Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00943631

First received: July 21, 2009

Last updated: October 25, 2012

Last verified: March 2010

History of Changes

Results First Received: March 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza
Intervention:	Biological: Inactivated H1N1 Vaccine

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 07AUG2009 and 18AUG2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
H1N1 Vaccine 15 Mcg	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Participant Flow: Overall Study

	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
STARTED	202	204
COMPLETED	198	202
NOT COMPLETED	4	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
H1N1 Vaccine 15 Mcg	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Total	Total of all reporting groups

Baseline Measures

	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg	Total
Number of Participants [units: participants]	202	204	406
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	102	100	202
>=65 years	100	104	204
Age [units: years] Mean ± Standard Deviation	58.7 ± 17.1	59.6 ± 16.4	59.1 ± 16.7
Gender [units: participants]
Female	103	112	215
Male	99	92	191
Region of Enrollment [units: participants]
United States	202	204	406

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [ Time Frame: Day 0 through Day 180 after last vaccination ]

Show Outcome Measure 1

2. Primary:

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Show Outcome Measure 2

3. Primary:

Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Show Outcome Measure 3

4. Primary:

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Show Outcome Measure 4

5. Primary:

Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Show Outcome Measure 5

6. Primary:

Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Show Outcome Measure 6

7. Primary:

Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Show Outcome Measure 7

8. Primary:

Number of Participants Reporting Fever After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ]

Show Outcome Measure 8

9. Primary:

Number of Participants Reporting Fever After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ]

Show Outcome Measure 9

10. Primary:

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [ Time Frame: Baseline and Day 8-10 after first vaccination ]

Show Outcome Measure 10

11. Primary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [ Time Frame: Baseline and Day 8-10 after first vaccination ]

Show Outcome Measure 11

12. Primary:

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [ Time Frame: Baseline and Day 21 after first vaccination ]

Show Outcome Measure 12

13. Primary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [ Time Frame: Baseline and Day 21 after first vaccination ]

Show Outcome Measure 13

14. Primary:

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Show Outcome Measure 14

15. Primary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

Show Outcome Measure 15

16. Primary:

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 21 after first vaccination ]

Show Outcome Measure 16

17. Primary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 21 after first vaccination ]

Show Outcome Measure 17

18. Secondary:

Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine [ Time Frame: Baseline and Day 8-10 and 21 after the second vaccination ]

Show Outcome Measure 18

19. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine [ Time Frame: Baseline and Day 8-10 after the second vaccination ]

Show Outcome Measure 19

20. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine [ Time Frame: Baseline and Day 21 after the second vaccination ]

Show Outcome Measure 20

21. Secondary:

Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine [ Time Frame: Day 8-10 and Day 21 after the second vaccination ]

Show Outcome Measure 21

22. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine [ Time Frame: Day 8-10 after the second vaccination ]

Show Outcome Measure 22

23. Secondary:

Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ]

Show Outcome Measure 23

Serious Adverse Events

Hide Serious Adverse Events

Time Frame	Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Additional Description	For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Reporting Groups

	Description
H1N1 Vaccine 15 Mcg	Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg	Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Serious Adverse Events

	H1N1 Vaccine 15 Mcg	H1N1 Vaccine 30 Mcg
Total, serious adverse events
# participants affected / at risk	6/202 (2.97%)	5/204 (2.45%)
Cardiac disorders
Ischaemic cardiomyopathy ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0
Atrial fibrillation ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
Gastrointestinal disorders
Umbilical hernia, obstructive ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
General disorders
Chest pain ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
Infections and infestations
Clostridium difficile colitis ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0
Injury, poisoning and procedural complications
Post procedural complication ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0
Musculoskeletal and connective tissue disorders
Osteoarthritis ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0
Nervous system disorders
Syncope ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
Renal and urinary disorders
Renal cyst ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0
Urinary incontinence ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
Pulmonary embolism ^{* 1}
# participants affected / at risk	0/202 (0.00%)	1/204 (0.49%)
# events	0	1
Surgical and medical procedures
Thoracotomy ^{* 1}
# participants affected / at risk	1/202 (0.50%)	0/204 (0.00%)
# events	1	0

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (13.0)

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Karen Kotloff, MD
Organization: Center for Vaccine Development, University of Maryland
phone: 401-706-5328
e-mail: kkotloff@medicine.umaryland.edu

Publications of Results:

Chen WH, Winokur PL, Edwards KM, Jackson LA, Wald A, Walter EB, Noah DL, Wolff M, Kotloff KL; Pandemic H1N1 Vaccine Adult Study Group. Phase 2 assessment of the safety and immunogenicity of two inactivated pandemic monovalent H1N1 vaccines in adults as a component of the U.S. pandemic preparedness plan in 2009. Vaccine. 2012 Jun 13;30(28):4240-8. Epub 2012 Apr 23.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00943631 History of Changes
Other Study ID Numbers:	09-0053, N01AI80057C
Study First Received:	July 21, 2009
Results First Received:	March 17, 2011
Last Updated:	October 25, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board

To Top