Trial Outcomes & Findings for Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women (NCT NCT01181323)

Results Overview

Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

240 participants

Primary outcome timeframe

Day 0 to Day 180 post vaccination

Results posted on

2015-01-28

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	124	124	124	125
Overall Study COMPLETED	123	121	123	122
Overall Study NOT COMPLETED	1	3	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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 n=124 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=125 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.	Total n=497 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	124 Participants n=5 Participants	125 Participants n=4 Participants	249 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	124 Participants n=5 Participants	124 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	248 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	124 Participants n=7 Participants	61 Participants n=5 Participants	62 Participants n=4 Participants	371 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	63 Participants n=5 Participants	63 Participants n=4 Participants	126 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	45 Participants n=21 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	98 Participants n=7 Participants	95 Participants n=5 Participants	93 Participants n=4 Participants	384 Participants n=21 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	49 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=5 Participants	123 Participants n=7 Participants	114 Participants n=5 Participants	119 Participants n=4 Participants	474 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	124 participants n=5 Participants	124 participants n=7 Participants	124 participants n=5 Participants	125 participants n=4 Participants	497 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 180 post vaccination

Population: All enrolled participants are included in the analysis population for this outcome measure.

Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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 n=124 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=125 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Participants Reporting Serious Adverse Events (SAEs)	1 participants	0 participants	2 participants	1 participants

PRIMARY outcome

Timeframe: Day 0 to Day 180 post vaccination

Population: All enrolled participants are included in the analysis population for this outcome measure.

New onset chronic medical condition was defined as any new ICD-10 diagnosis for a participant that was expected to continue for at least 6 months and require continued health care intervention. ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th revision. Maternal participants were asked at each visit through 180 days after enrollment if they or their infants had any new diagnosis.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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 n=124 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=125 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Participants Reporting New Onset Chronic Medical Conditions	1 participants	1 participants	3 participants	4 participants

PRIMARY outcome

Timeframe: Day 0 to Day 10 post vaccination

Maternal participants maintained a memory aid to record daily the occurrence in their infants of systemic adverse events of fever (defined as rectal temperature 37.8 degrees Celsius or greater), drowsiness, irritability/fussiness, loss of appetite, nasal congestion, difficulty breathing, runny nose, and cough for 11 days (Day 0-10) after maternal vaccination based on protocol-defined grading (none, mild, moderate or severe) for each symptom. Rectal temperature was measured once daily. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 11 days.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=125 Participants 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.
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Fever	28 participants	23 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Drowsiness	42 participants	33 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Irritability/fussiness	74 participants	56 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Loss of appetite	20 participants	14 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Nasal congestion	54 participants	54 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Difficulty breathing	12 participants	7 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Runny nose	18 participants	30 participants	—	—
Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination Cough	15 participants	18 participants	—	—

PRIMARY outcome

Timeframe: Day 0 to Day 28 post vaccination

Population: All enrolled participants are included in the analysis population for this outcome measure

Adverse events (AE) for this protocol used the International Conference on Harmonization (ICH) guideline E6 definition of AE, any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product. Related was defined as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. Non-serious AEs were those that did not meet the definition of serious (see Outcome Measure 1). Maternal participants were queried at each visit through 28 days after vaccination for the occurrence of any AE for her or the infant separately from the pre-defined solicited symptoms.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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 n=124 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=125 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination	6 participants	3 participants	5 participants	8 participants

PRIMARY outcome

Timeframe: Day 0 and 28 post vaccination

Population: All enrolled maternal participants are included in this analysis population.

