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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

NCT00649883 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-04-07

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-04-30
Completion
2008-10-31

Countries

  • Guatemala

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00649883 on ClinicalTrials.gov