Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

NCT03512288 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: B7471003
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 39

Brief Summary

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants With Local Reactions 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).

  Within 7 days after Vaccination 1

• Percentage of Participants With Local Reactions 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).

  Within 7 days after Vaccination 2

• Percentage of Participants With Local Reactions 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).

  Within 7 days after Vaccination 3

• Percentage of Participants With Local Reactions 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).

  Within 7 days after Vaccination 4

• Percentage of Participants With Systemic Events 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).

  Within 7 days after Vaccination 1

• Percentage of Participants With Systemic Events 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).

  Within 7 days after Vaccination 2

• Percentage of Participants With Systemic Events 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).

  Within 7 days after Vaccination 3

• Percentage of Participants With Systemic Events 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).

  Within 7 days after Vaccination 4

• Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3

  An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.

  From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)

• Percentage of Participants With Adverse Events (AEs) 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.

  From Vaccination 4 to 1 month after Vaccination 4

• Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4

  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.

  From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)

• Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4

  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.

  From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)

Secondary Outcomes (3)

• Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3

  1 month after Vaccination 3

• Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3

  1 month after Vaccination 3

• Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4

  1 Month after Vaccination 4

Study Arms (2)

Multivalent

EXPERIMENTAL

Pneumococcal conjugate vaccines

Biological: Multivalent

Control

ACTIVE COMPARATOR

13vPnC

Biological: 13vPnC

Interventions

Multivalent BIOLOGICAL

Pneumococcal conjugate vaccine

Also known as: Pneumococcal conjugate vaccine

Multivalent

13vPnC BIOLOGICAL

Pneumococcal conjugate vaccine

Control

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

Northwest Arkansas Pediatrics

Fayetteville, Arkansas, 72703, United States

Location

Premier Health Research Center, LLC

Downey, California, 90240, United States

Location

St. Joseph Heritage Healthcare

Huntington Beach, California, 92648, United States

Location

Kaiser Permanente Oakland

Oakland, California, 94611, United States

Location

Orange County Research Institute

Ontario, California, 91762, United States

Location

Kaiser Permanente South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

LSUHSC Shreveport

Shreveport, Louisiana, 71103, United States

Location

University Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

Children's Physicians, Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Child Health Care Associates

East Syracuse, New York, 13057, United States

Location

Blue Ridge Pediatric and Adolescent Medicine, Inc.

Boone, North Carolina, 28607, United States

Location

Capitol Pediatrics & Adolescent Center PLLC

Raleigh, North Carolina, 27609, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45206, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45225, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Pediatric Associates of Mt. Carmel, Inc.

Cincinnati, Ohio, 45245, United States

Location

Ohio Pediatric Research Association, Inc.

Dayton, Ohio, 45414, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Oklahoma State University - Center for Health Sciences

Tulsa, Oklahoma, 74127, United States

Location

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

Location

CCP - Kid's Way

Hermitage, Pennsylvania, 16148, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

Palmetto Pediatrics, PA

North Charleston, South Carolina, 29406-9170, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-1115, United States

Location

Tekton Research, Inc.

San Antonio, Texas, 78240, United States

Location

Wee Care Pediatrics

Layton, Utah, 84041, United States

Location

Wasatch Pediatrics, Cottonwood Office

Murray, Utah, 84107, United States

Location

Wee Care Pediatrics

Roy, Utah, 84067, United States

Location

CopperView Medical Center

South Jordan, Utah, 84095, United States

Location

Wee Care Pediatrics

Syracuse, Utah, 84075, United States

Location

Pediatric Associates of Charlottesville, PLC

Charlottesville, Virginia, 22902, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Related Publications (1)

• Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277.

  PMID: 34525007 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Vaccines, Combined; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures; Streptococcal Vaccines; Bacterial Vaccines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 30, 2018
• Study Start: April 16, 2018
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (39)