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CompletedNCT00952419Updated Apr 14, 2016Results posted

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

A Phase 2 interventional study of Monovalent Subvirion A/H1N1 Influenza vaccine and Monovalent Subvirion A/H1N1 Influenza vaccine in Influenza and Swine-origin A/H1N1 Influenza, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 20 sites in United States. Open to participants aged 6 Months to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
474
Allocation
Randomized
Ages
6 Months to 9 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

  • To describe the immunogenicity of the candidate vaccines after each injection.
  • To describe the safety of the candidate vaccines after each injection.
Read the detailed description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

02

Conditions studied

  • Influenza
  • Swine-origin A/H1N1 Influenza

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Keywords

  • Influenza
  • Pandemic Flu
  • Swine-origin A/H1N1 Influenza
  • Children
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 474 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

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

04

Who can participate

Ages eligible
6 Months to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

All subjects:

  • Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures

Subjects aged 3 to 9 years:

  • Healthy children aged 3 to 9 years on the day of inclusion

Subjects aged 6 to 35 months:

  • Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

Exclusion criteria

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine prior to the Day 42 blood sample
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
  • Known or suspected 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 (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
  • Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
  • Personal or family history of Guillain-Barré syndrome
  • Active neoplastic disease or a history of any hematologic malignancy
  • Known seizure/epilepsy history and/or taking anti-seizure medication
  • Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
  • Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
474 participants (actual)

Study arms

  • Experimental
    A/H1N1 Vaccine Group 1

    Participants will receive A/H1N1 vaccine formulation 1

    Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

  • Experimental
    A/H1N1 Vaccine Group 2

    Participants will receive A/H1N1 vaccine formulation 2

    Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

  • Placebo comparator
    Placebo Group

    Participants will receive a placebo vaccine

    Biological: Normal saline solution (placebo)

Interventions

  • BiologicalMonovalent Subvirion A/H1N1 Influenza vaccine

    0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)

  • BiologicalMonovalent Subvirion A/H1N1 Influenza vaccine

    0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)

  • BiologicalNormal saline solution (placebo)

    0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)

06

What researchers measure

Primary outcomes

  1. Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

    Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

    Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination

  2. Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

    Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

    Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination

  3. Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

    Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination

  4. Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

    Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination

  5. Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

    Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

    Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination

  6. Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

    Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination

  7. Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months

    Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.

    Time frame: Days 0 to 7 post-vaccination

  8. Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months

    Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.

    Time frame: Days 0 to 7 post-vaccination

  9. Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years

    Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.

    Time frame: Days 0 to 7 post vaccination

07

Results

Posted Jul 11, 2011

Participant flow

Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.

Participant flow — Overall Study
MilestoneA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Started21520851
Completed20919851
Not completed6100
Withdrew: Adverse event200
Withdrew: Protocol violation370
Withdrew: Withdrawal by subject130

Outcome measures

PrimaryNumber of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Time frame:
Pre-vaccination (Day 0) and 21 days post-vaccination
Reported as:
Number · Participants
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil520
Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil72790
Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil90871
PrimaryNumber of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

Time frame:
Pre-vaccination (Day 0) and Day 21 post-vaccination
Reported as:
Number · Participants
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil520
Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil43420
Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil84861
PrimaryGeometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Time frame:
Pre-vaccination (Day 0) and 21 days post-vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
TitersA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Pre-Vaccination 1 (Day 0) GMT5.99 (5.10 to 7.04)5.48 (4.84 to 6.20)5.00 (5.00 to 5.00)
Post-Vaccination 1 (Day 21) GMT33.3 (23.8 to 46.5)45.1 (32.8 to 62.0)5.08 (4.92 to 5.24)
Post-Vaccination 2 (Day 42) GMT368 (271 to 500)586 (451 to 763)5.64 (4.39 to 7.24)
PrimaryNumber of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Time frame:
Pre-vaccination (Day 0) and 21 days post-vaccination
Reported as:
Number · Participants
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil747
Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil91888
Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil98918
PrimaryNumber of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

Time frame:
Pre-vaccination (Day 0) and Day 21 post-vaccination
Reported as:
Number · Participants
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil535
Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil64685
Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil95906
PrimaryGeometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

Time frame:
Pre-vaccination (Day 0) and Day 21 post-vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
TitersA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Pre-Vaccination 1 (Day 0) GMT6.01 (5.20 to 6.94)5.54 (5.03 to 6.10)11.9 (6.17 to 22.9)
Post-Vaccination 1 (Day 21) GMT74.8 (53.5 to 105)104 (77.1 to 140)12.1 (6.53 to 22.3)
Post-Vaccination 2 (Day 42) GMT459 (348 to 605)586 (454 to 756)14.3 (7.02 to 29.3)
PrimaryNumber of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months

Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.

