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Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

PHRR130221-000052

Protocol No. V70_29

Unspecified

A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age

This Study Will Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age.

Start Date Duration in Months Target Completion Date Actual Completion Date
2011-04-09 15 2012-07-09 0000-00-00

Completed

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR
Institution Amount Region
Novartis Healthcare Philippines, Inc. N/A NCR
Name E-Mail Phone Number Postal Address
Leilani Sanchez leilani_lee.sanchez@novartis.com +632 368 7777 Novartis Healthcare Philippines, Inc. 5F Republic Glass Building, 196 Salcedo St. Legaspi Village, Makati City, Philippines
Name E-Mail Phone Number Postal Address
Sanjay Patel sanjay.patel@novartis.com +1 6178718000 Novartis Vaccines and Diagnostics, Inc., Cambridge Site, 250 Massachusetts Avenue, Cambridge, MA 02139, USA
Name Expertise Affiliation
Jo-Anne A. de Castro, MD Pediatrician De La Salle Health Sciences Institute
Mary Ann Corrales-Bunyi, MD Pediatrician Philippine Children's Medical Center
Sandra Litao, MD Pediatrician De La Salle Health Sciences Institute
Jaime A. Santos, MD Pediatrician Philippine Children's Medical Center
Arnel Gerald Jiao, MD Pediatrician Philippine Children's Medical Center
Ma. Liza Antoinette M. Gonzales, MD Pediatrician Philippine General Hospital
Lulu C. Bravo, MD Pediatric, Infectious Diseases Philippine General Hospital
Beatriz P. Quiambao, MD Pediatrician Research Institute for Tropical Medicine
Charissa Fay C. Borja-Tabora, MD Pediatrician Research Institute for Tropical Medicine
Josefina B. Cadorna-Carlos, MD Pediatrician University of the East Ramon Magsaysay Memorial Medical Center
Delia Caparas-Yu, MD Pediatrician De La Salle Health Sciences Institute
May Book-Montellano, MD Pediatrician Mary Chiles General Hospital
Anna Lisa Ong-Lim, MD Pediatrician Philippine General Hospital
Benjamin P. Sablan, Jr., MD Pediatric Philippine General Hospital
Project Location Institutional Ethics Review Board
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board
University of the East Ramon Magsaysay Memorial Medical Center N/A
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee
Mary Chiles General Hospital Mary Chiles General Hospital Ethics Review Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board

Influenza Disease

[1] Serious adverse events and other significant medical occurrences from Day 1 through Day 394; [ Time Frame: 394 days ] [ Designated as safety issue: Yes ] [2] Solicited local and systemic reaction 7 days following each vaccination; [3] All unsolicited adverse events from Day 1 to Day 50; [4] Immunogenicity assessments at Day 29, Day 50, and Day 209.

Immunogenicity assessments comparing at-risk vs non-at-risk subjects, naive vs. non-naive subjects, and in specific age cohorts. [ Time Frame: Immunogenicity assesments will be measured at Day 29, 50, and 209. ] [ Designated as safety issue: No ]

Completed

  • Argentina
  • Australia
  • Chile
  • Philippines
  • South Africa

Clinical Trial

Unspecified

Unspecified

None

Inclusion Criteria: 1.Children 6 months to 72 months of age Exclusion Criteria: 1. Children that are hospitalized at the time of enrollment 2. Any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein 3. Children with known impairment of the immune function 4. Children with a fever interfering with normal daily activities at the time of enrollment 5. Children that have received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study 6. Concomitant participation in another clinical study 7. Surgery planned during the study period that in the investigator's opinion would interfere with the study visits schedule

Interventional

(1) Biological: eTIV_a surface antigen, inactivated, non-adjuvanted with MF-59 Other Name: eTIV_a for Agriflu vaccine (2) Biological: MF59-eTIV surface antigen, inactivated, adjuvanted with MF-59 Other Name: MF59-eTIV for Fluad (3) Biological: eTIV_split

(1) Active Comparator: Adjuvanted Trivalent Subunit Influenza Vaccine Intervention: Biological: MF59-eTIV (2) Active Comparator: Non-adjuvanted Trivalent Subunit Influenza Vaccine Intervention: Biological: eTIV_a (3) Active Comparator: Non-adjuvanted Trivalent Split Influenza Vaccine Intervention: Biological: eTIV_split

Randomized

Observer-blind

Unspecified

Parallel

Prevention

Phase III

3500

4514

Target sample sizes are just approximate values.

09 Apr 2011

Utilization Utilization Info
Publication *Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

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