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: May 22, 2014
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: Drug: Placebo (IN)
Biological: Fluzone®
Biological: Flumist®
Drug: Placebo (IM)

  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  
Number of Participants  
[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
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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:   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 ]

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

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

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

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

10.  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 ]

11.  Primary:   Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains   [ Time Frame: Day 28 post vaccination ]
Results not yet posted.   Anticipated Posting Date:   08/2014   Safety Issue:   No

12.  Secondary:   Number of Participants With LAIV Virus Strains in the Vaccine Received Detected in Respiratory Secretions.   [ Time Frame: Day 2 and 8 post vaccination ]
Results not yet posted.   Anticipated Posting Date:   08/2014   Safety Issue:   No

13.  Secondary:   Number of Participants With LAIV Virus Strains in the Vaccine Received Detected in Their Breast Milk.   [ Time Frame: Day 2 and 8 post vaccination ]
Results not yet posted.   Anticipated Posting Date:   08/2014   Safety Issue:   No

14.  Secondary:   ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects   [ Time Frame: Days 0 and 28 post vaccination ]
Results not yet posted.   Anticipated Posting Date:   08/2014   Safety Issue:   Yes


  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


No publications provided


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01181323     History of Changes
Other Study ID Numbers: 09-0007, N01AI80006C
Study First Received: August 12, 2010
Results First Received: April 17, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government