Clinical trial NCT00649883: Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months
Official title: A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
vaccine
children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2008-04-01
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.


Eligibility criteria: Inclusion Criteria:

* Children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
* In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
* Able to comply with all study procedure

Exclusion Criteria:

* Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
* History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
* Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
* Bleeding diathesis;
* Surgery planned during the study period;
* Receipt of another investigational agent within 90 days
* Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
* Ever received two doses of an influenza vaccine before the study
* Receipt of an influenza vaccine within 6 months prior to Visit 1;
* Experienced a temperature 38.0°C within 3 days prior to Visit 1

Primary outcomes:
measure: To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.
timeFrame: 211 days
Secondary outcomes:
measure: To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.
timeFrame: 211 days
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Centro Clínico La Quinta
city: Guatemala City
country: Guatemala
facility: Clínicas Dr. Rafael Montiel
city: Guatemala City
country: Guatemala
facility: Dr. Carlos Fernando Grazioso Aragón
city: Guatemala City
country: Guatemala
facility: Fundación Pediátrica Guatemalteca
city: Guatemala City
country: Guatemala
facility: Hospital Infantil de Infectologia y rehabilitacion
Study officials:
References: