NCT01819155

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 22, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

March 22, 2013

Last Update Submit

October 18, 2013

Conditions

Influenza

Keywords

influenzainfluenza vaccineimmunogenicityAfricaSenegal

Outcome Measures

Primary Outcomes (2)

  • Immunogenicity of adjTIV

    serum hemagglutination-inhibition antibodies

    28 days post-dose 2

  • Immunogenicity of TIV

    serum hemagglutination-inhibition antibodies

    28 days post-dose 2

Secondary Outcomes (1)

  • Adverse events

    through three months post-dose 2

Study Arms (3)

adjTIV

EXPERIMENTAL

Children randomized to receive adjTIV

Biological: Adjuvanted seasonal trivalent inactivated influenza vaccine

TIV

EXPERIMENTAL

Children randomized to receive TIV

Biological: Seasonal trivalent inactivated influenza vaccine

Placebo

PLACEBO COMPARATOR

Children randomized to receive Placebo

Biological: Saline (bacteriostatic 0.9% sodium chloride for injection)

Interventions

Adjuvanted seasonal trivalent inactivated influenza vaccineBIOLOGICAL
Also known as: Fluad
adjTIV
Seasonal trivalent inactivated influenza vaccineBIOLOGICAL
Also known as: VaxiGrip
TIV
Saline (bacteriostatic 0.9% sodium chloride for injection)BIOLOGICAL
Placebo

Eligibility Criteria

Age6 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
  • Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
  • Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.

You may not qualify if:

  • Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
  • Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
  • Previous receipt of any influenza vaccine.
  • Hypersensitivity after previous administration of any vaccine.
  • Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche pour le Développement

Niakhar, Senegal

Location

Related Publications (1)

  • Diallo A, Victor JC, Feser J, Ortiz JR, Kanesa-Thasan N, Ndiaye M, Diarra B, Cheikh S, Diene D, Ndiaye T, Ndiaye A, Lafond KE, Widdowson MA, Neuzil KM. Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naive children in a randomized clinical trial in rural Senegal. Vaccine. 2018 Oct 15;36(43):6424-6432. doi: 10.1016/j.vaccine.2018.08.032. Epub 2018 Sep 14.

    PMID: 30224199DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

fluad vaccinevaxigripSodium ChlorideInjections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Aldiouma Diallo, MD

    Institut de Recherche pour le Developpement

    PRINCIPAL INVESTIGATOR

  • John C Victor, PhD, MPH

    PATH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

March 27, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 22, 2013

Record last verified: 2013-06

Locations

SE(1)