Novartis H1N1 Vaccine in Pregnant Women

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00992719

First received: October 8, 2009

Last updated: May 10, 2012

Last verified: July 2010

History of Changes

Results First Received: January 19, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; 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 and non-pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Nov2009 and 04May2010.

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
Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine	Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine	Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine	Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0

Participant Flow: Overall Study

	Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine	Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine	Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine
STARTED	28	28	28
COMPLETED	27	27	28
NOT COMPLETED	1	1	0

Baseline Characteristics

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Outcome Measures

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1. Primary:

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

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2. Primary:

Number of Births With Neonatal Complications [ Time Frame: At time of delivery ]

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. 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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9. 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 0 prior to and Day 21 following vaccination ]

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10. 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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11. 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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Serious Adverse Events

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Other Adverse Events

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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.

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
Although 200 pregnant and 100 non-pregnant subjects were targeted for enrollment, enrollment closed in May 2010 prior to reaching the target due to slow accrual.

Results Point of Contact:

Name/Title: Geeta K. Swamy, M.D.
Organization: Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine, Duke University School of Medicine
phone: 919-681-5220
e-mail: geeta.swamy@duke.edu

No publications provided

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00992719 History of Changes
Other Study ID Numbers:	09-0072, N01AI80057C
Study First Received:	October 8, 2009
Results First Received:	January 19, 2012
Last Updated:	May 10, 2012
Health Authority:	United States: Federal Government United States: Institutional Review Board United States: Food and Drug Administration

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