen-Siegertsbrunn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Selbitz
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Vilshofen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.