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

NCT ID: NCT01362322

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-01
• Study Completion Date: 2012-09-03

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.

Detailed Description

The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care.

The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.

Conditions

Diphtheria; Tetanus; Acellular Pertussis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

BOOSTRIX NEW GROUP

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.

Group Type: EXPERIMENTAL

Boostrix TM (new syringe presentation)

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration in a new syringe presentation

BOOSTRIX PREV GROUP

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.

Group Type: ACTIVE_COMPARATOR

Boostrix TM (previous syringe presentation)

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration in previous syringe presentation

Interventions

Boostrix TM (new syringe presentation)

Single dose, intramuscular administration in a new syringe presentation

Intervention Type: BIOLOGICAL

Boostrix TM (previous syringe presentation)

Single dose, intramuscular administration in previous syringe presentation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 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

Santiago, , Chile

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Estado de México, , Mexico

Countries

Chile; Mexico

References

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.

Reference Type: DERIVED

PMID: 26075317 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

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

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Document Type: Clinical Study Report

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

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Document Type: Individual Participant Data Set

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

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Document Type: Study Protocol

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

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Document Type: Informed Consent Form

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

View Document

Document Type: Dataset Specification

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

View Document

Related Links

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Other Identifiers

114778

Identifier Type: -

Identifier Source: org_study_id