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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

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

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.
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.
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

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 ]
  Show Outcome Measure 12

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 ]
  Hide Outcome Measure 16

Measure Type Secondary
Measure Title 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
Measure Description Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 21 after the second 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 both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 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   38   51 
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 
[Units: Participants]
 		 36   47 

No statistical analysis provided for 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



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


  Other Adverse Events


  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.


  More Information