This is a Phase 4, open-label, single-arm, multicenter study in which subjects 6 to 17 years of age will receive 1 dose of 13vPnC.
A Phase 4, open-label, single-arm, multicenter study to describe the safety of 13-valent Pneumococcal Conjugate Vaccine in children 6 to 17 years of age in India.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
All subjects receive a single dose (0.5mL) of 13vPnC
Manipal Hospital / Department of Pediatrics
Bengaluru, Karnataka, India
KEM Hospital Research Centre
Pune, Maharashtra, India
Christian Medical College
Ludhiana, Punjab, India
Kanchi Kamakoti CHILDS Trust Hospital
Chennai, Tamil Nadu, India
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination
Local reactions (redness, swelling and pain \[tenderness\]) at the 13vPnC injection site were monitored daily for 7 days after vaccination. Redness and swelling were measured and recorded in a measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as; any (any redness or swelling at the injection site), mild (1 to 4 measuring device units = 0.5 to 2.0 cm), moderate (5 to 14 measuring device units = 2.5 to 7.0 cm) and severe (greater than \[\>\]14 measuring device units = \>7.0 cm). Pain (tenderness) at injection site was categorized as; any: any pain at the injection site, mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
Time frame: Within 7 days after vaccination on Day 1 (up to Day 7)
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination
Systemic events included fever, fatigue(tiredness), headache, muscle pain, joint pain, vomiting and diarrhea. Fever: greater than or equal to (\>=) 38.0 degrees Celsius (C), \>=38.0 degrees C to \<=38.4 degrees C, \>=38.5 to \<=38.9 degrees C, 39.0 to 40.0 degrees C, \> 40.0 degrees C. Fatigue, headache, muscle pain and joint pain graded as any (any fatigue, headache, muscle pain, joint pain), mild(did not interfere with activity), moderate(some interference with activity) or severe(prevented daily routine activity). Vomiting was graded as any (any vomiting), mild (1-2 times in 24 hours \[hrs.\]), moderate(\>2 times in 24 hrs.) or severe (required intravenous hydration). Diarrhea was graded as any(any diarrhea), mild (2-3 loose stools in 24 hrs.), moderate(4-5 loose stools in 24 hrs.) or severe(\>=6 loose stools in 24 hrs.)
Time frame: Within 7 days after vaccination on Day 1 (up to Day 7)
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was 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 or that was considered to be an important medical event. Treatment-emergent were events between first dose of study drug and up to 1 month that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
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Time frame: up to 1 month after vaccination on Day 1