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H1N1 Vaccine in Pregnant Women

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ClinicalTrials.gov Identifier: NCT00963430
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : May 16, 2011
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Inactivated H1N1 Vaccine
Enrollment 120
Recruitment Details 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  
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Period Title: Overall Study
Started 60 60
Completed 59 57
Not Completed 1 3
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine Total
Hide Arm/Group Description Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
60
 100.0%
120
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
31.7  (4.3) 31.2  (4.3) 31.4  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
60
 100.0%
60
 100.0%
120
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Participants
Pain 15 21
Tenderness 26 37
Swelling 1 1
2.Primary Outcome
Title Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 49 54
Measure Type: Number
Unit of Measure: Participants
Pain 10 20
Tenderness 26 37
Swelling 1 0
3.Primary Outcome
Title Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Participants
Redness 5 8
Swelling 4 1
4.Primary Outcome
Title Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 49 54
Measure Type: Number
Unit of Measure: Participants
Redness 2 3
Swelling 1 0
5.Primary Outcome
Title Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Participants
Feverishness 5 4
Malaise 19 24
Myalgia 12 8
Headache 17 18
Nausea 10 12
6.Primary Outcome
Title Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 49 54
Measure Type: Number
Unit of Measure: Participants
Feverishness 2 4
Malaise 8 14
Myalgia 3 6
Headache 11 11
Nausea 2 4
7.Primary Outcome
Title Number of Participants Reporting Fever After First Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Participants
0 1
8.Primary Outcome
Title Number of Participants Reporting Fever After Second Vaccination
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 49 54
Measure Type: Number
Unit of Measure: Participants
1 0
9.Primary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 55 58
Measure Type: Number
Unit of Measure: Participants
49 56
10.Primary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 55 58
Measure Type: Number
Unit of Measure: Participants
51 56
11.Primary Outcome
Title Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: 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
12.Primary Outcome
Title Number of Participants Reporting Neonatal Complications
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 61 62
Measure Type: Number
Unit of Measure: 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
13.Primary Outcome
Title Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the first vaccination are included in the ITT safety cohort.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Unit of Measure: Participants
0 0
14.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 41 47
Measure Type: Number
Unit of Measure: Participants
35 29
15.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 39 46
Measure Type: Number
Unit of Measure: Participants
34 41
16.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 38 51
Measure Type: Number
Unit of Measure: Participants
36 47
17.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Overall Number of Participants Analyzed 38 51
Measure Type: Number
Unit of Measure: Participants
36 47
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.
Adverse Event Reporting 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.
 
Arm/Group Title 15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Hide Arm/Group Description Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21. Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
All-Cause Mortality
15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/60 (15.00%)      6/60 (10.00%)    
Pregnancy, puerperium and perinatal conditions     
Postpartum haemorrhage * 1  4/60 (6.67%)  4 2/60 (3.33%)  2
Pre-eclampsia * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
Abortion spontaneous * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
Premature labour * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
Caesarean section * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
Threatened labour * 1  0/60 (0.00%)  0 2/60 (3.33%)  2
HELLP syndrome * 1  0/60 (0.00%)  0 1/60 (1.67%)  1
Retained placenta or membranes * 1  0/60 (0.00%)  0 1/60 (1.67%)  1
Pregnancy induced hypertension * 1  0/60 (0.00%)  0 1/60 (1.67%)  1
Reproductive system and breast disorders     
Vaginal haemorrhage * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
Surgical and medical procedures     
Myomectomy * 1  1/60 (1.67%)  1 0/60 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
15 Mcg H1N1 Vaccine 30 Mcg H1N1 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/60 (88.33%)      54/60 (90.00%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/60 (0.00%)  0 4/60 (6.67%)  4
Gastrointestinal disorders     
Dyspepsia * 1  0/60 (0.00%)  0 3/60 (5.00%)  4
Nausea  1  10/60 (16.67%)  12 14/60 (23.33%)  16
General disorders     
Feeling hot  1  7/60 (11.67%)  7 8/60 (13.33%)  8
Malaise  1  23/60 (38.33%)  27 28/60 (46.67%)  38
Injection site pain  1  21/60 (35.00%)  25 31/60 (51.67%)  41
Tenderness  1 [1]  37/60 (61.67%)  52 44/60 (73.33%)  74
Injection site erythema  1  6/60 (10.00%)  7 9/60 (15.00%)  11
Injection site swelling  1  5/60 (8.33%)  5 1/60 (1.67%)  1
Infections and infestations     
Upper respiratory tract infection * 1  8/60 (13.33%)  8 10/60 (16.67%)  11
Urinary tract infection * 1  2/60 (3.33%)  2 3/60 (5.00%)  3
Musculoskeletal and connective tissue disorders     
Back pain * 1  4/60 (6.67%)  4 3/60 (5.00%)  3
Myalgia  1  15/60 (25.00%)  15 11/60 (18.33%)  14
Nervous system disorders     
Headache  1  23/60 (38.33%)  28 24/60 (40.00%)  29
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  2/60 (3.33%)  2 3/60 (5.00%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
[1]
Tenderness was solicited as a reaction at the vaccination site.
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.
Results Point of Contact
Name/Title: Lisa Jackson, MD, MPH
Organization: Group Health Research Institute
Phone: 206-442-5216
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00963430     History of Changes
Other Study ID Numbers: 09-0056
N01AI80004C
First Submitted: August 20, 2009
First Posted: August 21, 2009
Results First Submitted: April 21, 2011
Results First Posted: May 16, 2011
Last Update Posted: December 3, 2012