Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: 13vPnCBiological: Multivalent
- Registration Number
- NCT03512288
- Lead Sponsor
- Pfizer
- Brief Summary
A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
- Detailed Description
NOTE: Detailed description has not been entered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 460
- 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 to be eligible for the study.
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
- 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 Control 13vPnC 13vPnC Multivalent Multivalent Pneumococcal conjugate vaccines
- Primary Outcome Measures
Name Time Method Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 Within 7 days after Vaccination 3 Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree 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 (disabled, 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).
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 Within 7 days after Vaccination 3 Local reactions were recorded using an electronic diary. 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 (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Within 7 days after Vaccination 2 Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree 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 (disabled, 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).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 Within 7 days after Vaccination 4 Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree 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 (disabled, 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).
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Within 7 days after Vaccination 2 Local reactions were recorded using an electronic diary. 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 (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 Within 7 days after Vaccination 4 Local reactions were recorded using an electronic diary. 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 (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months) An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Within 7 days after Vaccination 1 Local reactions were recorded using an electronic diary. 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 (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Within 7 days after Vaccination 1 Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree 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 (disabled, 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).
Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 From Vaccination 4 to 1 month after Vaccination 4 An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months) An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
- Secondary Outcome Measures
Name Time Method Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4 1 Month after Vaccination 4 IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3 1 month after Vaccination 3 Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per milliliter, for serotype 5: \>=0.23 microgram per milliliter, for serotype 6B: \>=0.10 microgram per milliliter and for serotype 19A: \>=0.12 microgram per milliliter.
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3 1 month after Vaccination 3 IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Trial Locations
- Locations (35)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Pediatric Associates of Mt. Carmel, Inc.
🇺🇸Cincinnati, Ohio, United States
St. Joseph Heritage Healthcare
🇺🇸Huntington Beach, California, United States
Premier Health Research Center, LLC
🇺🇸Downey, California, United States
Kaiser Permanente Oakland
🇺🇸Oakland, California, United States
Orange County Research Institute
🇺🇸Ontario, California, United States
Kaiser Permanente San Jose
🇺🇸San Jose, California, United States
Kaiser Permanente South Sacramento
🇺🇸Sacramento, California, United States
LSUHSC Shreveport
🇺🇸Shreveport, Louisiana, United States
ACC Pediatric Research
🇺🇸Haughton, Louisiana, United States
Children's Physicians, Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Kaiser Permanente Santa Clara
🇺🇸Santa Clara, California, United States
MedPharmics, LLC
🇺🇸Metairie, Louisiana, United States
Child Health Care Associates
🇺🇸East Syracuse, New York, United States
Blue Ridge Pediatric and Adolescent Medicine, Inc.
🇺🇸Boone, North Carolina, United States
Capitol Pediatrics & Adolescent Center PLLC
🇺🇸Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Ohio Pediatric Research Association, Inc.
🇺🇸Dayton, Ohio, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Oklahoma State University - Center for Health Sciences
🇺🇸Tulsa, Oklahoma, United States
Allegheny Health and Wellness Pavilion
🇺🇸Erie, Pennsylvania, United States
CCP - Kid's Way
🇺🇸Hermitage, Pennsylvania, United States
Coastal Pediatric Associates
🇺🇸Charleston, South Carolina, United States
Wasatch Pediatrics, Cottonwood Office
🇺🇸Murray, Utah, United States
Wee Care Pediatrics
🇺🇸Syracuse, Utah, United States
Tekton Research, Inc.
🇺🇸San Antonio, Texas, United States
CopperView Medical Center
🇺🇸South Jordan, Utah, United States
Pediatric Associates of Charlottesville, PLC
🇺🇸Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Palmetto Pediatrics, PA
🇺🇸North Charleston, South Carolina, United States
Northwest Arkansas Pediatrics
🇺🇸Fayetteville, Arkansas, United States
University Health Shreveport
🇺🇸Shreveport, Louisiana, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States