CompletedNCT00858468Updated Apr 14, 2016Results posted

Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

A Phase 1/2 interventional study of Influenza virus vaccine (2004-2005 Formulation) and Influenza virus vaccine (2004-2005 Formulation) in Influenza, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 8 sites in United States. Open to participants aged 2 Months to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 394
Allocation: Randomized
Ages: 2 Months to 9 Months
Sex: All

Study summary

Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Read the detailed description

This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Influenza vaccine

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 394 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

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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.

Who can participate

Ages eligible: 2 Months to 9 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
Considered to be in good health on the basis of reported medical history and history-directed physical examination.
Available for the duration of the study.
Parent/guardian willing and able to provide informed consent.
Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.

Exclusion criteria

Exclusion Criteria :

Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
Previous history of influenza vaccination or documented history of influenza infection.
Receipt of any vaccine in the 7 days prior to enrollment.
An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
Known bleeding disorder.
Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
Personal or immediate family history of congenital immune deficiency.
Developmental delay, neurologic disorder, or seizure disorder.
Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
Known HIV-positive or HBsAg-positive mother.
Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
Blood or blood-derived products received in the past 2 months.
Prior history of Guillain-Barré syndrome.
Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 394 participants (actual)

Study arms

Experimental
Group 1
Participants aged 6 to 12 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
Experimental
Group 2
Participants aged 24 to 36 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)

Interventions

BiologicalInfluenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Also known as: Fluzone® Preservative-free
BiologicalInfluenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Also known as: Fluzone® Preservative-free

What researchers measure

Primary outcomes

Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
Time frame: Day 0 to Day 7 post-vaccination

Other outcomes

Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).
Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40
Time frame: 21 days post-vaccination 2
Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).
Seroconversion was defined as the percentage of participants with a pre-titer \< 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.
Time frame: 21 days post-vaccination 2
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.
Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.
Time frame: 21 days post-vaccination 2

Results

Posted Jul 31, 2009

Participant flow

Participants were enrolled from 08 April to 05 August 2005 in 8 medical centers in the US

Participant flow — Overall Study
Milestone	Age 6 to 12 Weeks	Age 24 to 36 Weeks
Started	201	192
Completed	201	192
Not completed	0	0

Outcome measures

PrimaryPercentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.

Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.

Time frame:: Day 0 to Day 7 post-vaccination
Reported as:: Number · Percentage of participants

Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Percentage of participants	Age 6 to 12 Weeks	Age 24 to 36 Weeks
Any Solicited Injection Site Reaction - Dose 1	54	47
Any Tenderness	50	44
Grd 3 Tenderness-Inj. Limb movement reduced	6	2
Any Redness	11	7
Grade 3 Redness (≥ 5.0 cm)	0	0
Any Swelling	8	5
Grade 3 Swelling (≥ 5.0 cm)	0	0
Any Solicited Injection Site Reaction - Dose 2	41	27
Any Tenderness	38	26
Grd 3 Tenderness-Inj. Limb movement reduced	1	0
Any Redness	10	5
Grade 3 Redness (≥ 5.0 cm)	1	0
Any Swelling	5	2
Grade 3 Swelling (≥5.0 cm)	0	0
Any Solicited Injection Site Reaction - Any Doses	61	52
Any Tenderness	57	50
Grd 3 Tenderness-Inj. Limb movement reduced	7	2
Any Redness	16	10
Grade 3 Redness (≥ 5.0 cm)	1	0
Any Swelling	12	6
Grade 3 Swelling (≥ 5.0 cm)	0	0
Any Solicited Systemic Reaction Dose 1	90	82
Any Fever (Rectal Temp)	8	18
Grade 3 Fever (>39.5 ºC)	0	0
Any Vomiting	22	16
Grade 3 Vomiting (≥ 6 episodes per 24 hrs)	1	0
Any Abnormal Crying	59	45
Grade 3 Abnormal Crying	3	3
Any Drowsiness	72	50
Grade 3 Drowsiness (difficulty waking up)	2	1
Any Loss of Appetite	43	35
Grd 3 Loss of Appetite (refuses ≥ 3 meals)	0	2
Any Irritability	77	67
Grade 3 Irritability (inconsolable)	5	3
Any Solicited Systemic Reaction Dose 2	70	70
Any Fever (Rectal Temp)	4	14
Grade 3 Fever (>39.5 ºC)	0	2
Any Vomiting	14	8
Grade 3 Vomiting (≥ 6 episodes per 24 hrs)	1	0
Any Abnormal Crying	37	34
Grade 3 Abnormal Crying	4	1
Any Drowsiness	47	38
Grade 3 Drowsiness (difficulty waking up)	2	0
Any Loss of Appetite	28	27
Grade 3 Loss of Appetite (refuses ≥ 3 meals)	1	0
Any Irritability	55	53
Grade 3 Irritability (inconsolable)	3	1
Any Solicited Systemic Reaction Any Dose	92	89
Any Fever (Rectal Temp)	11	26
Grade 3 Fever (>39.5 ºC)	0	2
Any Vomiting	27	21
Grade 3 Vomiting (≥ 6 episodes per 24 hrs)	2	0
Any Abnormal Crying	66	55
Grade 3 Abnormal Crying	6	4
Any Drowsiness	78	58
Grade 3 Drowsiness (difficulty waking up)	4	1
Any Loss of Appetite	52	47
Grade 3 Loss of Appetite (refuses ≥ 3 meals)	1	2
Any Irritability	82	76
Grade 3 Irritability (inconsolable)	7	4

Other pre-specifiedPercentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).

Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40

Time frame:: 21 days post-vaccination 2
Reported as:: Number · Percentage of participants

Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).
Percentage of participants	Age 6 to 12 Weeks	Age 24 to 36 Weeks
A/NEW CALEDONIA/20/99 ≥ 40 Post-dose	46	69
A/WYOMING/03/2003 ≥ 40 Post-dose	59	78
B/JIANGSU/10/2003 ≥ 40 Post-dose	5	22

Other pre-specifiedPercentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).

Seroconversion was defined as the percentage of participants with a pre-titer \< 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.

Time frame:: 21 days post-vaccination 2
Reported as:: Number · Percentage of participants

Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).
Percentage of participants	Age 6 to 12 Weeks	Age 24 to 36 Weeks
A/NEW CALEDONIA/20/99, Pre-Dose ≤ 10	70	96
A/NEW CALEDONIA/20/99, Pre-Dose ≤10, Post-Dose ≥40	48	72
A/WYOMING/03/2003, Pre-Dose ≤ 10	32	74
A/WYOMING/03/2003, Pre-Dose ≤10, Post-Dose ≥40	60	86
FLU B/JIANGSU/10/2003, Pre-Dose ≤ 10	84	97
FLU B/JIANGSU/10/2003, Pre-Dose ≤10, Post-Dose ≥40	4	20

Other pre-specifiedGeometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.

Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.

Time frame:: 21 days post-vaccination 2
Reported as:: Geometric mean · Titers

Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.
Titers	Age 6 to 12 Weeks	Age 24 to 36 Weeks
A/NEW CALEDONIA/20/99 Pre-dose	11.5 (9.4 to 14.1)	5.7 (5.3 to 6.0)
A/NEW CALEDONIA/20/99 Post-dose	27.6 (23.1 to 33.1)	47.0 (39.3 to 56.2)
A/WYOMING/03/2003 Pre-dose	40.8 (31.2 to 53.2)	9.8 (8.1 to 11.9)
A/WYOMING/03/2003 Post-dose	46.3 (38.7 to 55.4)	90.9 (72.2 to 114.4)
B/JIANGSU/10/2003 Pre-dose	7.0 (6.3 to 7.8)	5.4 (5.1 to 5.7)
B/JIANGSU/10/2003 Post-dose	8.4 (7.5 to 9.3)	15.3 (12.9 to 18.2)

Adverse events

Collected over Adverse event data were collected for 6 months post-vaccination.. Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Age 6 to 12 Weeks	—	4/201 (2%)	54/201 (26.9%)
Age 24 to 36 Weeks	—	3/192 (1.6%)	94/192 (49%)

Most frequent serious events

Most frequent serious events
Event	Age 6 to 12 Weeks	Age 24 to 36 Weeks
Viral gastroenteritisGastrointestinal disorders	0/201	1/192
CellulitisInfections and infestations	0/201	1/192
Febrile convulsionNervous system disorders	0/201	1/192
Kawasaki's diseaseInfections and infestations	1/201	0/192
ChokingRespiratory, thoracic and mediastinal disorders	1/201	0/192
FeverInfections and infestations	1/201	0/192
BronchiolitisRespiratory, thoracic and mediastinal disorders	1/201	0/192

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Age 6 to 12 Weeks	Age 24 to 36 Weeks
PyrexiaGeneral disorders	5/201	19/192
Upper respiratory tract infectionInfections and infestations	13/201	19/192
TeethingGastrointestinal disorders	0/201	17/192
Otitis mediaInfections and infestations	3/201	16/192
CoughRespiratory, thoracic and mediastinal disorders	8/201	16/192
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	9/201	15/192
Nasal congestionRespiratory, thoracic and mediastinal disorders	13/201	3/192
DiarrhoeaGastrointestinal disorders	10/201	12/192
NasopharyngitisInfections and infestations	2/201	11/192
Injection site haemorrhageGeneral disorders	4/201	10/192

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Age 6 to 12 Weeks	Age 24 to 36 Weeks	Total
<=18 years	201	192	393
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(Weeks)	Age 6 to 12 Weeks	Age 24 to 36 Weeks	Total
Mean	9.4 ± 0.98	27.0 ± 1.31	18.0 ± 8.9

Sex: Female, Male
Sex: Female, Male(Participants)	Age 6 to 12 Weeks	Age 24 to 36 Weeks	Total
Female	98	99	197
Male	103	93	196

Region of Enrollment
Region of Enrollment(participants)	Age 6 to 12 Weeks	Age 24 to 36 Weeks	Total
United States	201	192	393

Study locations

8 sites

Little Rock, Arkansas 72205, United States
Marietta, Georgia 30062, United States
Durham, North Carolina 27705, United States
Akron, Ohio 44308, United States
Dayton, Ohio 45404, United States
Pittsburgh, Pennsylvania 15241, United States
Norfolk, Virginia 23510, United States
Seattle, Washington 98101, United States

References and documents

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 ↗

Registry details

Key details

Study ID: NCT00858468
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Mar 9, 2009
Start date: Apr 2005
Primary completion: Jun 2006
Completion: Dec 2006
Results posted: Jul 31, 2009
Last update: Apr 14, 2016

Study contacts

Medical Director

study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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