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Trial record 1 of 1 for:    GRC21
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Study of Safety and Immunogenicity of Fluzone® in Healthy Children

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ClinicalTrials.gov Identifier: NCT00831675
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : August 27, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
Enrollment 30
Recruitment Details The study participants took part in the study from 16 September through 18 November 2004 in 1 US site.
Pre-assignment Details A total of 30 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Infants <12 Months Toddlers ≥12 Months
Hide Arm/Group Description Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively. Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Period Title: Overall Study
Started 12 18
Completed 12 18
Not Completed 0 0
Arm/Group Title Infants <12 Months Toddlers ≥12 Months Total
Hide Arm/Group Description Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively. Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively. Total of all reporting groups
Overall Number of Baseline Participants 12 18 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 30 participants
<=18 years
12
 100.0%
18
 100.0%
30
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Age Continuous Number Analyzed 12 participants 18 participants 30 participants
8.9  (2.1) 20  (6.0) 15.6  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 30 participants
Female
4
  33.3%
9
  50.0%
13
  43.3%
Male
8
  66.7%
9
  50.0%
17
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 18 participants 30 participants
12 18 30
1.Primary Outcome
Title Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
Hide Description

Solicited local reactions: Erythema, bruising, induration, pain at injection site.

Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.

Time Frame Days 0-3 Post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population
Arm/Group Title Infants <12 Months Toddlers ≥12 Months
Hide Arm/Group Description:
Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Overall Number of Participants Analyzed 12 18
Measure Type: Number
Unit of Measure: Participants
Any Solicited Local Reaction Post-dose 1 3 7
Any Erythema (>0.5 cm) 0 2
Grade 3 Erythema (>5.0 cm) 0 0
Any Induration (>0.5 cm) 0 0
Grade 3 Induration (>5.0 cm) 0 0
Any Bruising (>0.5 cm) 0 0
Grade 3 Bruising (>5.0 cm) 0 0
Any Pain 3 5
Grade 3 Pain (Cry When inj. Limb is Moved) 0 0
Any Solicited Local Reaction Post-dose 2 4 4
Any Erythema (> 0.5 cm) 2 0
Grade 3 Erythema (>5.0 cm) 0 0
Any Induration (>0.5 cm) 0 0
Grade 3 Induration (>5.0 cm) 0 0
Any Bruising (>0.5 cm) 2 0
Grade 3 Bruising (>5.0 cm) 0 0
Any Pain 4 4
Grade 3 Pain (Cry When inj. Limb Is Moved) 0 0
Any Solicited Systemic Reaction Post-dose 1 7 12
Any Fever 0 3
Grade 3 Fever (>103.1 ºF) 0 0
Any Irritability 5 9
Grade 3 Irritability (>3 hours) 0 1
Any Crying 3 6
Grade 3 Crying (>3 hours) 0 0
Any Lethargy 1 1
Grade 3 Lethargy (Disabling) 0 0
Any Appetite Decreased 1 4
Grade 3 Appetite Decreased (refuses over 3 feeds) 0 0
Any Vomiting 1 1
Grade 3 Vomiting (3 or more episodes) 0 1
Any Diarrhea 3 1
Grade 3 Diarrhea (>5 Diarrhea Stools) 0 0
Rash - Presence of Welts 1 1
Any Solicited Systemic Reaction Post-dose 2 6 10
Any Fever 1 3
Grade 3 Fever (>103.1 ºF) 0 0
Any Irritability 5 6
Grade 3 Irritability (>3 hours) 1 0
Any Crying 4 3
Grade 3 Crying (>3 hours) 0 0
Any Lethargy 1 1
Grade 3 Lethargy (Disabling) 0 0
Any Appetite Decreased 3 6
Grade 3 Appetite Decreased (refuses 3 feeds) 0 0
Any Vomiting 1 2
Grade 3 Vomiting (3 or more episodes) 0 0
Any Diarrhea 3 0
Grade 3 Diarrhea (>5 Diarrhea Stools) 0 0
Rash - Presence of Welts 1 0
2.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation
Hide Description [Not Specified]
Time Frame 14 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were evaluated in the per-protocol population
Arm/Group Title Infants <12 Months Toddlers ≥12 Months
Hide Arm/Group Description:
Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Overall Number of Participants Analyzed 12 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/New Caledonia/20/99, Pre-dose
7.9
(6.4 to 9.9)
9.4
(7.0 to 12.8)
A/New Caledonia/20/99, Post-dose
15.0
(11.2 to 20.1)
26.2
(15.8 to 43.3)
A/Wyoming/03/2003, Pre-dose
7.9
(4.8 to 13.2)
14.4
(6.5 to 31.8)
A/Wyoming/03/2003, Post-dose
31.7
(12.9 to 78.2)
108.9
(44.8 to 264.7)
