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A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878330
Recruitment Status : Completed
First Posted : August 25, 2016
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Respiratory Syncytial Virus Infections
Interventions Drug: MEDI8897
Drug: Placebo
Enrollment 1453
Recruitment Details The study was conducted from 03-Nov-2016 to 06-Dec-2018.
Pre-assignment Details A total of 1540 participants were screened, out of which 1453 participants were randomized in the study.
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study. Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Period Title: Overall Study
Started 484 969
Completed 455 913
Not Completed 29 56
Reason Not Completed
Death             3             2
Lost to Follow-up             11             26
Withdrawal by Subject             11             21
Other             4             7
Arm/Group Title Placebo MEDI8897 50 mg Total
Hide Arm/Group Description Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study. Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study. Total of all reporting groups
Overall Number of Baseline Participants 484 969 1453
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized in the study and analyzed according to their randomized treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 484 participants 969 participants 1453 participants
3.28  (2.31) 3.29  (2.22) 3.29  (2.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 969 participants 1453 participants
Female
224
  46.3%
468
  48.3%
692
  47.6%
Male
260
  53.7%
501
  51.7%
761
  52.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 969 participants 1453 participants
Hispanic or Latino
91
  18.8%
225
  23.2%
316
  21.7%
Not Hispanic or Latino
393
  81.2%
743
  76.7%
1136
  78.2%
Unknown or Not Reported
0
   0.0%
1
   0.1%
1
   0.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 969 participants 1453 participants
American Indian or Alaska Native
1
   0.2%
0
   0.0%
1
   0.1%
Asian
10
   2.1%
5
   0.5%
15
   1.0%
Native Hawaiian or Other Pacific Islander
3
   0.6%
8
   0.8%
11
   0.8%
Black or African American
67
  13.8%
189
  19.5%
256
  17.6%
White
355
  73.3%
693
  71.5%
1048
  72.1%
More than one race
5
   1.0%
12
   1.2%
17
   1.2%
Unknown or Not Reported
43
   8.9%
62
   6.4%
105
   7.2%
1.Primary Outcome
Title Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
Hide Description The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
Time Frame From Day 1 through Day 151
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 484 969
Measure Type: Count of Participants
Unit of Measure: Participants
46
   9.5%
25
   2.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI8897 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 70.1
Confidence Interval (2-Sided) 95%
52.3 to 81.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
Hide Description A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).
Time Frame From Day 1 through Day 151
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 484 969
Measure Type: Count of Participants
Unit of Measure: Participants
20
   4.1%
8
   0.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI8897 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk Reduction
Estimated Value 78.4
Confidence Interval (2-Sided) 95%
51.9 to 90.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame From Day 1 through Day 361
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 479 968
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
416
  86.8%
834
  86.2%
TESAEs
81
  16.9%
108
  11.2%
4.Secondary Outcome
Title Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
Hide Description An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.
Time Frame From Day 1 through Day 361
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 479 968
Measure Type: Count of Participants
Unit of Measure: Participants
AESIs
3
   0.6%
5
   0.5%
NOCDs
4
   0.8%
4
   0.4%
5.Secondary Outcome
Title Serum Concentration of MEDI8897
Hide Description [Not Specified]
Time Frame Days 91, 151, and 361
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
Arm/Group Title MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 968
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Day 91 Number Analyzed 883 participants
35.9  (10.9)
Day 151 Number Analyzed 849 participants
18.9  (7.4)
Day 361 Number Analyzed 771 participants
2.1  (1.1)
6.Secondary Outcome
Title Elimination Half-life (t1/2) of MEDI8897
Hide Description Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.
Time Frame Day 91 through Day 361
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. Participants with sufficient additional pharmacokinetics (PK) samples from unscheduled visits were analysed for this outcome measure.
Arm/Group Title MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 968
Mean (Standard Deviation)
Unit of Measure: Days
59.3  (9.6)
7.Secondary Outcome
Title Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Hide Description The number of participants with positive serum antibodies to MEDI8897 are reported.
Time Frame Days 91, 151, and 361
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description:
Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Overall Number of Participants Analyzed 479 968
Measure Type: Count of Participants
Unit of Measure: Participants
Day 91 Number Analyzed 455 participants 890 participants
4
   0.9%
11
   1.2%
Day 151 Number Analyzed 445 participants 867 participants
6
   1.3%
17
   2.0%
Day 361 Number Analyzed 418 participants 847 participants
8
   1.9%
30
   3.5%
Time Frame From Day 1 through Day 361
Adverse Event Reporting Description As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
 
Arm/Group Title Placebo MEDI8897 50 mg
Hide Arm/Group Description Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study. Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
All-Cause Mortality
Placebo MEDI8897 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/479 (0.63%)      2/968 (0.21%)    
Hide Serious Adverse Events
Placebo MEDI8897 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   81/479 (16.91%)      108/968 (11.16%)    
Blood and lymphatic system disorders     
Anaemia neonatal † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Cardiac disorders     
Cardiac arrest † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Cardiac failure † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Cardiac failure congestive † 1  0/479 (0.00%)  0 1/968 (0.10%)  3
Myocarditis † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Pericardial effusion † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Congenital, familial and genetic disorders     
Muscular dystrophy † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Ear and labyrinth disorders     
Deafness bilateral † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Gastrointestinal disorders     
Abdominal pain † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Diarrhoea † 1  1/479 (0.21%)  1 2/968 (0.21%)  2
Dysphagia † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Enteritis † 1  1/479 (0.21%)  1 1/968 (0.10%)  1
Gastrooesophageal reflux disease † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Incarcerated umbilical hernia † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Inguinal hernia † 1  6/479 (1.25%)  6 1/968 (0.10%)  1
Malabsorption † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Vomiting † 1  0/479 (0.00%)  0 2/968 (0.21%)  2
General disorders     
Death † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Pyrexia † 1  1/479 (0.21%)  1 3/968 (0.31%)  3
Hepatobiliary disorders     
Jaundice † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Immune system disorders     
Drug hypersensitivity † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Infections and infestations     
Abscess limb † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Adenovirus infection † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Anal abscess † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Bronchiolitis † 1  21/479 (4.38%)  26 20/968 (2.07%)  22
Bronchitis † 1  11/479 (2.30%)  11 14/968 (1.45%)  16
Croup infectious † 1  0/479 (0.00%)  0 2/968 (0.21%)  2
Cytomegalovirus infection † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Gastroenteritis † 1  4/479 (0.84%)  5 9/968 (0.93%)  9
Gastroenteritis escherichia coli † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Gastroenteritis adenovirus † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Gastroenteritis rotavirus † 1  2/479 (0.42%)  2 0/968 (0.00%)  0
Gastroenteritis salmonella † 1  1/479 (0.21%)  1 1/968 (0.10%)  1
Gastroenteritis viral † 1  1/479 (0.21%)  2 1/968 (0.10%)  1
Influenza † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Laryngitis † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Lower respiratory tract infection † 1  13/479 (2.71%)  18 14/968 (1.45%)  14
Lower respiratory tract infection viral † 1  3/479 (0.63%)  5 5/968 (0.52%)  5
Meningitis † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Meningitis bacterial † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Otitis media † 1  0/479 (0.00%)  0 2/968 (0.21%)  2
Peritonsillar abscess † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Pharyngitis † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Pneumonia † 1  10/479 (2.09%)  12 13/968 (1.34%)  13
Pneumonia bacterial † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Pneumonia parainfluenzae viral † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Pneumonia respiratory syncytial viral † 1  2/479 (0.42%)  2 2/968 (0.21%)  2
Pneumonia viral † 1  2/479 (0.42%)  2 7/968 (0.72%)  8
Pseudomonal bacteraemia † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Respiratory syncytial virus bronchiolitis † 1  2/479 (0.42%)  2 1/968 (0.10%)  1
Salmonellosis † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Sepsis † 1  1/479 (0.21%)  1 2/968 (0.21%)  2
Sepsis neonatal † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Staphylococcal scalded skin syndrome † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Tonsillitis † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Upper respiratory tract infection † 1  3/479 (0.63%)  3 3/968 (0.31%)  3
Urinary tract infection † 1  4/479 (0.84%)  5 0/968 (0.00%)  0
Viral upper respiratory tract infection † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Injury, poisoning and procedural complications     