Time frame:
Days 0 to 7 post-vaccination
Reported as:
Number · Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Any Solicited Injection Site Reaction - Any Dose332311
Grade (Grd) 3 Injection Site Reaction - Any Dose110
Any Tenderness - Post Dose 124145
Any Tenderness - Post Dose 219117
Any Tenderness - Any Dose282010
Grd 3 Tenderness-Crying or movement less, Any Dose010
Any Erythema - Post Dose 11341
Any Erythema - Post Dose 21252
Any Erythema - Any Dose1973
Grade 3 Erythema (≥ 5 cm) Any Dose000
Any Swelling - Post Dose 1450
Any Swelling - Post Dose 2331
Any Swelling - Any Dose661
Grade 3 Swelling (≥ 5 cm) Any Dose000
Any Induration - Post Dose 1631
Any Induration - Post Dose 2430
Any Induration - Any Dose651
Grade 3 Induration (≥ 5 cm) Any Dose000
Any Ecchymosis - Post Dose 1330
Any Ecchymosis - Post Dose 2220
Any Ecchymosis - Any Dose440
Grade 3 Ecchymosis (≥ 5 cm) Any Dose100
Any Solicited Systemic Reaction - Any Dose313211
Any Grade 3 Solicited Systemic Reaction - Any Dose340
Any Fever - Post Dose 1620
Any Fever - Post Dose 2051
Any Fever - Any Dose661
Grade 3 Fever ( ≥102.1 ºF or ≥39.0 ºC) - Any Dose010
Any Vomiting - Post Dose 1140
Any Vomiting - Post Dose 2230
Any Vomiting - Any Dose360
Grade 3 Vomiting (> 6 episodes/24 hr) Any Dose030
Any Crying Abnormal - Post Dose 117125
Any Crying Abnormal - Post Dose 2894
Any Crying Abnormal - Any Dose20147
Grade 3 Crying Abnormal (>3 hr) Any Dose320
Any Drowsiness - Post Dose 18113
Any Drowsiness - Post Dose 2872
Any Drowsiness - Any Dose11113
Grade 3 Drowsiness (Sleeps most of time) Any Dose010
Any Appetite Lost - Post Dose 18123
Any Appetite Lost - Post Dose 2593
Any Appetite Lost - Any Dose10144
Grd 3 Appetite Lost (Refused 3 meals) Any Dose010
Any Irritability - Post Dose 123227
Any Irritability - Post Dose 214176
Any Irritability - Any Dose26259
Grade 3 Irritability (Inconsolable) Any Dose020
PrimaryNumber of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months

Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.

Time frame:
Days 0 to 7 post-vaccination
Reported as:
Number · Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Any Solicited Injection Site Reaction - Any Dose19205
Grade (Grd) 3 Injection Site Reaction - Any Dose020
Any Pain - Post Dose 112123
Any Pain - Post Dose 210162
Any Pain - Any Dose17193
Grade 3 Pain (Incapacitating) - Any Dose020
Any Erythema - Post Dose 1573
Any Erythema - Post Dose 2391
Any Erythema - Any Dose6123
Grade 3 Erythema (≥ 5 cm) Any Dose000
Any Swelling - Post Dose 1130
Any Swelling - Post Dose 2030
Any Swelling - Any Dose140
Grade 3 Swelling (≥ 5 cm) Any Dose000
Any Induration - Post Dose 1241
Any Induration - Post Dose 2131
Any Induration - Any Dose261
Grade 3 Induration (≥ 5 cm) Any Dose000
Any Ecchymosis - Post Dose 1132
Any Ecchymosis - Post Dose 2230
Any Ecchymosis - Any Dose362
Grade 3 Ecchymosis (≥ 5 cm) Any Dose000
Any Solicited Systemic Reaction - Any Dose14133
Any Grade 3 Solicited Systemic Reaction - Any Dose121
Any Fever - Post Dose 1111
Any Fever - Post Dose 2310
Any Fever - Any Dose421
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) -Any Dose111
Any Headache - Post Dose 1111
Any Headache - Post Dose 2011
Any Headache - Any Dose121
Grd 3 Headache (Prevents daily activity) Any Dose000
Any Malaise - Post Dose 1763
Any Malaise - Post Dose 2562
Any Malaise - Any Dose1093
Grd 3 Malaise (Prevents daily activity) Any Dose110
Any Myalgia - Post Dose 1432
Any Myalgia - Post Dose 2022
Any Myalgia - Any Dose452
Grd 3 Myalgia (Prevents Daily Activity) Any Dose000
Any Shivering - Post Dose 1110
Any Shivering - Post Dose 2000
Any Shivering - Any Dose110
Grade 3 Shivering (Prevents activity) - Any Dose000
PrimaryNumber of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years

Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.

