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

NCT01362322 | Completed Phase 4 Results

• 1 other identifier: 114778
• Study Type: interventional
• Target: 671
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.

Conditions

Diphtheria; Tetanus; Acellular Pertussis

Keywords

dTpa; Boostrix

Outcome Measures

Primary Outcomes (4)

• 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).

  At Month 1

• 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)

  At Month 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).

  At Day 0

• 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).

  At Day 0

Secondary Outcomes (9)

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

  At Day 0 (PRE) and at Month 1 (POST)

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

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

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

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

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

  At Month 1

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

  At Month 1

Study Arms (2)

BOOSTRIX NEW GROUP

EXPERIMENTAL

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)

BOOSTRIX PREV GROUP

ACTIVE COMPARATOR

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

Boostrix TM (new syringe presentation) BIOLOGICAL

Single dose, intramuscular administration in a new syringe presentation

BOOSTRIX NEW GROUP

Boostrix TM (previous syringe presentation) BIOLOGICAL

Single dose, intramuscular administration in previous syringe presentation

BOOSTRIX PREV GROUP

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the investigator believes can and are willing to comply with the requirements of the protocol.
• A male or female between 10 and 15 years of age at the time of booster vaccination.
• Prior to protocol amendment 2, subjects who have previously received 5 doses of diphtheria-tetanus-pertussis vaccine (whole cell/acellular \[w/a\]) as part of primary and booster vaccination, in line with local recommendations.
• After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.
• Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.
• Written informed consent to be obtained before study entry from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative(s), if required by local regulations.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has a negative pregnancy test on the day of vaccination,
• if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine 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.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine - with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose.
• 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.
• A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
• A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months.
• Occurrence of any of the following adverse event after a previous administration of a Boostrix vaccine :
• known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines,
• encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
• transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Santiago, Chile

Location

GSK Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

GSK Investigational Site

Estado de México, 55075, Mexico

Location

Related Publications (1)

• 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.

  PMID: 26075317 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

Diphtheria; Tetanus

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 30, 2011
• Study Start: July 1, 2011
• Primary Completion: September 3, 2012
• Study Completion: September 3, 2012
• Last Updated: August 10, 2018
• Results First Posted: August 10, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

ME (2); CL (1)