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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512288
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Multivalent Biological: 13vPnC Phase 2

Detailed Description:
NOTE: Detailed description has not been entered.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : February 11, 2020
Actual Study Completion Date : February 11, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Multivalent
Pneumococcal conjugate vaccines
 Biological: Multivalent
Pneumococcal conjugate vaccine
Other Name: Pneumococcal conjugate vaccine
Active Comparator: Control
13vPnC
 Biological: 13vPnC
Pneumococcal conjugate vaccine


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   42 Days to 98 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512288


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03512288    
Other Study ID Numbers: B7471003
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs