This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,511
Pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Time frame: Within 7 Days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Time frame: Within 7 Days after Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
Time frame: Within 7 Days after Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.
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Eclipse Clinical Research
Tucson, Arizona, United States
Good Samaritan Family Health Team
Fullerton, California, United States
FocilMed
Oxnard, California, United States
Superior Research, LLC
Sacramento, California, United States
Carey Chronis, MD
Ventura, California, United States
Fomat - Robert Nudelman MD
Westlake Village, California, United States
Ebert Family Clinic
Frisco, Colorado, United States
Advanced Research for Health Improvement, LLC
Fort Myers, Florida, United States
Pensacola Pediatrics
Gulf Breeze, Florida, United States
Y&L Advance Health Care Inc, d/b/a Elite
Miami, Florida, United States
...and 87 more locations
Time frame: Within 7 Days after Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days after Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days after Dose 4
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Dose 1 to 1 Month after Dose 3
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: From Dose 4 to 1 Month after Dose 4
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events.
Time frame: From Dose 1 to 6 Months after Dose 4
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4
An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.
Time frame: From Dose 1 to 6 Months after Dose 4