Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

NCT ID: NCT00635128

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-01
• Study Completion Date: 2008-07-08

Brief Summary

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

Conditions

Poliomyelitis; Diphtheria; Tetanus; Acellular Pertussis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BOOSTRIX-POLIO GROUP

Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Boostrix-Polio

Intervention Type: BIOLOGICAL

A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

BOOSTRIX + IPV MÉRIEUX GROUP

Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Boostrix-Polio

Intervention Type: BIOLOGICAL

A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

Interventions

Boostrix-Polio

A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
• Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressant 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 vaccination, or planned administration during 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 tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
• History of diphtheria, tetanus, pertussis, or poliomyelitis 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 immunoglobulin 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 events (AEs) 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 within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
• Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
• Acute disease at the time of enrolment.
• Pregnant or lactating female.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

GSK Investigational Site

Cham, Bavaria, Germany

GSK Investigational Site

Kaufering, Bavaria, Germany

GSK Investigational Site

Landshut, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Olching, Bavaria, Germany

GSK Investigational Site

Weilheim, Bavaria, Germany

GSK Investigational Site

Eschwege, Hesse, Germany

GSK Investigational Site

Koenigstein, Hesse, Germany

GSK Investigational Site

Salzgitter, Lower Saxony, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Erkrath, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Gütersloh, North Rhine-Westphalia, Germany

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

Countries

Germany

References

Knuf M et al. The repeated administration of a reduced antigen content diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (dTpa-IPV; BoostrixTM IPV) in adolescents. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.

Reference Type: BACKGROUND

Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother. 2012 Jul;8(7):866-72. doi: 10.4161/hv.20229. Epub 2012 Apr 9.

Reference Type: BACKGROUND

PMID: 22485049 (View on PubMed)

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.

Reference Type: BACKGROUND

Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.

Reference Type: BACKGROUND

Knuf M, Vetter V, Celzo F, Ramakrishnan G, Van Der Meeren O, Jacquet JM. Repeated administration of a reduced-antigen-content diphtheria-tetanus-acellular pertussis and poliomyelitis vaccine (dTpa-IPV; Boostrix IPV). Hum Vaccin. 2010 Jul;6(7):554-61. doi: 10.4161/hv.6.7.11760.

Reference Type: DERIVED

PMID: 20448468 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

110947

Identifier Type: -

Identifier Source: org_study_id