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:
Novartis
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
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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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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
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 June 17, 2013