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
  Hide 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 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
  Hide 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
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 ]

Measure Type Primary
Measure Title Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Measure Description Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. 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 participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.

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

Measured Values
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  27     28  
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery  
[units: participants]
   
Stillborn     0     0  
Miscarriage     0     0  
Gestational diabetes     1     2  
Polyhydramnios     1     0  
Oligohydramnios     1     1  
Pregnancy induced hypertension     0     3  
Pre-eclampsia     1     3  
Eclampsia     0     0  
Fetal Distress     2     1  
Abruptio Placenta     0     1  
Chorioamnionitis     0     0  
Fever     2     1  
Anaphylaxis     0     0  
Antibiotics prior to delivery     12     12  
Fetal abnormalities detected during pregnancy     1     0  
Assisted vaginal delivery     1     1  
Non-elective Cesarean section     6     3  
Abnormal amniotic fluid     5     5  
Postpartum fever     0     0  
Postpartum endometritis     0     0  
Postpartum bleeding     2     0  
Postpartum bacteremia     0     0  

No statistical analysis provided for Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery



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

Measure Type Primary
Measure Title Number of Births With 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 births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.

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

Measured Values
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  29     32  
Number of Births With Neonatal Complications  
[units: births]
   
Pre-term (less than 37 weeks)     5     9  
Large for gestational age     6     2  
Small for gestational age     0     3  
Abnormal infant exam     1     4  
Congenital abnormalities     0     1  
Hematological complications     1     1  
Infections     0     0  
Sepsis     0     0  
Meningitis     0     0  
Metabolic complications     1     1  
Respiratory complications     5     4  
Respiratory support used     5     4  
Fever 100.4 degrees Fahrenheit or greater     0     0  
Admission to special nursery/infant intensive care     5     8  

No statistical analysis provided for Number of Births With Neonatal Complications



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

Measure Type Primary
Measure Title Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Measure Description Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.
Time Frame Day 0 through Day 180 after vaccination  
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 participants receiving the vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  28     28     28  
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)  
[units: participants]
  0     0     0  

No statistical analysis provided for Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days post vaccination (Day 0-7)  
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 participants receiving the vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  28     28     28  
Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination  
[units: participants]
     
Pain     4     8     6  
Tenderness     13     15     14  
Swelling     1     2     2  

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame Within 8 days post vaccination (Day 0-7)  
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 participants receiving the vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  28     28     28  
Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination  
[units: participants]
     
Redness     2     2     2  
Swelling     1     1     2  

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days post vaccination (Day 0-7)  
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 participants receiving the vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  28     28     28  
Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination  
[units: participants]
     
Feverishness     0     2     3  
Malaise     7     14     4  
Myalgia     1     6     4  
Headache     8     9     7  
Nausea     3     8     3  

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination



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

Measure Type Primary
Measure Title Number of Participants Reporting Fever After Vaccination
Measure Description Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post vaccination  
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 participants receiving the vaccination and who reported temperatures are included in the safety cohort. One participant did not report temperatures. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  28     27     28  
Number of Participants Reporting Fever After Vaccination  
[units: participants]
  1     0     0  

No statistical analysis provided for Number of Participants Reporting Fever After 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 ]

Measure Type Primary
Measure Title 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
Measure Description Blood was collected from all participants prior to vaccination as well as 21 days after 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 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 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to and Day 21 after the first vaccination  
Safety Issue No  

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  
Number of Participants Analyzed  
[units: participants]
  26     28     28  
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  
[units: participants]
  18     26     24  

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 a Single Dose of H1N1 Vaccine



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 ]

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  
Safety Issue No  

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  
Number of 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 ]

Measure Type Secondary
Measure Title 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
Measure Description Blood was collected from participants at the time of delivery 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 At time of delivery  
Safety Issue No  

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.
Pregnant participants were included in the analyses if they had blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. 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

Measured Values
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  25     22  
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  
[units: participants]
  17     16  

No statistical analysis provided for 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



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 ]

Measure Type Secondary
Measure Title 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
Measure Description Cord blood was collected at the time of delivery 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 At time of delivery  
Safety Issue No  

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.
Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. 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

Measured Values
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  22     22  
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  
[units: participants]
  17     18  

No statistical analysis provided for 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




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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
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.  


Results Point of Contact:  
Name/Title: Geeta K. Swamy, M.D.
Organization: Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine, Duke University School of Medicine
phone: 919-681-5220
e-mail: geeta.swamy@duke.edu


No publications provided


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00992719     History of Changes
Other Study ID Numbers: 09-0072, N01AI80057C
Study First Received: October 8, 2009
Results First Received: January 19, 2012
Last Updated: August 1, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration