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

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NCT03512288

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Northwest Arkansas Pediatrics
Fayetteville, Arkansas, 72703 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 to be eligible for the study.

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 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

- Major known congenital malformation or serious chronic disorder. Receipt of
blood/plasma products or immunoglobulins

NCT03512288
Pfizer
Active, not recruiting
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
A Phase 2, Randomized, Double-blind Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Infants
A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
NOTE: Detailed description has not been entered.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
    Other Name: Pneumococcal conjugate vaccine
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine
  • Experimental: Multivalent
    Pneumococcal conjugate vaccines
    Intervention: Biological: Multivalent
  • Active Comparator: Control
    13vPnC
    Intervention: Biological: 13vPnC
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
460
Same as current
November 26, 2019
November 26, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03512288
B7471003
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now