Breast milk was collected at Day 0 prior to vaccination and again at 28 days following vaccination for testing in IgA and IgG ELISA Assays. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=76 Participants 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 n=48 Participants 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 n=74 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=50 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgA to A/California/7/2009 (H1N1)	8.8 units/mL Interval 6.6 to 11.7	8.6 units/mL Interval 6.1 to 12.2	8.7 units/mL Interval 6.3 to 12.0	7.5 units/mL Interval 5.1 to 11.0
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgA to A/California/7/2009 (H1N1)	9.0 units/mL Interval 6.6 to 12.4	10.5 units/mL Interval 7.5 to 14.7	23.2 units/mL Interval 15.2 to 35.4	10.8 units/mL Interval 7.4 to 15.8
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgA to A/Perth/16/2009 (H3N2)	22.9 units/mL Interval 17.1 to 30.6	32.8 units/mL Interval 24.4 to 44.2	20.9 units/mL Interval 15.5 to 28.1	23.8 units/mL Interval 15.7 to 36.0
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgA to A/Perth/16/2009 (H3N2)	29.3 units/mL Interval 21.3 to 40.2	50.8 units/mL Interval 37.1 to 69.4	44.2 units/mL Interval 31.6 to 61.8	38.9 units/mL Interval 25.0 to 60.4
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgA to A/Victoria/361/2011 (H3N2)	22.5 units/mL Interval 16.7 to 30.4	33.9 units/mL Interval 23.6 to 48.7	22.7 units/mL Interval 16.8 to 30.7	24.7 units/mL Interval 16.6 to 36.7
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgA to A/Victoria/361/2011 (H3N2)	28.5 units/mL Interval 20.7 to 39.1	51.8 units/mL Interval 37.9 to 70.9	46.0 units/mL Interval 32.7 to 64.5	44.2 units/mL Interval 28.3 to 69.0
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgA to B/Brisbane/60/2008	17.1 units/mL Interval 13.4 to 21.8	15.9 units/mL Interval 11.1 to 22.7	12.9 units/mL Interval 9.8 to 16.8	15.1 units/mL Interval 10.9 to 20.8
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgA to B/Brisbane/60/2008	22.9 units/mL Interval 17.2 to 30.3	22.0 units/mL Interval 15.0 to 32.3	23.9 units/mL Interval 17.4 to 32.8	23.4 units/mL Interval 16.5 to 33.4
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgA to B/Wisconsin/1/2010	8.2 units/mL Interval 6.4 to 10.6	10.0 units/mL Interval 7.1 to 14.1	8.3 units/mL Interval 6.3 to 10.8	7.5 units/mL Interval 5.6 to 10.1
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgA to B/Wisconsin/1/2010	10.6 units/mL Interval 7.9 to 14.1	15.3 units/mL Interval 9.9 to 23.5	10.7 units/mL Interval 7.9 to 14.6	21.2 units/mL Interval 13.6 to 33.1
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgG to A/California/7/2009 (H1N1)	1.6 units/mL Interval 1.4 to 1.8	1.6 units/mL Interval 1.3 to 1.9	1.7 units/mL Interval 1.5 to 2.0	1.7 units/mL Interval 1.4 to 2.1
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgG to A/California/7/2009 (H1N1)	1.6 units/mL Interval 1.4 to 1.8	1.6 units/mL Interval 1.4 to 1.9	5.0 units/mL Interval 3.7 to 6.7	2.9 units/mL Interval 2.2 to 3.9
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgG to A/Perth/16/2009 (H3N2)	2.4 units/mL Interval 2.0 to 2.9	2.6 units/mL Interval 2.1 to 3.4	2.1 units/mL Interval 1.7 to 2.5	2.7 units/mL Interval 2.0 to 3.5
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgG to A/Perth/16/2009 (H3N2)	2.3 units/mL Interval 1.9 to 2.9	2.9 units/mL Interval 2.3 to 3.8	5.5 units/mL Interval 4.3 to 7.2	6.7 units/mL Interval 5.0 to 8.9
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgG to A/Victoria/361/2011 (H3N2)	2.6 units/mL Interval 2.1 to 3.3	2.9 units/mL Interval 2.3 to 3.8	2.3 units/mL Interval 1.9 to 2.8	2.7 units/mL Interval 2.0 to 3.6
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgG to A/Victoria/361/2011 (H3N2)	2.9 units/mL Interval 2.3 to 3.6	3.5 units/mL Interval 2.6 to 4.5	6.0 units/mL Interval 4.5 to 7.8	7.7 units/mL Interval 5.7 to 10.4
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgG to B/Brisbane/60/2008	2.6 units/mL Interval 2.0 to 3.2	2.6 units/mL Interval 2.0 to 3.5	2.1 units/mL Interval 1.8 to 2.4	2.4 units/mL Interval 1.9 to 3.0
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgG to B/Brisbane/60/2008	2.7 units/mL Interval 2.2 to 3.4	2.9 units/mL Interval 2.2 to 3.8	4.9 units/mL Interval 3.7 to 6.3	4.2 units/mL Interval 3.2 to 5.6
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 0 IgG to B/Wisconsin/1/2010	1.7 units/mL Interval 1.4 to 1.9	1.6 units/mL Interval 1.3 to 1.8	1.5 units/mL Interval 1.3 to 1.6	1.6 units/mL Interval 1.3 to 1.9
Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains Day 28 IgG to B/Wisconsin/1/2010	1.6 units/mL Interval 1.4 to 1.9	1.6 units/mL Interval 1.4 to 1.9	1.9 units/mL Interval 1.6 to 2.2	5.0 units/mL Interval 3.4 to 7.2

PRIMARY outcome

Timeframe: Within 28-42 days after maternal vaccination

Population: All infant participants for whom the maternal participants were contacted are included in the analysis population description. One maternal participant was not contacted.

