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CompletedNCT00391391Updated Dec 1, 2011Results posted

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

A Phase 2 interventional study of Split, Inactivated, Trivalent Influenza Vaccine and Split, Inactivated, Trivalent Influenza Vaccine in Orthomyxoviridae Infection, Influenza and Myxovirus Infection, sponsored by Sanofi. Completed at 19 sites in United States. Open to participants aged 6 Months to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-01.

Sponsored by Sanofi · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
6 Months to 8 Years
Sex
All
01

Study summary

Primary Objective:

To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Secondary Objectives:

  • To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
  • To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
02

Conditions studied

  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection

Keywords

  • Influenza
  • Orthomyxoviruses
  • Inactivated Split-virion influenza vaccine
  • Infants
  • children.
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 520 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
  • Subject is healthy, as determined by medical history.
  • Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
  • Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

Exclusion criteria

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Personal or family history of Guillain-Barré Syndrome.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Received blood or blood-derived products in the previous 3 months.
  • Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
  • Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
  • Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
  • History of seizures.
  • Received antibiotics therapy within 72 hours preceding the trial vaccination.
  • Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
  • Any condition, which in the opinion of the investigator would pose a health risk to the participant.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
520 participants (actual)

Study arms

  • Experimental
    1

    Split, Inactivated, Trivalent Influenza Vaccine

    Biological: Split, Inactivated, Trivalent Influenza Vaccine

  • Experimental
    2

    Split, Inactivated, Trivalent Influenza Vaccine

    Biological: Split, Inactivated, Trivalent Influenza Vaccine

  • Active comparator
    3

    Split, Inactivated, Trivalent Influenza Vaccine

    Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

  • Active comparator
    4

    Split, Inactivated, Trivalent Influenza Vaccine

    Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Interventions

  • BiologicalSplit, Inactivated, Trivalent Influenza Vaccine

    Vaccine (infant dose)

  • BiologicalSplit, Inactivated, Trivalent Influenza Vaccine

    Vaccine (children dose)

  • BiologicalSplit, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

    Vaccine (infant dose)

    Also known as: Fluzone® 2006/2007 Formulation.

  • BiologicalSplit, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

    Vaccine (children dose)

    Also known as: Fluzone® 2006/2007 Formulation.

06

What researchers measure

Primary outcomes

  1. Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

    Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

    Time frame: Day 0 and Day 28 post-vaccination

Secondary outcomes

  1. Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

    Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

    Time frame: Day 28 post-vaccination

  2. Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

    Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

    Time frame: Day 28 post-vaccination

  3. Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

    Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.

    Time frame: Day 28 post-vaccination

  4. Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.

    Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.

    Time frame: Day 0 to Day 7 post-vaccination

  5. Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds

    Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.

    Time frame: Day 0 to Day 7 post-vaccination

07

Results

Posted Nov 22, 2011

Participant flow

Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.

Participant flow — Overall Study
MilestoneGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Started9897161164
Completed8987138145
Not completed9102319
Withdrew: Adverse event0001
Withdrew: Lost to follow-up1374
Withdrew: Protocol violation2367
Withdrew: Withdrawal by subject64107

