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

NCT ID: NCT00649883

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-10-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: EXPERIMENTAL

Influenza Trivalent Inactivated vaccines Novartis

Intervention Type: BIOLOGICAL

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

2

Group Type: ACTIVE_COMPARATOR

Influenza Trivalent Inactivated vaccines

Intervention Type: BIOLOGICAL

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Interventions

Influenza Trivalent Inactivated vaccines Novartis

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Intervention Type: BIOLOGICAL

Influenza Trivalent Inactivated vaccines

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Clínico La Quinta

Guatemala City, Guatemala City, Guatemala

Clínicas Dr. Rafael Montiel

Guatemala City, Guatemala City, Guatemala

Dr. Carlos Fernando Grazioso Aragón

Guatemala City, Guatemala City, Guatemala

Fundación Pediátrica Guatemalteca

Guatemala City, Guatemala City, Guatemala

Hospital Infantil de Infectologia y rehabilitacion

Guatemala City, Guatemala City, Guatemala

Countries

Guatemala

Other Identifiers

V70P6

Identifier Type: -

Identifier Source: org_study_id