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

Influenza Clinical Trial

Official title:

Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819155
• Other study ID #: MF59-TIV-SEN-01
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2013
• Last updated: October 18, 2013
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministre de la Santé et de l'Action Sociale
• Study type: Interventional

Clinical Trial 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.

Description:

The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months through 71 months in the town of Niakhar, Senegal. A total of 300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo. Each child will receive two doses of one of the three study vaccines, with each dose given 28 days apart. Each child will be followed closely for safety after each dose for the period from one month post-dose two to 3 months post-dose two. For determination of immune response to vaccination or background influenza infection, 3 mL of blood will be obtained at three time points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days post-dose two. Serum anti-influenza antibodies produced against virus strains contained in the vaccine will be detected using hemagglutination inhibition assay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 71 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of <37.5°C, are not reason for exclusion or postponing study vaccination.)

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Adjuvanted seasonal trivalent inactivated influenza vaccine

• Seasonal trivalent inactivated influenza vaccine

• Saline (bacteriostatic 0.9% sodium chloride for injection)

Locations

Country	Name	City	State
Senegal	Institut de Recherche pour le Développement	Niakhar

Sponsors (3)

Lead Sponsor	Collaborator
PATH	Centers for Disease Control and Prevention, Institut de Recherche pour le Developpement

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of adjTIV	serum hemagglutination-inhibition antibodies	28 days post-dose 2	No
Primary	Immunogenicity of TIV	serum hemagglutination-inhibition antibodies	28 days post-dose 2	No
Secondary	Adverse events		through three months post-dose 2	Yes