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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649883
• Other study ID #: V70P6
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2008
• Last updated: April 5, 2017
• Start date: January 2008
• Est. completion date: October 2008

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
Guatemala	Centro Clínico La Quinta	Guatemala City
Guatemala	Clínicas Dr. Rafael Montiel	Guatemala City
Guatemala	Dr. Carlos Fernando Grazioso Aragón	Guatemala City
Guatemala	Fundación Pediátrica Guatemalteca	Guatemala City
Guatemala	Hospital Infantil de Infectologia y rehabilitacion	Guatemala City

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		211 days
Secondary	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.		211 days

External Links

•   Link for study results for V70P6 from Novartis Clinical Trials website