CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 448 enrolled
Drug / intervention
Boostrixbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03311659
NCT03311659Phase 3Completed
CompareCT.gov

Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' dTpa Booster Vaccine (263855) (Boostrix) Administered as a Booster Dose in Healthy Russian Subjects

GlaxoSmithKline·interventional·Posted Oct 17, 2017·Updated Oct 27, 2020

In Brief

A Phase 3 clinical trial evaluating Boostrix for Diphtheria-Tetanus-acellular Pertussis Vaccines. Completed, enrolled 448 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria-Tetanus-acellular Pertussis Vaccines
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 17, 2017
Enrollment StartJan 26, 2018
Primary CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.7 years ago

Interventions

Boostrixbiological

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