mPnC candidate
Biologicalmonovalent pneumococcal conjugate candidate
NCT Number: NCT06116591
The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age.
All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.
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Notify Me11 month–15 month
All sexes
Interventional
Phase 2
FVR, Kokkolan rokotetutkimusklinikka, Kokkola, Keski-Pohjanmaa, Finland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
monovalent pneumococcal conjugate candidate
monovalent pneumococcal conjugate control
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)
Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)
Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 cm, moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)
Fever (oral temperature >= 38 degree Celsius [degC]) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.
Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)
Fever (oral temperature >= 38 degC) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.
Time frame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
Time frame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator.
Time frame: 1 month after Dose 1
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution).
Time frame: 1 month after Dose 2
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution).
Time frame: 1 month after Dose 1
Predefined IgG concentrations was >= 0.35 micrograms per milliliter (mcg/mL).
Time frame: 1 month after Dose 2
Predefined level of IgG concentrations was >= 0.35 mcg/mL.
Time frame: From before Dose 1 to 1 month after Dose 1
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: From 1 month after Dose 1 to 1 month after Dose 2
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: 1 month after Dose 1
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Time frame: 1 month after Dose 2
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
Time frame: From before Dose 1 to 1 month after Dose 1
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Time frame: From 1 month after Dose 1 to 1 month after Dose 2
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Pfizer
Industry
A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of a Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 11 Through 15 Months of Age Who Previously Received the PCV10 Primary Series
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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