H1N1 Vaccine in Pregnant Women

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ClinicalTrials.gov Identifier: NCT00963430

Recruitment Status : Completed

First Posted : August 21, 2009

Results First Posted : May 16, 2011

Last Update Posted : December 3, 2012

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza
Intervention:	Biological: Inactivated H1N1 Vaccine

Participant Flow

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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 pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Sep2009 and 16Oct2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

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

Participant Flow: Overall Study

	15 Mcg H1N1 Vaccine	30 Mcg H1N1 Vaccine
STARTED	60	60
COMPLETED	59	57
NOT COMPLETED	1	3

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

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

Baseline Measures

	15 Mcg H1N1 Vaccine	30 Mcg H1N1 Vaccine	Total
Overall Participants Analyzed [Units: Participants]	60	60	120

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	60	60	120
>=65 years	0	0	0

Age [Units: Years] Mean (Standard Deviation)	31.7 (4.3)	31.2 (4.3)	31.4 (4.3)

Gender [Units: Participants]
Female	60	60	120
Male	0	0	0

Region of Enrollment [Units: Participants]
United States	60	60	120

Outcome Measures

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1. Primary:

Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

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2. Primary:

Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

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3. Primary:

Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

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4. Primary:

Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

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5. Primary:

Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

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6. Primary:

Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

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7. Primary:

Number of Participants Reporting Fever After First Vaccination [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

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8. Primary:

Number of Participants Reporting Fever After Second Vaccination [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

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9. Primary:

Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 21 after the first vaccination ]

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10. Primary:

Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ]

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Measure Type	Primary
Measure Title	Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine
Measure Description	Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame	Day 21 after the first vaccination

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.

Reporting Groups

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

Measured Values

	15 Mcg H1N1 Vaccine	30 Mcg H1N1 Vaccine
Participants Analyzed [Units: Participants]	55	58
Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine [Units: Participants]	51	56

No statistical analysis provided for Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine

11. Primary:

Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery [ Time Frame: At time of delivery ]

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12. Primary:

Number of Participants Reporting Neonatal Complications [ Time Frame: At time of delivery ]

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13. Primary:

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

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14. Secondary:

Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery [ Time Frame: At time of delivery ]

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15. Secondary:

Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood [ Time Frame: At time of delivery ]

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16. Secondary:

Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

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17. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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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.

Results Point of Contact:

Name/Title: Lisa Jackson, MD, MPH
Organization: Group Health Research Institute
phone: 206-442-5216

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00963430 History of Changes
Other Study ID Numbers:	09-0056 N01AI80004C
First Submitted:	August 20, 2009
First Posted:	August 21, 2009
Results First Submitted:	April 21, 2011
Results First Posted:	May 16, 2011
Last Update Posted:	December 3, 2012

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