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

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NCT03550313

Last updated on November 1, 2018
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FOR MORE INFORMATION
Study Location
Mobile Pediatric Clinic
Mobile, Alabama, 36607 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.

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

- Major known congenital malformation or serious chronic disorder.

- Receipt of blood/plasma products or immunoglobulins.

NCT03550313
Pfizer
Recruiting
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

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[email protected]

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Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
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
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
    Other Name: Pneumococcal conjugate vaccine
  • Biological: Prevnar 13
    Pneumococcal conjugate vaccine
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
690
Same as current
June 9, 2020
June 9, 2020   (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.

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.
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
 
 
NCT03550313
C3571002
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
May 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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