CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 235 enrolled
Drug / intervention
Infanrix-IPV/Hibbiological
Likely dose
Infanrix-IPV/Hib administered intramuscularly into the upper thigh at 3, 4.5, and 6 months of age (primary series) and 18 months of age (booster); specific dose not specifiedAI-extracted
Key inclusion· 5
  • ✓Healthy male or female child between 3 and 4 months of age at first vaccination
  • ✓Born full-term
  • ✓Parent(s)/Legally Acceptable Representative able and willing to comply with protocol requirements
  • ✓Written informed consent from parent(s)/LARs prior to study procedures
Key exclusion· 17
  • ✕Child in care
  • ✕Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, or Hib diseases
  • ✕History of diphtheria, tetanus, pertussis, poliomyelitis, or Hib diseases
  • ✕Any confirmed or suspected immunosuppressive or immunodeficient condition

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

Search/NCT02858440
NCT02858440Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus and Haemophilus Influenzae Type b (DTPa-IPV/Hib) Conjugate Vaccine

GlaxoSmithKline·interventional·Posted Aug 8, 2016·Updated Sep 24, 2019

In Brief

A Phase 3 clinical trial evaluating Infanrix-IPV/Hib for Diphtheria and 4 related conditions. Completed, enrolled 235 participants across 5 sites.

Detailed Summary

The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 8, 2016
Enrollment StartSep 13, 2016
Primary CompletionOct 24, 2017
Study CompletionNov 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.9 years ago

Interventions

Infanrix-IPV/Hibbiological

Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.