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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: August 1, 2013
Last verified: July 2010
Results First Received: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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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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 
Overall Participants Analyzed 
[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 ]

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 ]
  Hide Outcome Measure 9

Measure Type Primary
Measure Title 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
Measure Description Blood was collected from all participants prior to and at Day 21 post vaccination 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 Day 0 prior to and Day 21 following 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 the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. 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
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

Measured Values
   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 
Participants Analyzed 
[Units: Participants]
 26   28   28 
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 
[Units: Participants]
     
Day 0   5   3   2 
Day 21   22   27   26 

No statistical analysis provided for 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



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.


  More Information