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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;   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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
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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.

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

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
Total, Serious Adverse Events       
# participants affected / at risk   8/28 (28.57%)   6/28 (21.43%)   1/28 (3.57%) 
Congenital, familial and genetic disorders       
Pilonidal cyst congenital * 1       
# participants affected / at risk   0/28 (0.00%)   1/28 (3.57%)   0/28 (0.00%) 
# events   0   2   0 
Patent ductus arteriosus * 1       
# participants affected / at risk   0/28 (0.00%)   1/28 (3.57%)   0/28 (0.00%) 
# events   0   1   0 
Hepatobiliary disorders       
Hyperbilirubinaemia * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Infections and infestations       
Sepsis * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Meningitis bacterial * 1       
# participants affected / at risk   0/28 (0.00%)   1/28 (3.57%)   0/28 (0.00%) 
# events   0   1   0 
Metabolism and nutrition disorders       
Hypoglycaemia * 1       
# participants affected / at risk   0/28 (0.00%)   1/28 (3.57%)   0/28 (0.00%) 
# events   0   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid cancer * 1       
# participants affected / at risk   0/28 (0.00%)   0/28 (0.00%)   1/28 (3.57%) 
# events   0   0   1 
Pregnancy, puerperium and perinatal conditions       
Premature labour * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Pre-eclampsia * 1       
# participants affected / at risk   1/28 (3.57%)   3/28 (10.71%)   0/28 (0.00%) 
# events   1   3   0 
Amniorrhoea * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Postpartum haemorrhage * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Premature separation of placenta * 1       
# participants affected / at risk   0/28 (0.00%)   1/28 (3.57%)   0/28 (0.00%) 
# events   0   1   0 
Foetal distress syndrome * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Premature baby * 1       
# participants affected / at risk   0/28 (0.00%)   2/28 (7.14%)   0/28 (0.00%) 
# events   0   2   0 
Renal and urinary disorders       
Renal colic * 1       
# participants affected / at risk   0/28 (0.00%)   1/28 (3.57%)   0/28 (0.00%) 
# events   0   1   0 
Reproductive system and breast disorders       
Vaginal haemorrhage * 1       
# participants affected / at risk   1/28 (3.57%)   0/28 (0.00%)   0/28 (0.00%) 
# events   1   0   0 
Respiratory, thoracic and mediastinal disorders       
Respiratory distress * 1       
# participants affected / at risk   2/28 (7.14%)   1/28 (3.57%)   0/28 (0.00%) 
# events   2   1   0 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (14.0)




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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


  More Information