Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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
  Hide 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 ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After First 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 (Day 0-7) post first 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 first vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  60     60  
Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination  
[units: Participants]
   
Pain     15     21  
Tenderness     26     37  
Swelling     1     1  

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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After Second 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 (Day 0-7) post second 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 second vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  49     54  
Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination  
[units: Participants]
   
Pain     10     20  
Tenderness     26     37  
Swelling     1     0  

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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After First 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 (Day 0-7) post first 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 first vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  60     60  
Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination  
[units: Participants]
   
Redness     5     8  
Swelling     4     1  

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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After Second 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 (Day 0-7) post second 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 second vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  49     54  
Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination  
[units: Participants]
   
Redness     2     3  
Swelling     1     0  

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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Systemic Reactions After First 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 (Day 0-7) post first 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 first vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  60     60  
Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination  
[units: Participants]
   
Feverishness     5     4  
Malaise     19     24  
Myalgia     12     8  
Headache     17     18  
Nausea     10     12  

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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Systemic Reactions After Second 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 (Day 0-7) post second 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 second vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  49     54  
Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination  
[units: Participants]
   
Feverishness     2     4  
Malaise     8     14  
Myalgia     3     6  
Headache     11     11  
Nausea     2     4  

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Fever After First 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 first 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 first vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  60     60  
Number of Participants Reporting Fever After First Vaccination  
[units: Participants]
  0     1  

No statistical analysis provided for Number of Participants Reporting Fever After First Vaccination



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

Measure Type Primary
Measure Title Number of Participants Reporting Fever After Second 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 second 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 second vaccination are included in the safety cohort. Analyses are 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  
Number of Participants Analyzed  
[units: participants]
  49     54  
Number of Participants Reporting Fever After Second Vaccination  
[units: Participants]
  1     0  

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

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 the initial vaccination as well as 21 days after the first 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 first vaccination and had blood collected at both timepoints, with 5 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  
Number of Participants Analyzed  
[units: participants]
  55     58  
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]
  49     56  

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



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 ]

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 at Day 21 post first 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 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 first vaccination and had blood collected at the timepoint, with 5 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  
Number of Participants Analyzed  
[units: participants]
  55     58  
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]
  51     56  

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



11.  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
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  
Number of Participants Analyzed  
[units: participants]
  60     60  
Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery  
[units: Participants]
   
Stillborn     1     0  
Miscarriage     1     0  
Gestational diabetes     1     4  
Polyhydramnios     1     0  
Oligohydramnios     2     2  
Pregnancy induced hypertension     0     3  
Pre-eclampsia     1     2  
Eclampsia     0     0  
Fetal Distress     1     3  
Abruptio Placenta     1     0  
Chorioamnionitis     3     2  
Fever     2     2  
Anaphylaxis     0     0  
Antibiotics prior to delivery     26     20  
Fetal abnormalities detected during pregnancy     3     5  
Assisted vaginal delivery     4     3  
Non-elective Cesarean section     4     4  
Abnormal amniotic fluid     11     12  
Postpartum fever     1     0  
Postpartum endometritis     0     0  
Postpartum bleeding     5     5  
Postpartum bacteremia     0     0  

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



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

Measure Type Primary
Measure Title Number of Participants Reporting 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 live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, each counted separately.

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  
Number of Participants Analyzed  
[units: participants]
  61     62  
Number of Participants Reporting Neonatal Complications  
[units: Participants]
   
Pre-term (less than 37 weeks)     10     7  
Large for gestational age     12     3  
Small for gestational age     3     1  
Abnormal infant exam     15     13  
Congenital abnormalities     1     3  
Hematological complications     3     1  
Infection     0     0  
Sepsis     0     0  
Meningitis     0     0  
Metabolic complications     4     0  
Respiratory complications     6     3  
Respiratory support used     5     3  
Fever 100.4 degrees Fahrenheit or greater     0     0  
Admission to special nursery/infant intensive care     6     6  

No statistical analysis provided for Number of Participants Reporting Neonatal Complications



13.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after last 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 last 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 first vaccination are included in the ITT safety cohort.

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  
Number of Participants Analyzed  
[units: participants]
  60     60  
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)  
[units: Participants]
  0     0  

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



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 ]

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.
Participants were included in the analyses if they had blood collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 3 due to specimen processing errors at the time of sample collection. 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  
Number of Participants Analyzed  
[units: participants]
  41     47  
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]
  35     29  

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



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 ]

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.
Participants were included in the analyses if a cord blood sample was collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 5 due to specimen processing errors at the time of sample collection.

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  
Number of Participants Analyzed  
[units: participants]
  39     46  
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]
  34     41  

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



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 ]

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  
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 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  
Number of Participants Analyzed  
[units: participants]
  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 ]

Measure Type Secondary
Measure Title 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
Measure Description Blood was collected from all participants at Day 21 post second 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 21 after the second 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 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  
Number of Participants Analyzed  
[units: participants]
  38     51  
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  
[units: Participants]
  36     47  

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 2 Doses of H1N1 Vaccine




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