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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
Results First Received: April 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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
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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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
  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 ]

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

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

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

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

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

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

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

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 ]

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 ]

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

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

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

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Additional Description For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    15 Mcg H1N1 Vaccine   30 Mcg H1N1 Vaccine
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   53/60 (88.33%)   54/60 (90.00%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   0/60 (0.00%)   4/60 (6.67%) 
# events   0   4 
Gastrointestinal disorders     
Dyspepsia * 1     
# participants affected / at risk   0/60 (0.00%)   3/60 (5.00%) 
# events   0   4 
Nausea † 1     
# participants affected / at risk   10/60 (16.67%)   14/60 (23.33%) 
# events   12   16 
General disorders     
Feeling hot † 1     
# participants affected / at risk   7/60 (11.67%)   8/60 (13.33%) 
# events   7   8 
Malaise † 1     
# participants affected / at risk   23/60 (38.33%)   28/60 (46.67%) 
# events   27   38 
Injection site pain † 1     
# participants affected / at risk   21/60 (35.00%)   31/60 (51.67%) 
# events   25   41 
Tenderness † 1 [4]     
# participants affected / at risk   37/60 (61.67%)   44/60 (73.33%) 
# events   52   74 
Injection site erythema † 1     
# participants affected / at risk   6/60 (10.00%)   9/60 (15.00%) 
# events   7   11 
Injection site swelling † 1     
# participants affected / at risk   5/60 (8.33%)   1/60 (1.67%) 
# events   5   1 
Infections and infestations     
Upper respiratory tract infection * 1     
# participants affected / at risk   8/60 (13.33%)   10/60 (16.67%) 
# events   8   11 
Urinary tract infection * 1     
# participants affected / at risk   2/60 (3.33%)   3/60 (5.00%) 
# events   2   3 
Musculoskeletal and connective tissue disorders     
Back pain * 1     
# participants affected / at risk   4/60 (6.67%)   3/60 (5.00%) 
# events   4   3 
Myalgia † 1     
# participants affected / at risk   15/60 (25.00%)   11/60 (18.33%) 
# events   15   14 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   23/60 (38.33%)   24/60 (40.00%) 
# events   28   29 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1     
# participants affected / at risk   2/60 (3.33%)   3/60 (5.00%) 
# events   2   3 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (13.0)
[4] Tenderness was solicited as a reaction at the vaccination site.



  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