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: August 1, 2013
Last verified: July 2010
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


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

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

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

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

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

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

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

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  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
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.


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