CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 470 enrolled
Drug / intervention
D-SUIV cH8/1N1+AS03 +10 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.

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Search/NCT03275389
NCT03275389Phase 1Completed
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Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults

GlaxoSmithKline·interventional·Posted Sep 7, 2017·Updated May 7, 2021

In Brief

A Phase 1 clinical trial evaluating D-SUIV cH8/1N1+AS03, D-SUIV cH5/1N1+AS03, and 9 other interventions for Influenza, Human. Completed, enrolled 470 participants across 6 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesBelgium, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedSep 7, 2017
Enrollment StartSep 8, 2017
Primary CompletionMar 26, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.8 years ago

Interventions

D-SUIV cH8/1N1+AS03biological

1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.

D-SUIV cH5/1N1+AS03biological

1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH11/1N1+AS03biological

1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH8/1N1+AS01biological

1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH5/1N1+AS01biological

1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH11/1N1+AS01biological

1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH8/1N1biological

1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH5/1N1biological

1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.

D-SUIV cH11/1N1biological

1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.

Placebobiological

1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.

Fluarix Quadrivalentbiological

1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.