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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:
NCT00963430
First received: August 20, 2009
Last updated: November 29, 2012
Last verified: April 2010
History of Changes
Results First Received: April 21, 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
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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
No text entered.

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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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  
Number of Participants  
[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
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]
  Show Outcome Measure 3

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

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

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

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

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

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

11.  Primary:   Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery   [ Time Frame: At time of delivery ]
  Show Outcome Measure 11

12.  Primary:   Number of Participants Reporting Neonatal Complications   [ Time Frame: At time of delivery ]
  Hide Outcome Measure 12

Measure Type Primary
Measure Title Number of Participants Reporting Neonatal Complications
Measure Description Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.
Time Frame At time of delivery  
Safety Issue Yes  

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.
All live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, each counted separately.

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  
Number of Participants Analyzed  
[units: participants]
 		  61     62  
Number of Participants Reporting Neonatal Complications  
[units: Participants]
 		   
Pre-term (less than 37 weeks)     10     7  
Large for gestational age     12     3  
Small for gestational age     3     1  
Abnormal infant exam     15     13  
Congenital abnormalities     1     3  
Hematological complications     3     1  
Infection     0     0  
Sepsis     0     0  
Meningitis     0     0  
Metabolic complications     4     0  
Respiratory complications     6     3  
Respiratory support used     5     3  
Fever 100.4 degrees Fahrenheit or greater     0     0  
Admission to special nursery/infant intensive care     6     6  

No statistical analysis provided for Number of Participants Reporting Neonatal Complications



13.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after last vaccination ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17


  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
No text entered.  


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


No publications provided


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00963430     History of Changes
Other Study ID Numbers: 09-0056, N01AI80004C
Study First Received: August 20, 2009
Results First Received: April 21, 2011
Last Updated: November 29, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board