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

NCT03311659 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2020-10-27

Study results available
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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

Interventions

BIOLOGICAL

Boostrix

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-26
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311659 on ClinicalTrials.gov