A Phase 1/2 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years

Resilience Government Services, Inc.20 sites in 4 countries684 target enrollmentDecember 2009

ConditionsInfluenza, Avian

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza, Avian
Sponsor: Resilience Government Services, Inc.
Enrollment: 684
Locations: 20
Primary Endpoint: Frequency and severity of systemic reactions until 7 days after the first vaccination
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Resilience Government Services, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•9 to 17 years of age on the day of screening (for Stratum A only)
•3 to 8 years of age on the day of screening (for Stratum B only)
•6 to 35 months of age on the day of screening (for Stratum C only)
•Subject who were born at full term of pregnancy (\>= 37 weeks) with a birth weight \>= 2 kg (for Stratum C only)
•Subjects and/or their parents/legal guardians understand the nature and procedures of the study and agree to its provisions
•Subjects´ parents/legal guardians provide written consent for participation according to national law. In case the parents/legal guardians are illiterate, the informed consent is also to be signed by an independent witness
•Written assent according to subjects´ age and capacity of understanding
•Subjects who are generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination
•Subjects who are physically and mentally capable of participating in the study and follow its procedures
•Subjects and/or their parents/legal guardians agree to keep a daily record of symptoms for the duration of the study

Exclusion Criteria

•History of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
•High risk of contracting H5N1 influenza infection (e.g. contact with poultry);
•Subjects who currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
•Inherited or acquired immunodeficiency
•Subjects who have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
•History of severe allergic reactions or anaphylaxis
•Rash, dermatological condition or tattoos which may interfere with injection site reaction rating
•Subjects who have received a blood transfusion or immunoglobulins within 90 days prior to study entry
•Subjects who have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
•Functional or surgical asplenia

Outcomes

Primary Outcomes

Frequency and severity of systemic reactions until 7 days after the first vaccination

Time Frame: 7 days

Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization test >= 1:20.

Time Frame: 42 days

Secondary Outcomes

Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination(Day 21, 42 and 381)
Fever, malaise or shivering (in children and adolescents aged 3 to 17 years) and fever and irritability (in infants and young children aged 6 to 35 months) with onset within 7 days after the first, second and booster vaccination(Day 21, 42 and 381)
Adverse events observed during the entire study period(Throughout entire study period)
Antibody response associated with protection 21 days after the first and second vaccination, and again at 360 days after the first vaccination and 21 days after the booster vaccination(Day 21, 42, 360 and 381)
Fold increase of antibody response 21 days after first and second vaccination as compared to baseline, and again at 21 days after the booster vaccination as compared to before the booster vaccination(Day 21, 42, 360 and 381)
Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination(Day 21, 42 and 381)