Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

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NCT03550313

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Study Location
Finlay Medical Research
Miami, Florida, 33126, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
Official Title  ICMJE A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
    Other Name: Pneumococcal conjugate vaccine
  • Biological: Prevnar 13
    Pneumococcal conjugate vaccine
Study Arms  ICMJE
  • Experimental: Group 1 - Coadministration
    Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13
    Interventions:
    • Biological: Multivalent
    • Biological: Prevnar 13
  • Experimental: Group 2 - Staggered Administration
    Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13
    Interventions:
    • Biological: Multivalent
    • Biological: Prevnar 13
  • Active Comparator: Group 3 - Control with Supplemental Dose
    Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine
    Interventions:
    • Biological: Multivalent
    • Biological: Prevnar 13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2021)		560
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)		690
Actual Study Completion Date  ICMJE November 5, 2020
Actual Primary Completion Date November 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03550313
Other Study ID Numbers  ICMJE C3571002
2020-005039-59 ( EudraCT Number )
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  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP