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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00649883
First received: March 25, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Influenza Trivalent Inactivated vaccines Novartis
Biological: Influenza Trivalent Inactivated vaccines
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. [ Time Frame: 211 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 211 days ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: January 2008
Study Completion Date: October 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Active Comparator: 2 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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649883

Locations
Guatemala
Hospital Infantil de Infectologia y rehabilitacion
Guatemala City, Guatemala
Dr. Carlos Fernando Grazioso Aragón
Guatemala City, Guatemala
Clínicas Dr. Rafael Montiel
Guatemala City, Guatemala
Fundación Pediátrica Guatemalteca
Guatemala City, Guatemala
Centro Clínico La Quinta
Guatemala City, Guatemala
Sponsors and Collaborators
Novartis
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00649883     History of Changes
Other Study ID Numbers: V70P6
Study First Received: March 25, 2008
Last Updated: December 7, 2011
Health Authority: Guatemala: Ministero de Salud publica, Comission para la evaluacion de ensavos clinicos

Keywords provided by Novartis:
Influenza
vaccine
children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014