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13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Medical Research Council Unit, The Gambia
Fajara, The Gambia, West Africa, 000273 Gambia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-70 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Aged 42 to 70 days at enrollment.

- Determined by medical history, physical examination, and clinical judgment to be
eligible for the study

- Weight of 3.5 kg or greater at the time of enrollment

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.

- A previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination with pneumococcal conjugate vaccine.

- Receipt of blood products or gamma-globulin since birth

NCT01964716
Pfizer
Completed
13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

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13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Vaccines
  • Biological: 13-valent pneumococcal conjugate vaccine
    Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
  • Biological: 13-valent pneumococcal conjugate vaccine
    Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
  • Experimental: Multidose Vial Group
    Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: Single-Dose Syringe Group
    Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 42 to 70 days at enrollment.
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study
  • Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal conjugate vaccine.
  • Receipt of blood products or gamma-globulin since birth
Sexes Eligible for Study: All
42 Days to 70 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Gambia
 
 
NCT01964716
B4671001
2012-000482-21 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2015

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

BY EMAIL

Contact

[email protected]



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