Outcome measures

PrimaryGeometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time frame:
Day 0 and Day 28 post-vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
TitersGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Serogroup A/H1N1 Pre-vaccination8.9 (7.1 to 11.2)9.6 (7.5 to 12.3)20.5 (15.6 to 26.9)26.9 (19.6 to 37.1)
Serogroup A/H1N1 Post-vaccination 158.5 (28.6 to 119.4)113.1 (59.9 to 213.7)100.1 (55.0 to 182.1)264.2 (162.8 to 428.9)
Serogroup A/H1N1 Post-vaccination 2138.3 (105.2 to 181.8)160.0 (123.7 to 206.9)162.9 (128.7 to 206.3)390.6 (308.2 to 495.0)
Serogroup A/H3N2 Pre-vaccination22.4 (14.0 to 35.9)20.9 (13.7 to 31.9)222.2 (165.4 to 298.5)171.0 (121.5 to 240.7)
Serogroup A/H3N2 Post-vaccination 1341.8 (142.9 to 817.7)566.9 (304.6 to 1054.9)1012.5 (666.9 to 1537.2)1256.9 (898.2 to 1758.8)
Serogroup A/H3N2 Post-vaccination 2614.8 (471.3 to 802.0)471.4 (368.0 to 603.7)1111.0 (944.0 to 1307.5)1344.4 (1146.1 to 1577.1)
Serogroup B Pre-vaccination5.3 (4.9 to 5.8)5.4 (5.0 to 5.9)8.3 (7.1 to 9.7)6.8 (6.0 to 7.7)
Serogroup B Post-vaccination 17.4 (4.4 to 12.5)9.7 (4.2 to 22.1)46.6 (23.3 to 93.3)28.8 (16.0 to 52.0)
Serogroup B Post-vaccination 231.1 (23.7 to 40.8)18.2 (13.9 to 24.0)56.4 (43.8 to 72.7)51.6 (40.8 to 65.2)
SecondaryPercentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time frame:
Day 28 post-vaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Percentage of ParticipantsGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Serogroup A/H1N1 Post-vaccination 15275 (0 to 0)65 (0 to 0)74 (0 to 0)
Serogroup A/H1N1 Post-vaccination 29188 (0 to 0)70 (0 to 0)78 (0 to 0)
Serogroup A/H3N2 Post-vaccination 18180 (0 to 0)44 (0 to 0)63 (0 to 0)
Serogroup A/H3N2 Post-vaccination 28891 (0 to 0)50 (0 to 0)62 (0 to 0)
Serogroup B Post-vaccination 1510 (0 to 0)44 (0 to 0)40 (0 to 0)
Serogroup B Post-vaccination 24421 (0 to 0)55 (0 to 0)53 (0 to 0)
SecondaryPercentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time frame:
Day 28 post-vaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Percentage of ParticipantsGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Serogroup A/H1N1 Pre-vaccination912 (0 to 0)33 (0 to 0)40 (0 to 0)
Serogroup A/H1N1 Post-vaccination 15275 (0 to 0)79 (0 to 0)95 (0 to 0)
Serogroup A/H1N1 Post-vaccination 29193 (0 to 0)92 (0 to 0)99 (0 to 0)
Serogroup A/H3N2 Pre-vaccination3229 (0 to 0)86 (0 to 0)80 (0 to 0)
Serogroup A/H3N2 Post-vaccination 18595 (0 to 0)97 (0 to 0)100 (0 to 0)
Serogroup A/H3N2 Post-vaccination 2100100 (0 to 0)99 (0 to 0)100 (0 to 0)
Serogroup B Pre-vaccination22 (0 to 0)9 (0 to 0)3 (0 to 0)
Serogroup B Post-vaccination 1510 (0 to 0)47 (0 to 0)42 (0 to 0)
Serogroup B Post-vaccination 24421 (0 to 0)63 (0 to 0)58 (0 to 0)
SecondaryPercentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.

Time frame:
Day 28 post-vaccination
Reported as:
Number · Percentage of Participants
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Percentage of ParticipantsGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Serogroup A/H1N1 Post-vaccination 15275 (0 to 0)65 (0 to 0)74 (0 to 0)
Serogroup A/H1N1 Post-vaccination 29188 (0 to 0)70 (0 to 0)78 (0 to 0)
Serogroup A/H3N2 Post-vaccination 18180 (0 to 0)44 (0 to 0)63 (0 to 0)
Serogroup A/H3N2 Post-vaccination 28891 (0 to 0)50 (0 to 0)62 (0 to 0)
Serogroup B Post-vaccination 1510 (0 to 0)44 (0 to 0)40 (0 to 0)
Serogroup B Post-vaccination 24421 (0 to 0)55 (0 to 0)53 (0 to 0)
SecondaryNumber of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.

Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.