Maternal participants were contacted by telephone at Day 42 to report all medically attended respiratory or gastrointestinal adverse events occurring in the infant participants between 28 and 42 days after maternal vaccination.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=125 Participants 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.
Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination Respiratory AE	7 participants	5 participants	—	—
Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination Gastrointestinal AE	2 participants	0 participants	—	—

PRIMARY outcome

Timeframe: Day 0-7 post vaccination

Population: All enrolled maternal participants are included in this analysis population.

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.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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.
Number of Maternal Participants Reporting Fever After Vaccination	2 participants	1 participants	—	—

PRIMARY outcome

Timeframe: Day 0-7 post vaccination

Population: All enrolled maternal participants are included in this analysis population.

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, weakness, and chills 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.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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.
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Feverishness	7 participants	6 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Malaise	45 participants	38 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Myalgia	14 participants	23 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Headache	53 participants	48 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Nausea	5 participants	9 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Weakness	3 participants	3 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination Chills	3 participants	3 participants	—	—

PRIMARY outcome

Timeframe: Day 0-7 post vaccination

Population: All enrolled maternal participants are included in this analysis population.

Participants maintained a memory aid to record daily the occurrence of local symptoms of nasal congestion, runny nose, cough, sore throat, nasal bleeding, pain at injection site, tenderness at injection site, and swelling at injection site 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.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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.
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Cough	7 participants	8 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Nasal congestion	56 participants	26 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Runny nose	51 participants	38 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Sore throat	39 participants	32 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Nasal bleeding	3 participants	1 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Pain at Injection Site	9 participants	70 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Tenderness at injection site	17 participants	100 participants	—	—
Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination Swelling at injection site	6 participants	18 participants	—	—

PRIMARY outcome

Timeframe: Day 0-7 post vaccination

Population: All enrolled maternal participants are included in this analysis population.

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.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=124 Participants 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 n=124 Participants 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.
Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination Redness	13 participants	23 participants	—	—
Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination Swelling	6 participants	17 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and 28 post vaccination

Population: All enrolled maternal participants with results reported are included in this analysis population.

Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection for the assay was a titer of 10, sera samples below detection were given a value of 5 for analysis.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=75 Participants 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 n=48 Participants 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 n=74 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=50 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 28 - B/Wisconsin/1/2010	10.9 titer Interval 8.9 to 13.4	9.0 titer Interval 7.4 to 10.9	15.8 titer Interval 12.6 to 19.9	41.1 titer Interval 30.2 to 56.1
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 0 -A/California/7/2009 (H1N1)	44.7 titer Interval 31.9 to 62.6	44.6 titer Interval 31.6 to 63.0	42.9 titer Interval 30.1 to 61.1	64.1 titer Interval 43.1 to 95.3
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 28 - A/California/7/2009 (H1N1)	46.8 titer Interval 33.6 to 65.1	44.9 titer Interval 31.8 to 63.4	382.3 titer Interval 284.3 to 514.2	197.0 titer Interval 146.1 to 265.7
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 0 - A/Perth/16/2009 (H3N2)	45.5 titer Interval 32.6 to 63.5	53.0 titer Interval 36.1 to 77.8	32.9 titer Interval 23.5 to 46.0	52.1 titer Interval 37.7 to 71.9
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 28 - A/Perth/16/2009 (H3N2)	51.6 titer Interval 37.2 to 71.5	59.9 titer Interval 41.6 to 86.2	119.7 titer Interval 88.2 to 162.4	133.6 titer Interval 103.7 to 172.2
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 0 - B/Brisbane/60/2008	20.2 titer Interval 16.2 to 25.1	18.2 titer Interval 14.2 to 23.4	15.7 titer Interval 12.8 to 19.2	17.5 titer Interval 14.1 to 21.8
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 28 - B/Brisbane/60/2008	21.6 titer Interval 17.4 to 26.9	18.5 titer Interval 14.3 to 23.8	42.3 titer Interval 33.1 to 54.1	31.0 titer Interval 25.2 to 38.0
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 0 - A/Victoria/361/2011	47.0 titer Interval 33.2 to 66.6	60.4 titer Interval 42.5 to 85.7	38.0 titer Interval 26.6 to 54.2	62.8 titer Interval 43.7 to 90.2
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 28 - A/Victoria/361/2011	56.3 titer Interval 39.7 to 79.8	81.2 titer Interval 60.1 to 109.6	207.0 titer Interval 161.1 to 265.9	247.6 titer Interval 194.2 to 315.6
Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received Day 0 - B/Wisconsin/1/2010	10.3 titer Interval 8.4 to 12.7	8.7 titer Interval 7.0 to 10.7	9.1 titer Interval 7.6 to 11.0	10.6 titer Interval 8.6 to 13.1

