Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects

NCT03311659 | Completed Phase 3 Results

• 2 other identifiers: 2015322015-003405-42
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 8

Brief Summary

Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine, administered as a booster dose in healthy Russian subjects. An equal number of subjects are expected to be recruited in the following age categories: 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis diseases.

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Keywords

Diphtheria; Pertussis; Tetanus; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D).

  A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations \<0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.

  At Day 31

• Number of Seroprotected Subjects for Anti-tetanus (Anti-T).

  A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.

  At Day 31

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

  A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.

  At Day 31

Secondary Outcomes (9)

• Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens

  At Day 31

• Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens.

  At Day 31

• Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination.

  At Day 31

• Number of Subjects With Solicited Local Symptoms.

  During the 4-day (Day 1-4) follow-up period after vaccination.

• Number of Subjects Aged Below 6 Years With Solicited General Symptoms.

  During the 4-day (Day 1-4) follow-up period after vaccination.

Study Arms (1)

dTpa group

EXPERIMENTAL

Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1.

Biological: Boostrix

Interventions

Boostrix BIOLOGICAL

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group.

dTpa group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects or subjects' parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female four years of age and older.
• Written informed consent obtained from the subject/from the parent(s)/adoptive parent(s) of the subject prior to performing any study specific procedure.
• Written informed assent obtained from subjects aged 14 years to \<18 years.
• Healthy subjects as established by medical history and physical examination before entering into the study.
• Children 4-7 years of age with documented previous diphtheria, tetanus and pertussis vaccination (primary series and first booster) as per local recommendation prior to study enrolment, but should have not received any further diphtheria-tetanus containing booster planned at 6-7 years of age as per local recommendations or any other diphtheria, tetanus and pertussis containing vaccine.
• Subjects eight years of age and older who can report previous diphtheria, tetanus with or without pertussis vaccination - documented or to the best of their/subjects' parent(s)/subjects' adoptive parent(s) knowledge - and did not receive an additional diphtheria, tetanus with or without pertussis vaccination within five years prior to enrolment in the study will be enrolled.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception within 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the 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 dose of study vaccine, or planned use during the study period.
• History of previous or intercurrent diphtheria, tetanus or pertussis diseases since birth in subjects four to seven years of age.
• History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5 years prior to enrolment in subjects aged eight years and above.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), or equivalent. Inhaled and topical steroids are allowed
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccine with the exception of inactivated influenza vaccine which can be given at any time during the study conduct as per the Summary of Product Characteristics (SPC) and according to the local governmental recommendations.
• 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 vaccine/product (pharmaceutical product or device).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• History of encephalopathy after administration of a previous dose of pertussis vaccine that could not be attributed to another identifiable cause, progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilised.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature in this study will be the axilla.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Barnaul, 656056, Russia

Location

GSK Investigational Site

Gatchina, 188300, Russia

Location

GSK Investigational Site

Moscow, 115478, Russia

Location

GSK Investigational Site

Moscow, 129515, Russia

Location

GSK Investigational Site

Murmansk, 183038, Russia

Location

GSK Investigational Site

Saint Petersburg, 191025, Russia

Location

GSK Investigational Site

Yaroslavl, 150051, Russia

Location

GSK Investigational Site

Yekaterinburg, 620137, Russia

Location

Related Publications (1)

• Asatryan A, Meyer N, Scherbakov M, Romanenko V, Osipova I, Galustyan A, Shamsheva O, Latysheva T, Myasnikova T, Baudson N, Dodet M, Xavier S, Harrington L, Kuznetsova A, Campora L, Van den Steen P. Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study. Hum Vaccin Immunother. 2021 Mar 4;17(3):723-730. doi: 10.1080/21645515.2020.1796423. Epub 2020 Aug 26.

  PMID: 32845735 BACKGROUND

MeSH Terms

Conditions

Diphtheria; Whooping Cough; Tetanus

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The treatment allocation would be non-randomised and stratified by age into four strata \[4-9 years (children), 10-17 years (adolescents), 18-64 (adults) years and ≥65 years (elderly population)\].
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 17, 2017
• Study Start: January 26, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 27, 2020
• Results First Posted: October 23, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

RU (8)