Inactivated Influenza Vaccine Effectiveness in Tropical Africa

NCT00893906 | Completed Phase 4

• 1 other identifier: TIV-SEN-01
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its disease burden is seriously lacking. Such data would be important in determining the contribution of influenza to the more than two million annual pneumonia deaths among children globally, mostly in the developing world, and the potential number of deaths that could be prevented by influenza vaccination. A single dose of trivalent inactivated influenza vaccine (TIV) is 70 to 90 percent effective in preventing influenza in healthy older children and young and middle-aged adults, but is less efficacious in young children and the elderly. Young children who suffer substantial influenza morbidity and are unlikely to have pre-existing immunity should receive two doses of TIV to provide adequate immunity. Because family studies of influenza transmission conducted during the 1970's found children to be the main introducers of influenza into households, vaccination of children may decrease the chances of spreading influenza to contacts. Mass vaccination of schoolchildren has been correlated with reduced respiratory illness in unvaccinated persons suggesting that immunization of children on a larger scale can affect community epidemics. In temperate industrialized countries with seasonal disease, influenza vaccine is given annually, prior to the influenza season, and generally targeted to individuals with the highest risk of severe disease. Influenza prevention strategies may need to differ in tropical developing countries due to a variety of reasons. Given the varying influenza circulation patterns, it is unknown which hemisphere vaccine formulation will provide year-round protection against the diverse strains that may exist in tropical countries. Persons residing in developing countries also may have nutritional deficiencies or underlying diseases and infections that affect vaccine immunogenicity. Consideration must be given to programmatic issues as well. Adolescent and adult preventive health services are poorly developed in many countries, and thus a strategy that targets children may be the most feasible option. In addition, vaccinating children may be the most cost-effective option, as it has the potential to provide direct benefit to those vaccinated, as well as indirect benefits to unvaccinated members of the population. Thus, an influenza vaccine effectiveness study in a tropical developing country population will help to elucidate burden of seasonal influenza and may inform optimal use of vaccine for either seasonal and pandemic situations. Thus, this study in Senegal will to evaluate the direct effects of TIV in reducing the occurrence of laboratory-confirmed influenza among children who receive it as well as the potential indirect effects experienced by the population as a result of reducing transmission among children.

Conditions

Influenza

Keywords

influenza; influenza vaccine; vaccine effectiveness; cluster randomized; Africa

Outcome Measures

Primary Outcomes (1)

• Total effectiveness of vaccine against laboratory-confirmed symptomatic influenza.

  Two weeks post-vaccination through February 28 the following calendar year

Secondary Outcomes (3)

• Indirect effectiveness against laboratory-confirmed symptomatic influenza

  Two weeks post-vaccination through February 28 the following calendar year

• Overall effectiveness of vaccine against laboratory-confirmed symptomatic influenza

  Two weeks post-vaccination through February 28 the following calendar year

• Direct effectiveness of vaccine against laboratory-confirmed symptomatic influenza

  Two weeks post-vaccination through February 28 the following calendar year

Study Arms (2)

TIV

EXPERIMENTAL

Children living in villages randomized to influenza vaccine

Biological: seasonal trivalent inactivated influenza vaccine

IPV

EXPERIMENTAL

Children living in villages randomized to polio vaccine

Biological: inactivated polio vaccine

Interventions

seasonal trivalent inactivated influenza vaccine BIOLOGICAL

vaccine to be used according to marketed dosage and frequency

Also known as: Vaxigrip

TIV

inactivated polio vaccine BIOLOGICAL

vaccine to be used according to marketed dosage and frequency

Also known as: Imovax Polio

IPV

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A male or female child at least 6 months of age and no older than 10 years of age (has not yet reached 11 years of age) at the enrollment visit.
• A child whose parent or guardian's primary residence, at the time of study vaccinations, is a village compound selected to receive TIV or IPV.
• 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:

• Hypersensitivity to the active substance or any component in either TIV (which includes egg protein) or IPV. (Please see information on composition of vaccines.)
• Hypersensitivity after previous administration of any influenza or polio vaccine.
• Any condition that, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• PATH: lead
• Institut de Recherche pour le Developpement: collaborator
• Institut Pasteur: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Niakhar Demographic Surveillance System

Niakhar, Fatick District, Senegal

Location

Related Publications (2)

• Niang MN, Sugimoto JD, Diallo A, Diarra B, Ortiz JR, Lewis KDC, Lafond KE, Halloran ME, Widdowson MA, Neuzil KM, Victor JC. Estimates of Inactivated Influenza Vaccine Effectiveness Among Children in Senegal: Results From 2 Consecutive Cluster-Randomized Controlled Trials in 2010 and 2011. Clin Infect Dis. 2021 Jun 15;72(12):e959-e969. doi: 10.1093/cid/ciaa1689.

  PMID: 33165566 DERIVED

• Diallo A, Diop OM, Diop D, Niang MN, Sugimoto JD, Ortiz JR, Faye EHA, Diarra B, Goudiaby D, Lewis KDC, Emery SL, Zangeneh SZ, Lafond KE, Sokhna C, Halloran ME, Widdowson MA, Neuzil KM, Victor JC. Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial. Clin Infect Dis. 2019 Oct 30;69(10):1780-1788. doi: 10.1093/cid/ciz066.

  PMID: 30689757 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip; Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• John C Victor, PhD, MPH

  PATH

  STUDY DIRECTOR

• Aldiouma Diallo, MD

  IRD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

SE (1)