CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 292 enrolled
Drug / intervention
Squarekids +1 morebiological
Likely dose
Squarekids: three doses subcutaneously; Rotarix: two doses orallyAI-extracted
Key inclusion· 4
  • ✓Age 6–12 weeks at first HRV vaccine dose
  • ✓Healthy as established by medical history and clinical examination
  • ✓Born full-term per delivery records
  • ✓Parent(s)/legally acceptable representative able to comply with protocol requirements
Key exclusion· 14
  • ✕Child in care
  • ✕Use of investigational or non-registered product within 30 days before first dose of study vaccine
  • ✕Chronic immunosuppressants or immune-modifying drugs since birth (corticosteroids ≥0.5 mg/kg/day prednisone equivalent)
  • ✕Administration of immunoglobulins or blood products since birth

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

Search/NCT02907216
NCT02907216Phase 4Completed
CompareCT.gov

Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants

GlaxoSmithKline·interventional·Posted Sep 20, 2016·Updated Nov 25, 2019

In Brief

A Phase 4 clinical trial evaluating Squarekids and Rotarix for Rotavirus. Completed, enrolled 292 participants across 11 sites.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since 2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been evaluated during the clinical development of the HRV vaccine, the vaccine differed in composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when co-administered with the liquid HRV vaccine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 20, 2016
Enrollment StartSep 16, 2016
Primary CompletionMay 29, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.8 years ago

Interventions

Squarekidsbiological

Three doses administered subcutaneously in the upper arm or thigh

Rotarixbiological

Two doses administered orally