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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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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
Total Total of all reporting groups

Baseline Measures
    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     Total  
Number of Participants  
[units: participants]
 		  28     28     28     84  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     28     28     28     84  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  30  ± 6.0     28.8  ± 4.9     30.8  ± 5.6     29.9  ± 5.5  
Gender  
[units: participants]
 		       
Female     28     28     28     84  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     28     28     28     84  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery   [ Time Frame: At time of delivery ]
  Show Outcome Measure 1

2.  Primary:   Number of Births With Neonatal Complications   [ Time Frame: At time of delivery ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after vaccination ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination   [ Time Frame: Within 8 days post vaccination (Day 0-7) ]
  Show Outcome Measure 4

5.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination   [ Time Frame: Within 8 days post vaccination (Day 0-7) ]
  Show Outcome Measure 5

6.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination   [ Time Frame: Within 8 days post vaccination (Day 0-7) ]
  Show Outcome Measure 6

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

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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 ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title 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
Measure Description Cord blood was collected at the time of delivery 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 At time of delivery  
Safety Issue No  

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.
Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.

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

Measured Values
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
 		  22     22  
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  
[units: participants]
 		  17     18  

No statistical analysis provided for 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




  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:
unchecked 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.
unchecked 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