Time frame:
Day 0 to Day 7 post-vaccination
Reported as:
Number · Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
ParticipantsGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Any injection site tenderness Injection 15143——
Grade 3 Tenderness (Reduced movement)00——
Any Injection site redness Injection 14827——
Grade 3 redness ( ≥ 5 cm)00——
Any Injection site swelling Injection 12315——
Grade 3 swelling ( ≥ 5 cm)00——
Any Injection site induration Injection 12413——
Grade 3 induration ( ≥ 5 cm)00——
Any Injection site ecchymosis Injection 11213——
Grade 3 ecchymosis ( ≥ 5 cm)10——
Any injection site tenderness Injection 24849——
Grade 3 Tenderness (Reduced movement)11——
Any Injection site redness Injection 24828——
Grade 3 redness ( ≥ 5 cm)10——
Any Injection site swelling Injection 21813——
Grade 3 swelling ( ≥ 5 cm)10——
Any Injection site induration Injection 21814——
Grade 3 induration ( ≥ 5 cm)00——
Any Injection site ecchymosis Injection 22313——
Grade 3 ecchymosis ( ≥ 5 cm)10——
Any Solicited Fever Injection 11010——
Grade 3 Fever > 103.1°F10——
Any Solicited Vomiting Injection 156——
Grade 3 Vomiting ≥ 6 episodes per 24 hours00——
Any Solicited Crying Abnormal Injection 11729——
Grade 3 Crying Abnormal >3 hours30——
Any Solicited Drowsiness Injection 12124——
Grade 3 Drowsiness Sleeping most of the time30——
Any Solicited Appetite Lost Injection 12021——
Grade 3 Appetite Lost refuses most feeds30——
Any Solicited Irritability Injection 13739——
Grade 3 Irritability inconsolable21——
Any Solicited Fever Injection 269——
Grade 3 Fever > 103.1°F01——
Any Solicited Vomiting Injection 247——
Grade 3 Vomiting ≥ 6 episodes per 24 hours00——
Any Solicited Crying Abnormal Injection 21916——
Grade 3 Crying Abnormal >3 hours12——
Any Solicited Drowsiness Injection 21323——
Grade 3 Drowsiness Sleeping most of the time00——
Any Solicited Appetite Lost Injection 21817——
Grade 3 Appetite Lost refuses most feeds11——
Any Solicited Irritability Injection 23030——
Grade 3 Irritability inconsolable34——
SecondaryNumber of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds

Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.

Time frame:
Day 0 to Day 7 post-vaccination
Reported as:
Number · Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
ParticipantsGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Any injection site Pain Injection 1——9389
Grade 3 Pain (Reduced movement)——00
Any Injection site Redness Injection 1——9842
Grade 3 Redness ( ≥ 5 cm)——21
Any Injection site Swelling Injection 1——5930
Grade 3 Swelling ( ≥ 5 cm)——10
Any Injection site Induration Injection 1——5625
Grade 3 Induration ( ≥ 5 cm)——10
Any Injection site Ecchymosis Injection 1——1819
Grade 3 Ecchymosis ( ≥ 5 cm)——01
Any Solicited Pruritus Injection 1——2311
Any injection site pain Injection 2——9890
Grade 3 Pain (Reduced movement)——01
Any Injection site Redness Injection 2——9440
Grade 3 Redness (≥ 5 cm)——11
Any Injection site Swelling Injection 2——6121
Grade 3 swelling ( ≥ 5 cm)——10
Any Injection site Induration Injection 2——5017
Grade 3 Induration (≥ 5 cm)——10
Any Injection site Ecchymosis Injection 2——1822
Grade 3 Ecchymosis (≥ 5 cm)——00
Any Solicited Pruritus Injection 2——1519
Any Solicited Fever Injection 1——1018
Grade 3 Fever > 102.2°F——23
Any Solicited Headache Injection 1——2225
Grade 3 Headache Prevents daily activities——11
Any Solicited Malaise Injection 1——2130
Grade 3 Malaise Prevents daily activities——12
Any Solicited Myalgia Injection 1——2442
Grade 3 Myalgia Prevents daily activities——00
Any Solicited Fever Injection 2——1614
Grade 3 Fever > 102.2°F——02
Any Solicited Headache Injection 2——1517
Grade 3 Headache Prevents daily activities——22
Any Solicited Malaise Injection 2——2421
Grade 3 Malaise Prevents daily activities——11
Any Solicited Myalgia Injection 2——2425
Grade 3 Myalgia Prevents daily activities——20