Time frame:
Days 0 to 7 post vaccination
Reported as:
Number · Participants
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
ParticipantsA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Any Solicited Injection Site Reaction - Any Dose705916
Grade 3 Injection Site Reaction - Any Dose330
Any Pain - Post Dose 1484212
Any Pain - Post Dose 234318
Any Pain - Any Dose635416
Grade 3 Pain (Incapacitating) - Any Dose200
Any Erythema - Post Dose 114142
Any Erythema - Post Dose 21052
Any Erythema - Any Dose19152
Grade 3 Erythema (≥ 5 cm) Any Dose110
Any Swelling - Post Dose 15101
Any Swelling - Post Dose 2530
Any Swelling - Any Dose8111
Grade 3 Swelling (≥ 5 cm) Any Dose130
Any Induration - Post Dose 1784
Any Induration - Post Dose 2720
Any Induration - Any Dose1184
Grade 3 Induration (≥ 5 cm) Any Dose100
Any Ecchymosis - Post Dose 1991
Any Ecchymosis - Post Dose 2641
Any Ecchymosis - Any Dose13112
Grade 3 Ecchymosis (≥ 5 cm) Any Dose000
Any Solicited Systemic Reaction - Any Dose513812
Any Grade 3 Solicited Systemic Reaction - Any Dose572
Any Fever - Post Dose 1211
Any Fever - Post Dose 2451
Any Fever - Any Dose662
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose131
Any Headache - Post Dose 115115
Any Headache - Post Dose 213103
Any Headache - Any Dose23197
Gr 3 Headache (Prevents daily activity) Any Dose040
Any Malaise - Post Dose 118127
Any Malaise - Post Dose 216145
Any Malaise - Any Dose292410
Gr 3 Malaise (Prevents daily activity) Any Dose361
Any Myalgia - Post Dose 11991
Any Myalgia - Post Dose 214113
Any Myalgia - Any Dose32183
Gr 3 Malaise (Prevents daily activity) Any Dose200
Any Shivering - Post Dose 1131
Any Shivering - Post Dose 2051
Any Shivering - Any Dose182
Grade 3 Shivering (Prevents activity) - Any Dose120

Adverse events

Collected over Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A/H1N1 Vaccine Group 1—1/219 (0.5%)110/219 (50.2%)
A/H1N1 Vaccine Group 2—0/204 (0%)104/204 (51%)
Placebo Group—1/51 (2%)27/51 (52.9%)
Most frequent serious events
Most frequent serious events
EventA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Humerus fractureInjury, poisoning and procedural complications0/2190/2041/51
FuruncleInfections and infestations1/2190/2040/51
Most frequent other events
Showing 10 of 20
Most frequent other events
EventA/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo Group
Injection site painGeneral disorders80/15673/14519/33
Injectiuon site tendernessGeneral disorders28/6120/5510/18
IrritabilityPsychiatric disorders26/6125/559/18
MalaiseGeneral disorders39/15633/14513/33
Crying abnormalPsychiatric disorders20/6114/557/18
Appetite lostMetabolism and nutrition disorders10/6114/554/18
HeadacheNervous system disorders24/15621/1458/33
MyalgiaMusculoskeletal and connective tissue disorders36/15623/1455/33
Injection site erythemaGeneral disorders44/21734/2018/51
DrowsinessNervous system disorders11/6111/553/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)A/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo GroupTotal
<=18 years21520851474
Between 18 and 65 years0000
>=65 years0000
Age, Continuous
Age, Continuous(Years)A/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo GroupTotal
Mean4.1 ± 2.84.3 ± 2.83.7 ± 2.74.2 ± 2.8
Sex: Female, Male
Sex: Female, Male(Participants)A/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo GroupTotal
Female1119924234
Male10410927240
Region of Enrollment
Region of Enrollment(participants)A/H1N1 Vaccine Group 1A/H1N1 Vaccine Group 2Placebo GroupTotal
United States21520851474
08

Study locations

20 sites
  • Miami Beach, Florida 33141, United States
  • Marietta, Georgia 30062, United States
  • Woodstock, Georgia 30189, United States
  • Crestview Hills, Kentucky 41017, United States
  • Louisville, Kentucky 40291, United States
  • Maddisonville, Kentucky 42431, United States
  • Metairie, Louisiana 70006, United States
  • Las Vegas, Nevada 89104, United States
  • Rochester, New York 14609, United States
  • Hermitage, Pennsylvania 16148, United States
  • Pittsburgh, Pennsylvania 15237, United States
  • Pittsburgh, Pennsylvania 15241, United States
  • Cranston, Rhode Island O2920, United States
  • Barnwell, South Carolina 29812, United States
  • Austin, Texas 78705, United States
  • Fort Worth, Texas 76135, United States
  • San Angelo, Texas 76904, United States
  • Orem, Utah 84057, United States
  • South Jordan, Utah 84095, United States
  • Springville, Utah 84663, United States
09

References and documents

Publications

  • Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8. PubMed 21219979 ↗
  • Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15. PubMed 20018365 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00952419
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Aug 6, 2009
Start date
Aug 2009
Primary completion
Mar 2010
Completion
Jun 2010
Results posted
Jul 11, 2011
Last update
Apr 14, 2016

Study contacts

Medical Monitor
study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

Sanofi Pasteur, a Sanofi Company

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