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Novartis H1N1 Vaccine in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00992719
Recruitment Status : Completed
First Posted : October 9, 2009
Results First Posted : March 5, 2012
Last Update Posted : August 7, 2013
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: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Inactivated H1N1 Vaccine
Enrollment 84
Recruitment Details 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  
Arm/Group Title 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
Hide Arm/Group Description Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Period Title: Overall Study
Started 28 28 28
Completed 27 27 28
Not Completed 1 1 0
Arm/Group Title 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
Hide Arm/Group Description Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 28 28 28 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 28 participants 84 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
28
 100.0%
28
 100.0%
84
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 28 participants 84 participants
30  (6.0) 28.8  (4.9) 30.8  (5.6) 29.9  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 28 participants 84 participants
Female
28
 100.0%
28
 100.0%
28
 100.0%
84
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 28 participants 84 participants
28 28 28 84
1.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
Hide 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 Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 27 28
Measure Type: Number
Unit of Measure: 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
2.Primary Outcome
Title Number of Births With 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
Hide Outcome Measure Data
Hide Analysis Population Description
All births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.
Arm/Group Title Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 29 32
Measure Type: Number
Unit of Measure: 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
3.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 vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 28 28 28
Measure Type: Number
Unit of Measure: participants
0 0 0
4.Primary Outcome
Title Number of Participants Reporting Solicited Subjective Local Reactions After 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 post vaccination (Day 0-7)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 28 28 28
Measure Type: Number
Unit of Measure: participants
Pain 4 8 6
Tenderness 13 15 14
Swelling 1 2 2
5.Primary Outcome
Title Number of Participants Reporting Solicited Quantitative Local Reactions After 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 post vaccination (Day 0-7)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 28 28 28
Measure Type: Number
Unit of Measure: participants
Redness 2 2 2
Swelling 1 1 2
6.Primary Outcome
Title Number of Participants Reporting Solicited Subjective Systemic Reactions After 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 post vaccination (Day 0-7)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 28 28 28
Measure Type: Number
Unit of Measure: participants
Feverishness 0 2 3
Malaise 7 14 4
Myalgia 1 6 4
Headache 8 9 7
Nausea 3 8 3
7.Primary Outcome
Title Number of Participants Reporting Fever After 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 vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 28 27 28
Measure Type: Number
Unit of Measure: participants
1 0 0
8.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 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 26 28 28
Measure Type: Number
Unit of Measure: participants
18 26 24
9.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 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 26 28 28
Measure Type: Number
Unit of Measure: participants
Day 0 5 3 2
Day 21 22 27 26
10.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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 25 22
Measure Type: Number
Unit of Measure: participants
17 16
11.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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine
Hide Arm/Group Description:
Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
17 18
Time Frame Solicited events were collected for 8 days after vaccination, unsolicited events through 21 days after vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after vaccination, including at the time of delivery.
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 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
Hide Arm/Group Description Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/28 (28.57%)      6/28 (21.43%)      1/28 (3.57%)    
Congenital, familial and genetic disorders       
Pilonidal cyst congenital * 1  0/28 (0.00%)  0 1/28 (3.57%)  2 0/28 (0.00%)  0
Patent ductus arteriosus * 1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Hepatobiliary disorders       
Hyperbilirubinaemia * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations       
Sepsis * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Meningitis bacterial * 1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia * 1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid cancer * 1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Pregnancy, puerperium and perinatal conditions       
Premature labour * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Pre-eclampsia * 1  1/28 (3.57%)  1 3/28 (10.71%)  3 0/28 (0.00%)  0
Amniorrhoea * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Postpartum haemorrhage * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Premature separation of placenta * 1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Foetal distress syndrome * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Premature baby * 1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0
Renal and urinary disorders       
Renal colic * 1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0
Reproductive system and breast disorders       
Vaginal haemorrhage * 1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Respiratory distress * 1  2/28 (7.14%)  2 1/28 (3.57%)  1 0/28 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/28 (67.86%)      24/28 (85.71%)      19/28 (67.86%)    
Gastrointestinal disorders       
Nausea  1  3/28 (10.71%)  3 8/28 (28.57%)  8 3/28 (10.71%)  3
General disorders       
Feeling hot  1  0/28 (0.00%)  0 2/28 (7.14%)  2 3/28 (10.71%)  3
Malaise  1  7/28 (25.00%)  7 14/28 (50.00%)  14 4/28 (14.29%)  4
Injection site pain  1  4/28 (14.29%)  4 8/28 (28.57%)  8 6/28 (21.43%)  6
Tenderness  1 [1]  13/28 (46.43%)  13 15/28 (53.57%)  15 14/28 (50.00%)  14
Injection site erythema  1  2/28 (7.14%)  2 2/28 (7.14%)  2 2/28 (7.14%)  2
Injection site swelling (functional grading)  1 [2]  1/28 (3.57%)  1 2/28 (7.14%)  2 2/28 (7.14%)  2
Injection site swelling (measured)  1 [2]  1/28 (3.57%)  1 1/28 (3.57%)  1 2/28 (7.14%)  2
Infections and infestations       
Upper respiratory tract infection * 1  4/28 (14.29%)  4 0/28 (0.00%)  0 6/28 (21.43%)  6
Musculoskeletal and connective tissue disorders       
Myalgia  1  1/28 (3.57%)  1 6/28 (21.43%)  6 4/28 (14.29%)  4
Nervous system disorders       
Headache  1  8/28 (28.57%)  8 9/28 (32.14%)  9 7/28 (25.00%)  7
Psychiatric disorders       
Insomnia * 1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
[1]
Solicited as a reaction at the vaccination site
[2]
Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
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.
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
Layout table for Results Point of Contact information
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
EMail: geeta.swamy@duke.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00992719    
Other Study ID Numbers: 09-0072
N01AI80057C
First Submitted: October 8, 2009
First Posted: October 9, 2009
Results First Submitted: January 19, 2012
Results First Posted: March 5, 2012
Last Update Posted: August 7, 2013