Adverse events

Collected over Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Fluzone ID at Age 6 to 35 Months—1/97 (1%)51/97 (52.6%)
Group 2: Fluzone IM 6 to 35 Months Age Group—1/97 (1%)49/97 (50.5%)
Group 3: Fluzone ID at 3 to 8 Years Age—1/160 (0.6%)98/160 (61.3%)
Group 4: Fluzone IM 3 to 8 Years Age—1/163 (0.6%)90/163 (55.2%)
Most frequent serious events
Most frequent serious events
EventGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Gastroenteritis viralInfections and infestations0/971/970/1600/163
DehydrationMetabolism and nutrition disorders1/970/970/1600/163
Viral infectionInfections and infestations0/970/971/1600/163
AutismNervous system disorders0/970/970/1601/163
Most frequent other events
Showing 10 of 32
Most frequent other events
EventGroup 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years Age
Injection site TendernessGeneral disorders51/9349/8798/13790/145
Injection site RednessGeneral disorders48/9328/8798/14342/151
Injection site SwellingGeneral disorders23/8815/9061/13730/151
IrritabilityNervous system disorders37/9339/910/1600/163
Injection site IndurationGeneral disorders24/9314/8756/14325/151
CoughRespiratory, thoracic and mediastinal disorders33/9732/9746/16042/163
Crying abnormalPsychiatric disorders17/9329/910/1600/163
MyalgiaGeneral disorders0/970/9724/14142/150
DrowsinessNervous system disorders21/9324/910/1600/163
Injection site EcchymosisGeneral disorders23/8813/8718/14322/145

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years AgeTotal
<=18 years9797160163517
Between 18 and 65 years00000
>=65 years00000
Age Continuous
Age Continuous(Months)Group 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years AgeTotal
Mean22.6 ± 7.5121.8 ± 8.0369.6 ± 22.270.8 ± 21.646.5 ± 14.835
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years AgeTotal
Female45437084242
Male52549079275
Region of Enrollment
Region of Enrollment(Participants)Group 1: Fluzone ID at Age 6 to 35 MonthsGroup 2: Fluzone IM 6 to 35 Months Age GroupGroup 3: Fluzone ID at 3 to 8 Years AgeGroup 4: Fluzone IM 3 to 8 Years AgeTotal
United States9797160163517
08

Study locations

19 sites
  • Harrisburg, Arkansas 72432, United States
  • Little Rock, Arkansas 72205, United States
  • Trumann, Arkansas 72472, United States
  • Bellflower, California 90706, United States
  • Downey, California 90241, United States
  • Fountain Valley, California 92708, United States
  • Paramount, California 90723, United States
  • Owensboro, Kentucky 42303, United States
  • Bossier City, Louisiana 71111, United States
  • Shreveport, Louisiana 71105, United States
  • Brainerd, Minnesota 56401, United States
  • Cleveland, Ohio 44121, United States
  • Erie, Pennsylvania 16505, United States
  • Pittsburgh, Pennsylvania 15277, United States
  • Uniontown, Pennsylvania 15401, United States
  • Wexford, Pennsylvania 15090, United States
  • Fort Worth, Texas 76107, United States
  • Salt Lake City, Utah 84109, United States
  • Salt Lake City, Utah 84121, United States
09

References and documents

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00391391
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Oct 24, 2006
Start date
Oct 2006
Primary completion
Mar 2007
Completion
Oct 2007
Results posted
Nov 22, 2011
Last update
Dec 1, 2011

Study contacts

Medical Director
study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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