Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: MultivalentBiological: Prevnar 13
- Registration Number
- NCT03550313
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 565
- Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
- Healthy infant determined by medical history, physical examination, and clinical judgment.
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
- Previous receipt of >1 dose of hepatitis B vaccine.
- Prior hepatitis B vaccine must have been administered at age <30 days.
- Major known congenital malformation or serious chronic disorder.
- Receipt of blood/plasma products or immunoglobulins.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 - Staggered Administration Multivalent Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 Group 1 - Coadministration Prevnar 13 Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 Group 3 - Control with Supplemental Dose Multivalent Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine Group 3 - Control with Supplemental Dose Prevnar 13 Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine Group 1 - Coadministration Multivalent Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 Group 2 - Staggered Administration Prevnar 13 Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13
- Primary Outcome Measures
Name Time Method Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Within 7 Days After Dose 2 Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device 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 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Dose 4 Within 7 Days After Dose 4 Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device 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 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Within 7 Days After Dose 1 Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device 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 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Dose 3 Within 7 Days After Dose 3 Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device 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 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD) Within 7 Days After Supplemental Dose Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device 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 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Within 7 Days After Dose 1 Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (\>=) 38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Within 7 Days After Dose 2 Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Dose 3 Within 7 Days After Dose 3 Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose Within 7 Days After Supplemental Dose Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months) An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4 From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month) An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month) An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Percentage of Participants With Systemic Events Within 7 Days After Dose 4 Within 7 Days After Dose 4 Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study From Dose 1 to End of the Study (up to duration of 17 months) An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study From Dose 1 to End of the Study (up to duration of 17 months) An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.
- Secondary Outcome Measures
Name Time Method Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3 1 Month After Dose 3 IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 1 Month after Dose 3 Percentage of participants with pre-specified IgG concentration (\>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4 1 Month After Dose 4 IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.
Trial Locations
- Locations (47)
Emmaus Research Center, Inc.
🇺🇸Anaheim, California, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Mobile Pediatric Clinic
🇺🇸Mobile, Alabama, United States
LSUHSC-Shreveport
🇺🇸Shreveport, Louisiana, United States
Child Health care Associates
🇺🇸East Syracuse, New York, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Bio-Medical Research, LLC
🇺🇸Miami, Florida, United States
Floating Hospital for Children at Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Tufts Medical Center IDS - Pharmacy
🇺🇸Boston, Massachusetts, United States
Pediatric Associates
🇺🇸Houston, Texas, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Huntington Beach, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Center for Clinical Trials
🇺🇸Paramount, California, United States
Gentle Medicine Associates
🇺🇸Boynton Beach, Florida, United States
Next Phase Research Alliance
🇺🇸Homestead, Florida, United States
Crystal Biomedical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Advocate Children's Hospital
🇺🇸Park Ridge, Illinois, United States
Michael W. Simon, MD, PSC
🇺🇸Lexington, Kentucky, United States
Children's Physicians Embassy Park
🇺🇸Omaha, Nebraska, United States
Creighton University Clinical Research Office
🇺🇸Omaha, Nebraska, United States
Meridian Clinical Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Tekton Research, Inc.
🇺🇸San Antonio, Texas, United States
Parkside Pediatrics
🇺🇸Greenville, South Carolina, United States
Sugarcamp Family Research
🇺🇸Dayton, Ohio, United States
Ventavia Research Group
🇺🇸Keller, Texas, United States
Ochsner-LSU Health Shreveport
🇺🇸Shreveport, Louisiana, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Children's Physicians Spring Valley
🇺🇸Omaha, Nebraska, United States
MedPharmics, LLC
🇺🇸Metairie, Louisiana, United States
Sanford 69th & Louise Family Medicine
🇺🇸Sioux Falls, South Dakota, United States
Mercury Clinical Research
🇺🇸Houston, Texas, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Allegheny Health and Wellness Pavilion
🇺🇸Erie, Pennsylvania, United States
Dixie Pediatrics
🇺🇸Saint George, Utah, United States
Harrisburg Family Medical Center
🇺🇸Harrisburg, Arkansas, United States
Orange County Research Institute
🇺🇸Ontario, California, United States
MOC Research
🇺🇸Mishawaka, Indiana, United States
IACT Health
🇺🇸Columbus, Georgia, United States
All Children Pediatrics
🇺🇸Louisville, Kentucky, United States
Pediatric Phlebotomy
🇺🇸Boston, Massachusetts, United States
Blue Ridge Pediatric and Adolescent Medicine, Inc
🇺🇸Boone, North Carolina, United States
Children's Mercy Clinics on Broadway
🇺🇸Kansas City, Missouri, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
Sanford Children's Specialty Clinic
🇺🇸Sioux Falls, South Dakota, United States
Ventavia Research Group, LLC
🇺🇸Spring, Texas, United States
Marshall Health
🇺🇸Huntington, West Virginia, United States