SECONDARY outcome

Timeframe: Day 0 prior to vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=72 Participants 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 n=48 Participants 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 n=16 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=12 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR negative, cell culture negative	72 participants	47 participants	16 participants	12 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR positive, cell culture negative	0 participants	1 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR negative, cell culture negative	72 participants	48 participants	16 participants	12 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 2 post vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Nasal swab samples were collected from all maternal participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=73 Participants 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 n=47 Participants 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 n=19 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=12 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR negative, cell culture negative	51 participants	41 participants	19 participants	12 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR negative, cell culture positive	1 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR positive, cell culture negative	16 participants	6 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR positive, cell culture positive	5 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR negative, cell culture negative	39 participants	30 participants	19 participants	12 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR positive, cell culture negative	21 participants	13 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR positive, cell culture positive	13 participants	4 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 8 post vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=72 Participants 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 n=47 Participants 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 n=19 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=12 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR negative, cell culture negative	71 participants	47 participants	19 participants	12 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR positive, cell culture negative	1 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR negative, cell culture negative	65 participants	43 participants	19 participants	13 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR positive, cell culture negative	6 participants	2 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR positive, cell culture positive	1 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Nasal swab samples were collected from all infant participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=71 Participants 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 n=48 Participants 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 n=19 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=13 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR negative, cell culture negative	71 participants	48 participants	19 participants	13 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza A - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR negative, cell culture negative	71 participants	48 participants	19 participants	13 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination. Influenza B - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 2 post vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Nasal swab samples were collected from all infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=72 Participants 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 n=44 Participants 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 n=20 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=12 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR negative, cell culture negative	71 participants	44 participants	20 participants	12 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza A - PCR positive, cell culture positive	1 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR negative, cell culture negative	72 participants	44 participants	20 participants	12 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination. Influenza B - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 8 post vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Nasal swab samples were collected from all infant participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=72 Participants 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 n=47 Participants 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 n=19 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=13 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR negative, cell culture negative	72 participants	47 participants	19 participants	13 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR negative, cell culture negative	72 participants	47 participants	19 participants	13 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR negative, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza B - PCR positive, cell culture positive	0 participants	0 participants	0 participants	0 participants
Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination. Influenza A - PCR positive, cell culture negative	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination

Population: The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.

Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=1 Participants 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.
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. H1N1 - PCR negative, cell culture negative	1 participants	—	—	—
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. H1N1 - PCR negative, cell culture positive	0 participants	—	—	—
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. H1N1 - PCR positive, cell culture negative	0 participants	—	—	—
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. H1N1 - PCR positive, cell culture positive	0 participants	—	—	—
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. H3N2 - PCR negative, cell culture negative	1 participants	—	—	—
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. H3N2 - PCR negative, cell culture positive	0 participants	—	—	—
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. H3N2 - PCR positive, cell culture negative	0 participants	—	—	—
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. H3N2 - PCR positive, cell culture positive	0 participants	—	—	—

SECONDARY outcome

Timeframe: Day 2 post vaccination

Population: The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.

Nasal swab samples were collected from all maternal and infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=21 Participants 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 n=6 Participants 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 n=1 Participants 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.
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. H1N1 - PCR negative, cell culture negative	11 participants	3 participants	0 participants	—
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. H1N1 - PCR negative, cell culture positive	4 participants	0 participants	1 participants	—
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. H1N1 - PCR positive, cell culture negative	5 participants	3 participants	0 participants	—
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. H3N2 - PCR negative, cell culture negative	7 participants	2 participants	0 participants	—
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. H3N2 - PCR positive, cell culture positive	5 participants	0 participants	1 participants	—
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. H1N1 - PCR positive, cell culture positive	1 participants	0 participants	0 participants	—
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. H3N2 - PCR negative, cell culture positive	0 participants	0 participants	0 participants	—
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. H3N2 - PCR positive, cell culture negative	9 participants	4 participants	0 participants	—

SECONDARY outcome

Timeframe: Day 8 post vaccination

Population: The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.

Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=1 Participants 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.
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. H1N1 - PCR negative, cell culture negative	1 participants	—	—	—
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. H1N1 - PCR negative, cell culture positive	0 participants	—	—	—
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. H3N2 - PCR positive, cell culture negative	0 participants	—	—	—
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. H3N2 - PCR positive, cell culture positive	0 participants	—	—	—
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. H1N1 - PCR positive, cell culture negative	0 participants	—	—	—
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. H1N1 - PCR positive, cell culture positive	0 participants	—	—	—
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. H3N2 - PCR negative, cell culture negative	1 participants	—	—	—
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. H3N2 - PCR negative, cell culture positive	0 participants	—	—	—

SECONDARY outcome

Timeframe: Day 2 and 8 post vaccination

Population: All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.

Breast milk was collected from all maternal participants prior at Days 2 and 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=73 Participants 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 n=47 Participants 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 n=19 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=12 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination. Day 2 - Influenza A	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination. Day 2- Influenza B	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination. Day 8 - Influenza B	0 participants	0 participants	0 participants	0 participants
Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination. Day 8 - Influenza A	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 0 and Day 28 post vaccination

Population: All enrolled maternal participants with results reported are included in this analysis population.

Blood was collected from maternal subjects on Day 0 prior to vaccination, and at Day 28 post vaccination for assessment of IgA and IgG antibodies with a standard ELISA assay. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons' vaccines, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.

Outcome measures

Outcome measures
Measure	Maternal LAIV n=75 Participants 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 n=48 Participants 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 n=74 Participants Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=50 Participants Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgA to A/California/7/2009 (H1N1)	180.3 units/mL Interval 132.2 to 245.9	248.8 units/mL Interval 163.4 to 378.6	220.0 units/mL Interval 156.6 to 309.2	212.9 units/mL Interval 140.7 to 322.1
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgA to A/California/7/2009 (H1N1)	211.0 units/mL Interval 152.5 to 291.9	281.0 units/mL Interval 193.6 to 407.8	845.3 units/mL Interval 559.9 to 1276.2	417.2 units/mL Interval 273.9 to 635.4
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgA to A/Perth/16/2009 (H3N2)	724.2 units/mL Interval 527.3 to 994.6	1065.7 units/mL Interval 734.4 to 1546.5	611.2 units/mL Interval 466.1 to 801.5	697.7 units/mL Interval 512.0 to 950.8
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgA to A/Perth/16/2009 (H3N2)	949.6 units/mL Interval 690.2 to 1306.5	1400.9 units/mL Interval 1010.8 to 1941.5	1514.9 units/mL Interval 1154.3 to 1988.3	1262.5 units/mL Interval 913.4 to 1745.1
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgA to A/Victoria/361/2011 (H3N2)	697.7 units/mL Interval 509.7 to 955.1	986.4 units/mL Interval 685.6 to 1419.2	601.9 units/mL Interval 457.9 to 791.1	678.2 units/mL Interval 491.7 to 935.6
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgA to A/Victoria/361/2011 (H3N2)	920.1 units/mL Interval 669.7 to 1264.1	1308.8 units/mL Interval 949.5 to 1804.0	1455.3 units/mL Interval 1103.2 to 1919.6	1206.2 units/mL Interval 875.5 to 1661.9
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgA to B/Brisbane/60/2008	459.4 units/mL Interval 361.9 to 583.1	632.6 units/mL Interval 440.0 to 909.7	408.3 units/mL Interval 310.6 to 536.7	532.1 units/mL Interval 376.2 to 752.7
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgA to B/Brisbane/60/2008	637.2 units/mL Interval 505.9 to 802.7	745.8 units/mL Interval 510.8 to 1089.1	753.0 units/mL Interval 561.9 to 1009.2	933.4 units/mL Interval 648.0 to 1344.6
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgA to B/Wisconsin/1/2010	217.5 units/mL Interval 172.2 to 274.7	264.9 units/mL Interval 183.3 to 382.7	228.3 units/mL Interval 176.1 to 295.9	276.4 units/mL Interval 196.1 to 389.4
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgA to B/Wisconsin/1/2010	281.3 units/mL Interval 226.8 to 348.9	382.0 units/mL Interval 265.0 to 550.6	314.1 units/mL Interval 241.5 to 408.5	1034.3 units/mL Interval 625.1 to 1711.3
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgG to A/California/7/2009 (H1N1)	1224.8 units/mL Interval 988.8 to 1517.1	1014.6 units/mL Interval 764.2 to 1347.0	1133.5 units/mL Interval 876.4 to 1465.9	1301.6 units/mL Interval 964.9 to 1755.7
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgG to A/California/7/2009 (H1N1)	1193.9 units/mL Interval 963.1 to 1479.9	1078.9 units/mL Interval 823.0 to 1414.5	5834.1 units/mL Interval 4507.4 to 7551.4	3526.6 units/mL Interval 2794.0 to 4451.3
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgG to A/Perth/16/2009 (H3N2)	2228.8 units/mL Interval 1790.2 to 2774.8	2022.0 units/mL Interval 1557.9 to 2624.2	1798.5 units/mL Interval 1375.6 to 2351.5	2244.7 units/mL Interval 1775.8 to 2837.4
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgG to A/Perth/16/2009 (H3N2)	2389.8 units/mL Interval 1931.9 to 2956.2	2296.1 units/mL Interval 1780.8 to 2960.4	5594.7 units/mL Interval 4546.6 to 6884.5	5655.1 units/mL Interval 4556.8 to 7018.0
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgG to A/Victoria/361/2011 (H3N2)	2496.3 units/mL Interval 1998.8 to 3117.7	2065.7 units/mL Interval 1537.6 to 2775.2	2018.9 units/mL Interval 1566.0 to 2602.8	2242.8 units/mL Interval 1724.4 to 2917.1
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgG to A/Victoria/361/2011 (H3N2)	2742.3 units/mL Interval 2217.6 to 3391.3	2275.6 units/mL Interval 1697.7 to 3050.3	6132.1 units/mL Interval 4993.7 to 7530.0	5996.0 units/mL Interval 4676.6 to 7687.7
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgG to B/Brisbane/60/2008	2844.8 units/mL Interval 2240.9 to 3611.4	2225.8 units/mL Interval 1630.4 to 3038.7	2159.5 units/mL Interval 1716.8 to 2716.2	2617.4 units/mL Interval 2069.6 to 3310.3
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgG to B/Brisbane/60/2008	3064.5 units/mL Interval 2465.3 to 3809.3	2381.0 units/mL Interval 1760.7 to 3219.9	5813.6 units/mL Interval 4851.7 to 6966.1	3897.7 units/mL Interval 3149.6 to 4823.5
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 0 IgG to B/Wisconsin/1/2010	1279.6 units/mL Interval 988.2 to 1656.8	919.4 units/mL Interval 652.0 to 1296.5	1071.2 units/mL Interval 840.9 to 1364.6	1532.9 units/mL Interval 1146.3 to 2049.9
ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects Day 28 IgG to B/Wisconsin/1/2010	1337.2 units/mL Interval 1048.0 to 1706.4	1185.2 units/mL Interval 868.5 to 1617.3	1914.0 units/mL Interval 1586.3 to 2309.3	5840.2 units/mL Interval 4417.0 to 7722.0

