A Phase II, Open Label Study to Describe Immune & Transcriptional Responses to MF59 Adjuvanted Trivalent Influenza Vaccine (ATIV) in Healthy 13-24 Month Children and Adults 18-65 Years

NCT02529904 Phase 2 COMPLETED

Influenza infection is related to significant morbidity and mortality in children. The trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is unable to be administered to children under 2 years old. The MF59 adjuvanted influenza vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza, including in children. The study aims to assess early gene transcriptional responses to priming and boosting with MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish correlations with haemagglutination inhibition (HAI) titers. It will be an open label study with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults allocated to group 4.

Details

Lead sponsor	University of Oxford
Phase	Phase 2
Status	COMPLETED
Enrolment	120
Start date	2015-08
Completion	2016-04

Conditions

• Influenza

Interventions

• MF59 - ATIV

Primary outcomes

• Early gene transcriptional responses to immunization with MF59-ATIV — 113 days
  Differential gene expression following ATIV baseline and days 1 and 3 post initial immunisation (adults and children) and at the baseline and day 1 and 3 post boots immunization (children). Gene expression analysis will be done using pax gene tubes for isolation of RNA
• Relationship between early gene transcriptional responses and haemagglutination inhibition (HAI) responses — 113 days
  HAI titers and HAI geometric mean titers (GMT) and the mean geometric increase in HAI at baseline and day 28 (adults and childrens) and day 56 (childrens only). HAI titers thresholds defined as: influenza A H1N1 \>= 1:40; influenza A H3N2 \>=1:110; influenza b \>= 1:620.

Countries

United Kingdom