Novartis H1N1 Vaccine in Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992719
First received: October 8, 2009
Last updated: August 1, 2013
Last verified: July 2010
Results First Received: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Inactivated H1N1 Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were healthy pregnant and non-pregnant women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09Nov2009 and 04May2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0

Participant Flow:   Overall Study
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine     Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine  
STARTED     28     28     28  
COMPLETED     27     27     28  
NOT COMPLETED     1     1     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Total Total of all reporting groups

Baseline Measures
    Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine     Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine     Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine     Total  
Number of Participants  
[units: participants]
  28     28     28     84  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     28     28     28     84  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30  ± 6.0     28.8  ± 4.9     30.8  ± 5.6     29.9  ± 5.5  
Gender  
[units: participants]
       
Female     28     28     28     84  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     28     28     28     84  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery   [ Time Frame: At time of delivery ]

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

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

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

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

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

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

8.  Primary:   Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 21 after the first vaccination ]

9.  Primary:   Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 21 following vaccination ]

10.  Secondary:   Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery   [ Time Frame: At time of delivery ]

11.  Secondary:   Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood   [ Time Frame: At time of delivery ]


  Serious Adverse Events


  Other Adverse Events
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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.
Additional 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.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0

Other 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  
Total, other (not including serious) adverse events        
# participants affected / at risk     19/28     24/28     19/28  
Gastrointestinal disorders        
Nausea † 1      
# participants affected / at risk     3/28 (10.71%)     8/28 (28.57%)     3/28 (10.71%)  
# events     3     8     3  
General disorders        
Feeling hot † 1      
# participants affected / at risk     0/28 (0.00%)     2/28 (7.14%)     3/28 (10.71%)  
# events     0     2     3  
Malaise † 1      
# participants affected / at risk     7/28 (25.00%)     14/28 (50.00%)     4/28 (14.29%)  
# events     7     14     4  
Injection site pain † 1      
# participants affected / at risk     4/28 (14.29%)     8/28 (28.57%)     6/28 (21.43%)  
# events     4     8     6  
Tenderness † 1 [4]      
# participants affected / at risk     13/28 (46.43%)     15/28 (53.57%)     14/28 (50.00%)  
# events     13     15     14  
Injection site erythema † 1      
# participants affected / at risk     2/28 (7.14%)     2/28 (7.14%)     2/28 (7.14%)  
# events     2     2     2  
Injection site swelling (functional grading) † 1 [5]      
# participants affected / at risk     1/28 (3.57%)     2/28 (7.14%)     2/28 (7.14%)  
# events     1     2     2  
Injection site swelling (measured) † 1 [5]      
# participants affected / at risk     1/28 (3.57%)     1/28 (3.57%)     2/28 (7.14%)  
# events     1     1     2  
Infections and infestations        
Upper respiratory tract infection * 1      
# participants affected / at risk     4/28 (14.29%)     0/28 (0.00%)     6/28 (21.43%)  
# events     4     0     6  
Musculoskeletal and connective tissue disorders        
Myalgia † 1      
# participants affected / at risk     1/28 (3.57%)     6/28 (21.43%)     4/28 (14.29%)  
# events     1     6     4  
Nervous system disorders        
Headache † 1      
# participants affected / at risk     8/28 (28.57%)     9/28 (32.14%)     7/28 (25.00%)  
# events     8     9     7  
Psychiatric disorders        
Insomnia * 1      
# participants affected / at risk     0/28 (0.00%)     2/28 (7.14%)     0/28 (0.00%)  
# events     0     2     0  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (14.0)
[4] Solicited as a reaction at the vaccination site
[5] Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Although 200 pregnant and 100 non-pregnant subjects were targeted for enrollment, enrollment closed in May 2010 prior to reaching the target due to slow accrual.


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