Adverse Events

Maternal LAIV

Serious events: 1 serious events

Other events: 106 other events

Deaths: 0 deaths

Maternal TIV

Serious events: 0 serious events

Other events: 122 other events

Deaths: 0 deaths

Infant LAIV

Serious events: 2 serious events

Other events: 102 other events

Deaths: 0 deaths

Infant TIV

Serious events: 1 serious events

Other events: 101 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maternal LAIV n=124 participants at risk 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 n=124 participants at risk 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 n=124 participants at risk Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.	Infant TIV n=125 participants at risk Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
Pregnancy, puerperium and perinatal conditions Retained placenta or membranes	0.81% 1/124 • Number of events 1 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/125 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.
Congenital, familial and genetic disorders Congenital syphilis	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.81% 1/124 • Number of events 1 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/125 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.
Infections and infestations Urinary tract infection	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.81% 1/124 • Number of events 2 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/125 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.00% 0/124 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.	0.80% 1/125 • Number of events 1 • Solicited systemic and local symptoms were collected for 8 days after vaccination (maternal), 10 days (infant). Unsolicited AEs were collected for 28 days and SAEs and new onset chronic medical conditions were collected for 6 months after vaccination. For events solicited on the Memory Aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period for maternal arms, 10 days for infant arms. Number at risk is 0 for infant arms for events solicited only for maternal arms, and 0 for maternal arms for events solicited only for infants.

Other adverse events

Additional Information

Mark Steinhoff, MD

Cincinnati Children's Hospital Medical Center

Phone: 513-636-2791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60