Evaluation of Boostrix™10 Years After Previous Booster Vaccination

NCT01147900 | Completed Phase 4 Results

• 1 other identifier: 113055
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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).

Conditions

Acellular Pertussis; Tetanus; Diphtheria

Keywords

Immune persistence; Boostrix; dTpa booster study

Outcome Measures

Primary Outcomes (13)

• Number of Seroprotected Subjects Against Diphtheria and Tetanus

  A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

  At Year 8.5

• Concentrations for Anti-D and Anti-T Antibodies.

  Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

  At Year 8.5

• Number of Seroprotected Subjects Against Diphtheria and Tetanus.

  A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

  At Year 10

• Concentrations for Anti-D and Anti-T Antibodies.

  Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

  At Year 10

• Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.

  A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  At Year 8.5

• Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.

  Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.

  At Year 8.5

• Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.

  A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  At Year 10

• Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.

  Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

  At Year 10

• Number of Seroprotected Subjects Against Diphtheria and Tetanus

  A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).

  At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

• Concentrations for Anti-D and Anti-T Antibodies.

  Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.

  At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

• Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.

  A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).

  At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

• Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.

  Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.

  At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)

• Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.

  A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/\< 5 EL.U/mL.

  At 1 month post Year 10 booster vaccination

Secondary Outcomes (5)

• Number of Subjects With Any Solicited Local Symptoms.

  During the 4-day (Days 0-3) follow-up period after booster vaccination

• Number of Subjects With Any Solicited General Symptoms.

  During the 4-day (Days 0-3) follow-up period after booster vaccination

• Number of Subjects With Any Unsolicited Adverse Events (AEs).

  During the 31-day (Days 0-30) follow-up period after booster vaccination

• Number of Subjects With Any Serious Adverse Events (SAEs).

  At Year 8.5

• Number of Subjects With Any Serious Adverse Events (SAEs).

  From Year 8.5 up to study end (one month post Year 10 booster vaccination)

Study Arms (3)

Boostrix-REF Group

EXPERIMENTAL

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Boostrix™

Boostrix-US Group

EXPERIMENTAL

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Boostrix™-US formulation

Boostrix-INV Group

EXPERIMENTAL

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Boostrix™

Interventions

Boostrix™ BIOLOGICAL

Intramuscular, single dose

Boostrix-INV Group; Boostrix-REF Group

Boostrix™-US formulation BIOLOGICAL

Intramuscular, single dose

Boostrix-US Group

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• 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.

  PMID: 25613716 DERIVED

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.

MeSH Terms

Conditions

Tetanus; Diphtheria

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: June 22, 2010
• Study Start: June 15, 2010
• Primary Completion: May 8, 2012
• Study Completion: May 8, 2012
• Last Updated: August 20, 2018
• Results First Posted: October 8, 2013

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

BE (3)