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Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa

NCT01819155 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2013-10-22

No results posted yet for this study

Summary

This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.

Conditions

Interventions

BIOLOGICAL

Adjuvanted seasonal trivalent inactivated influenza vaccine

BIOLOGICAL

Seasonal trivalent inactivated influenza vaccine

BIOLOGICAL

Saline (bacteriostatic 0.9% sodium chloride for injection)

Sponsors & Collaborators

Principal Investigators

  • Aldiouma Diallo, MD · Institut de Recherche pour le Developpement

  • John C Victor, PhD, MPH · PATH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Senegal

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819155 on ClinicalTrials.gov