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 Region
Novartis Healthcare Philippines, Inc. 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
Anna Lisa Ong-Lim, MD Pediatrician Philippine General Hospital
Arnel Gerald Jiao, MD Pediatrician Philippine Children's Medical Center
Beatriz P. Quiambao, MD Pediatrician Research Institute for Tropical Medicine
Benjamin P. Sablan, Jr., MD Pediatric Philippine General Hospital
Charissa Fay C. Borja-Tabora, MD Pediatrician Research Institute for Tropical Medicine
Delia Caparas-Yu, MD Pediatrician De La Salle Health Sciences Institute
Jaime A. Santos, MD Pediatrician Philippine Children's Medical Center
Jo-Anne A. de Castro, MD Pediatrician De La Salle Health Sciences Institute
Josefina B. Cadorna-Carlos, MD Pediatrician University of the East Ramon Magsaysay Memorial Medical Center
Lulu C. Bravo, MD Pediatric, Infectious Diseases Philippine General Hospital
Ma. Liza Antoinette M. Gonzales, MD Pediatrician Philippine General Hospital
Mary Ann Corrales-Bunyi, MD Pediatrician Philippine Children's Medical Center
May Book-Montellano, MD Pediatrician Mary Chiles General Hospital
Sandra Litao, MD Pediatrician De La Salle Health Sciences Institute
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Philippine General Hospital Taft Avenue, 1000, Manila Anna Lisa Ong-Lim, MD Pediatrician
Philippine Children's Medical Center Agham Road, 1104, Quezon City Arnel Gerald Jiao, MD Pediatrician
Research Institute for Tropical Medicine Department of Health Compound, FILINVEST Corporate City, Alabang, 1781, Muntinlupa Beatriz P. Quiambao, MD Pediatrician
Philippine General Hospital Philippine General Hospital Benjamin P. Sablan, Jr., MD Pediatric
Research Institute for Tropical Medicine Department of Health Compound, FILINVEST Corporate City, Alabang, 1781, Muntinlupa Charissa Fay C. Borja-Tabora, MD Pediatrician
De La Salle Health Sciences Institute Congressional Ave., Dasmarinas, 4114, Cavite Delia Caparas-Yu, MD Pediatrician
Philippine Children's Medical Center Quezon Avenue, cor. Agham Road, 1104, Quezon City Jaime A. Santos, MD Pediatrician
De La Salle Health Sciences Institute Congressional Ave., Dasmarinas, 4114, Cavite Jo-Anne A. de Castro, MD Pediatrician
University of the East Ramon Magsaysay Memorial Medical Center 64 Aurora Boulevard, Barangay Doria Imelda, 1113, Quezon City Josefina B. Cadorna-Carlos, MD Pediatrician
Philippine General Hospital Philippine General Hospital Lulu C. Bravo, MD Pediatric, Infectious Diseases
Philippine General Hospital Taft Avenue, 1000, Manila Ma. Liza Antoinette M. Gonzales, MD Pediatrician
Philippine Children's Medical Center Quezon Avenue, cor. Agham Road, 1104, Quezon City Mary Ann Corrales-Bunyi, MD Pediatrician
Mary Chiles General Hospital 667 Gastambide St. Sampaloc, 1008, Manila May Book-Montellano, MD Pediatrician
De La Salle Health Sciences Institute Dasmarinas, 4114, Cavite Sandra Litao, MD Pediatrician
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional 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
University of the East Ramon Magsaysay Memorial Medical Center N/A
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee
Mary Chiles General Hospital Mary Chiles General Hospital Ethics Review Committee
De La Salle Health Sciences Institute De La Salle Health Sciences Institute Independent Ethics Committee

Clinical Trial

Unspecified

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

Protocol No. V70_29

Unspecified

Unspecified

0000-00-00

Protocol Code Number Protocol No. V70_29
Protocol Version Unspecified
Date of Protocol Version Unspecified

3500

4514

Target sample sizes are just approximate values.

Unspecified

09 Apr 2011

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

None

Method of Allocation

Randomized

Masking or Blinding

Observer-blind

Masking Details

Unspecified

Control

Unspecified

Assignment

Parallel

Phase

Phase III

Purpose of the Study

Prevention

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

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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