Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00836953|
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : August 27, 2009
Last Update Posted : April 14, 2016
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.
To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Influenza virus vaccine (Pediatric formulation)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||July 2004|
Experimental: Study Group
Participants received 2 doses of Fluzone® vaccine
Biological: Influenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Other Name: Fluzone®
- Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-vaccination ]Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
- Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) [ Time Frame: Day 0 and Day 14 after Dose 2 ]Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.
- Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) [ Time Frame: Day 0 and Day 14 Post-dose 2 ]Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836953
|United States, Virginia|
|Norfolk, Virginia, United States, 23510|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|