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

• ClinicalTrials.gov Identifier: NCT03512288
• Recruitment Status: Active, not recruiting
• First Posted: April 30, 2018
• Last Update Posted: April 25, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 11, 2018
• First Posted Date: April 30, 2018
• Last Update Posted Date: April 25, 2019
• Actual Study Start Date: April 16, 2018
• Estimated Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2018)

• Percentage of subjects reporting prompted local reactions within 7 days after a dose (redness, swelling, and pain at the injection site) [ Time Frame: Day 7 ]
  Describe prompted local reactions after a dose.
• Percentage of subjects reporting prompted systemic events within 7 days after a dose (fever, decreased appetite, irritability, and drowsiness/increased sleep). [ Time Frame: Day 7 ]
  Describe prompted systemic reactions after a dose.
• Percentages of subjects reporting adverse events (AEs) occurring from Dose 1 to 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
  Describe adverse events occurring from Dose 1 to 1 month after Dose 3
• Percentages of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) occurring from Dose 1 to 6 months following Dose 4. [ Time Frame: 6 months after Dose 4 ]
  Describe SAEs and NDCMCs occurring from Dose 1 to 6 months after Dose 4.
• Percentages of subjects reporting adverse events (AEs) occurring from Dose 4 to 1 month after Dose 4. [ Time Frame: 1 month after Dose 4 ]
  Describe adverse events occurring from Dose 4 to 1 month after Dose 4.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03512288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 27, 2018)

• Pneumococcal serotype-specific IgG concentrations 1 month after Dose 3. [ Time Frame: 1 month after Dose 3 ]
  Describe IgG concentrations 1 month after Dose 3.
• Pneumococcal serotype-specific IgG concentrations 1 month after Dose 4. [ Time Frame: 1 month after Dose 4 ]
  Describe IgG concentrations 1 month after Dose 4.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
• Official Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Pneumococcal Infections

Intervention

• Biological: Multivalent
  Pneumococcal conjugate vaccine
  Other Name: Pneumococcal conjugate vaccine
• Biological: 13vPnC
  Pneumococcal conjugate vaccine

Study Arms

• Experimental: Multivalent
  Pneumococcal conjugate vaccines
  Intervention: Biological: Multivalent
• Active Comparator: Control
  13vPnC
  Intervention: Biological: 13vPnC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 27, 2018): 460
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2020
• Estimated Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 42 Days to 98 Days (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03512288
• Other Study ID Numbers: B7471003
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2019