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Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01181323
First received: August 12, 2010
Last updated: January 15, 2015
Last verified: April 2013
Results First Received: April 17, 2014  
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
Interventions: Other: Placebo
Biological: Cold-adapted live attenuated influenza virus vaccine, trivalent
Biological: Trivalent inactivated influenza 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 post-partum women recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 6Sep2011 and 31Oct2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Maternal participants and their infants were enrolled separately in the study for the purposes of data collection, analysis and reporting. For baseline measures, adverse events, and outcome measures as appropriate, the infants are defined as their own arms of the study based on the study product the mother received.

Reporting Groups
  Description
Maternal LAIV Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection
Maternal TIV Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
Infant LAIV Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
Infant TIV Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.

Participant Flow:   Overall Study
    Maternal LAIV   Maternal TIV   Infant LAIV   Infant TIV
STARTED   124   124   124   125 
COMPLETED   123   121   123   122 
NOT COMPLETED   1   3   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.
All enrolled subjects are included in the baseline analysis population.

Reporting Groups
  Description
Maternal LAIV Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
Maternal TIV Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
Infant LAIV Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
Infant TIV Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Total Total of all reporting groups

Baseline Measures
   Maternal LAIV   Maternal TIV   Infant LAIV   Infant TIV   Total 
Overall Participants Analyzed 
[Units: Participants]
 124   124   124   125   497 
Age 
[Units: Participants]
         
<=18 years   0   0   124   125   249 
Between 18 and 65 years   124   124   0   0   248 
>=65 years   0   0   0   0   0 
Gender 
[Units: Participants]
         
Female   124   124   61   62   371 
Male   0   0   63   63   126 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   5   5   2   3   15 
Native Hawaiian or Other Pacific Islander   1   1   0   1   3 
Black or African American   13   11   10   11   45 
White   98   98   95   93   384 
More than one race   6   9   17   17   49 
Unknown or Not Reported   1   0   0   0   1 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   6   1   10   6   23 
Not Hispanic or Latino   118   123   114   119   474 
Unknown or Not Reported   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
         
United States   124   124   124   125   497 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Serious Adverse Events (SAEs)   [ Time Frame: Day 0 to Day 180 post vaccination ]

2.  Primary:   Number of Participants Reporting New Onset Chronic Medical Conditions   [ Time Frame: Day 0 to Day 180 post vaccination ]

3.  Primary:   Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination   [ Time Frame: Day 0 to Day 10 post vaccination ]

4.  Primary:   Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination   [ Time Frame: Day 0 to Day 28 post vaccination ]

5.  Primary:   Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains   [ Time Frame: Day 0 and 28 post vaccination ]

6.  Primary:   Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination   [ Time Frame: Within 28-42 days after maternal vaccination ]

7.  Primary:   Number of Maternal Participants Reporting Fever After Vaccination   [ Time Frame: Day 0-7 post vaccination ]

8.  Primary:   Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination   [ Time Frame: Day 0-7 post vaccination ]

9.  Primary:   Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination   [ Time Frame: Day 0-7 post vaccination ]

10.  Primary:   Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination   [ Time Frame: Day 0-7 post vaccination ]

11.  Secondary:   Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received   [ Time Frame: Day 0 and 28 post vaccination ]

12.  Secondary:   Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.   [ Time Frame: Day 0 prior to vaccination ]

13.  Secondary:   Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.   [ Time Frame: Day 2 post vaccination ]

14.  Secondary:   Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.   [ Time Frame: Day 8 post vaccination ]

15.  Secondary:   Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.   [ Time Frame: Day 0 prior to vaccination ]

16.  Secondary:   Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.   [ Time Frame: Day 2 post vaccination ]

17.  Secondary:   Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.   [ Time Frame: Day 8 post vaccination ]

18.  Secondary:   Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 0 Who Were Positive for H1N1 and/or H3N2 Strains.   [ Time Frame: Day 0 prior to vaccination ]

19.  Secondary:   Number of Maternal and Infant Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 2 Who Were Positive for H1N1 and/or H3N2 Strains.   [ Time Frame: Day 2 post vaccination ]

20.  Secondary:   Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 8 Who Were Positive for H1N1 and/or H3N2 Strains.   [ Time Frame: Day 8 post vaccination ]

21.  Secondary:   Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination.   [ Time Frame: Day 2 and 8 post vaccination ]

22.  Secondary:   ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects   [ Time Frame: Day 0 and Day 28 post vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Steinhoff, MD
Organization: Cincinnati Children’s Hospital Medical Center
phone: 513-636-2791
e-mail: Mark.steinhoff@cchmc.org



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01181323     History of Changes
Other Study ID Numbers: 09-0007
HHSN272200800006C
Study First Received: August 12, 2010
Results First Received: April 17, 2014
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government