Exposure to toxic agent † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Fall † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Palate injury † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Thermal burn † 1  0/479 (0.00%)  0 2/968 (0.21%)  2
Metabolism and nutrition disorders     
Dehydration † 1  1/479 (0.21%)  1 2/968 (0.21%)  2
Hypoglycaemia † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Eyelid haemangioma † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Nervous system disorders     
Cerebrovascular accident † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Febrile convulsion † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Hypotonia † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Infantile spasms † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Intraventricular haemorrhage † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Seizure † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Psychiatric disorders     
Irritability † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis † 1  0/479 (0.00%)  0 2/968 (0.21%)  2
Reproductive system and breast disorders     
Penile adhesion † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnoea † 1  1/479 (0.21%)  1 1/968 (0.10%)  1
Asthma † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Laryngeal stenosis † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
Pneumonia aspiration † 1  0/479 (0.00%)  0 2/968 (0.21%)  2
Pulmonary vein stenosis † 1  0/479 (0.00%)  0 1/968 (0.10%)  1
Skin and subcutaneous tissue disorders     
Dermatitis allergic † 1  1/479 (0.21%)  1 0/968 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo MEDI8897 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   402/479 (83.92%)      804/968 (83.06%)    
Blood and lymphatic system disorders     
Anaemia † 1  17/479 (3.55%)  17 29/968 (3.00%)  29
Congenital, familial and genetic disorders     
Plagiocephaly † 1  3/479 (0.63%)  3 15/968 (1.55%)  15
Gastrointestinal disorders     
Abdominal pain † 1  10/479 (2.09%)  10 5/968 (0.52%)  5
Constipation † 1  21/479 (4.38%)  24 34/968 (3.51%)  36
Diarrhoea † 1  49/479 (10.23%)  55 98/968 (10.12%)  113
Gastrooesophageal reflux disease † 1  22/479 (4.59%)  22 37/968 (3.82%)  38
Teething † 1  32/479 (6.68%)  35 62/968 (6.40%)  72
Umbilical hernia † 1  3/479 (0.63%)  3 11/968 (1.14%)  11
Vomiting † 1  15/479 (3.13%)  17 40/968 (4.13%)  46
General disorders     
Pyrexia † 1  63/479 (13.15%)  75 109/968 (11.26%)  133
Infections and infestations     
Acarodermatitis † 1  8/479 (1.67%)  8 13/968 (1.34%)  15
Bronchiolitis † 1  42/479 (8.77%)  60 83/968 (8.57%)  104
Bronchitis † 1  49/479 (10.23%)  77 91/968 (9.40%)  150
Candida nappy rash † 1  6/479 (1.25%)  6 12/968 (1.24%)  14
Conjunctivitis † 1  39/479 (8.14%)  44 86/968 (8.88%)  94
Croup infectious † 1  6/479 (1.25%)  7 12/968 (1.24%)  13
Ear infection † 1  13/479 (2.71%)  21 23/968 (2.38%)  34
Exanthema subitum † 1  11/479 (2.30%)  11 21/968 (2.17%)  22
Fungal skin infection † 1  8/479 (1.67%)  8 5/968 (0.52%)  5
Gastroenteritis † 1  44/479 (9.19%)  49 115/968 (11.88%)  138
Gastroenteritis viral † 1  5/479 (1.04%)  5 13/968 (1.34%)  15
Hand-foot-and-mouth disease † 1  14/479 (2.92%)  14 36/968 (3.72%)  36
Impetigo † 1  6/479 (1.25%)  6 12/968 (1.24%)  12
Laryngitis † 1  10/479 (2.09%)  10 24/968 (2.48%)  31
Lower respiratory tract infection † 1  46/479 (9.60%)  65 75/968 (7.75%)  103
Lower respiratory tract infection viral † 1  6/479 (1.25%)  8 9/968 (0.93%)  9
Nasopharyngitis † 1  94/479 (19.62%)  158 164/968 (16.94%)  264
Oral candidiasis † 1  26/479 (5.43%)  26 36/968 (3.72%)  39
Otitis media † 1  42/479 (8.77%)  63 63/968 (6.51%)  87
Otitis media acute † 1  24/479 (5.01%)  33 51/968 (5.27%)  82
Pharyngitis † 1  27/479 (5.64%)  32 57/968 (5.89%)  68
Rhinitis † 1  50/479 (10.44%)  61 111/968 (11.47%)  145
Tonsillitis † 1  5/479 (1.04%)  6 16/968 (1.65%)  16
Upper respiratory tract infection † 1  169/479 (35.28%)  337 392/968 (40.50%)  734
Urinary tract infection † 1  7/479 (1.46%)  7 12/968 (1.24%)  12
Varicella † 1  11/479 (2.30%)  11 19/968 (1.96%)  19
Viral rash † 1  15/479 (3.13%)  16 32/968 (3.31%)  34
Viral upper respiratory tract infection † 1  34/479 (7.10%)  57 48/968 (4.96%)  75
Injury, poisoning and procedural complications     
Arthropod bite † 1  6/479 (1.25%)  6 14/968 (1.45%)  14
Vaccination complication † 1  15/479 (3.13%)  19 23/968 (2.38%)  28
Psychiatric disorders     
Irritability † 1  7/479 (1.46%)  14 11/968 (1.14%)  20
Respiratory, thoracic and mediastinal disorders     
Cough † 1  15/479 (3.13%)  17 37/968 (3.82%)  45
Nasal congestion † 1  24/479 (5.01%)  27 71/968 (7.33%)  83
Nasal obstruction † 1  17/479 (3.55%)  17 23/968 (2.38%)  23
Rhinorrhoea † 1  29/479 (6.05%)  34 63/968 (6.51%)  75
Skin and subcutaneous tissue disorders     
Dermatitis † 1  15/479 (3.13%)  15 20/968 (2.07%)  26
Dermatitis atopic † 1  8/479 (1.67%)  9 30/968 (3.10%)  34
Dermatitis diaper † 1  36/479 (7.52%)  44 76/968 (7.85%)  94
Eczema † 1  15/479 (3.13%)  15 34/968 (3.51%)  34
Rash † 1  17/479 (3.55%)  18 43/968 (4.44%)  49
Seborrhoeic dermatitis † 1  7/479 (1.46%)  8 17/968 (1.76%)  17
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. Pamela Griffin
Organization: MedImmune, LLC
Phone: +1 301-398-4059
EMail: information.center@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02878330    
Other Study ID Numbers: D5290C00003
First Submitted: August 22, 2016
First Posted: August 25, 2016
Results First Submitted: July 17, 2019
Results First Posted: October 14, 2019
Last Update Posted: October 14, 2019