B/Jiangsu/10/2003, Pre-dose
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
B/Jiangsu/10/2003, Post-dose
7.5
(5.0 to 11.1)
8.4
(6.5 to 10.8)
3.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
Hide Description Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.
Time Frame 14 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection were evaluated in the per-protocol population
Arm/Group Title Infants <12 Months Toddlers ≥12 Months
Hide Arm/Group Description:
Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Overall Number of Participants Analyzed 12 18
Measure Type: Number
Unit of Measure: Percentage of Participants
A/New Caledonia/20/99 8 39
A/Wyoming/03/2003 50 67
B/Jiangsu/10/2003 8 0
4.Other Pre-specified Outcome
Title Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)
Hide Description Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.
Time Frame Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion were evaluated in the per-protocol population.
Arm/Group Title Infants <12 Months Toddlers ≥12 Months
Hide Arm/Group Description:
Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
Overall Number of Participants Analyzed 12 18
Measure Type: Number
Unit of Measure: Percentage of Participants
A/New Caledonia/20/99 33 50
A/Wyoming/03/2003 58 100
B/Jiangsu/10/2003 8 17
Time Frame Adverse event data were collected from the day of vaccination to Day 42 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infants <12 Months Toddlers ≥12 Months
Hide Arm/Group Description Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively. Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
All-Cause Mortality
Infants <12 Months Toddlers ≥12 Months
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infants <12 Months Toddlers ≥12 Months
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infants <12 Months Toddlers ≥12 Months
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      14/18 (77.78%)    
Eye disorders     
Conjunctivitis * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders     
Diarrhoea NOS * 1  2/12 (16.67%)  2 0/18 (0.00%)  0
Gingival swelling * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Teething * 1  7/12 (58.33%)  9 3/18 (16.67%)  3
Vomiting NOS * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
General disorders     
Pyrexia * 1  4/12 (33.33%)  4 4/18 (22.22%)  4
Infections and infestations     
Bronchiolitis * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Coxsackie viral infection * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Gastroenteritis NOS * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
Hand-foot-and-mouth disease * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Nasopharyngitis * 1  1/12 (8.33%)  1 3/18 (16.67%)  3
Oral candidiasis * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
Otitis media NOS * 1  3/12 (25.00%)  3 3/18 (16.67%)  3
Pharyngitis * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Pharyngitis streptococcal * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Pneumonia NOS * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Rhinitis infective * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
Sinusitis NOS * 1  2/12 (16.67%)  2 1/18 (5.56%)  1
Upper respiratory tract infection NOS * 1  5/12 (41.67%)  5 2/18 (11.11%)  2
Upper respiratory tract infection viral NOS * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Injury, poisoning and procedural complications     
Arthropod bite * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Thermal burn * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Investigations     
Body temperature increased * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
Psychiatric disorders     
Irritability * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma NOS * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Cough * 1  4/12 (33.33%)  4 3/18 (16.67%)  4
Nasal congestion * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
Rhinorrhoea * 1  3/12 (25.00%)  3 2/18 (11.11%)  4
Dermatitis NOS * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders     
Rash NOS * 1  1/12 (8.33%)  1 0/18 (0.00%)  0
Urticaria NOS * 1  0/12 (0.00%)  0 1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00831675     History of Changes
Other Study ID Numbers: GRC21
First Submitted: January 28, 2009
First Posted: January 29, 2009
Results First Submitted: July 20, 2009
Results First Posted: August 27, 2009
Last Update Posted: April 14, 2016