CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 303 enrolled
Drug / intervention
Boostrix Polio™ 711866 +2 morebiological
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/NCT00871000
NCT00871000Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.

GlaxoSmithKline·interventional·Posted Mar 30, 2009·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Boostrix Polio™ 711866, Priorix Tetra TM 208136, and 1 other intervention for Acellular Pertussis and 3 related conditions. Completed, enrolled 303 participants across 8 sites.

Detailed Summary

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy. In this study, MMRV vaccine will also be co-administered to all children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Tetanus, Diphtheria, Poliomyelitis
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2009
Enrollment StartApr 1, 2009
Primary CompletionNov 18, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.3 years ago

Interventions

Boostrix Polio™ 711866biological

Single dose, intramuscular administration.

Priorix Tetra TM 208136biological

Single dose, subcutaneously.

Tetravac TMbiological

Single dose, intramuscular administration.