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Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

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NCT01392378

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Gabinet Lekarski
Debica, , 39-200 Poland
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 Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
56-98 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Aged 2 months (56 to 98 days) at time of enrollment.

- Healthy infant as determined by medical history, physical examination, and judgment of
the investigator.

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, diphtheria,
tetanus, pertussis, polio, or Hib conjugate vaccines.

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

- Allergy or contraindication to paracetamol or ibuprofen administration.

- Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus,
pertussis, polio, Hib, or HBV vaccines.

NCT01392378
Pfizer
Completed
Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

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Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants
The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Vaccines
  • Biological: 13-valent pneumococcal conjugate vaccine
    13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
  • Biological: INFANRIX hexa
    INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
  • Drug: Paracetamol
    Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
  • Drug: Ibuprofen
    Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
  • Drug: Paracetamol
    Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
  • Drug: Ibuprofen
    Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
  • Experimental: Group 1
    Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: INFANRIX hexa
    • Drug: Paracetamol
  • Experimental: Group 2
    Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: INFANRIX hexa
    • Drug: Ibuprofen
  • Experimental: Group 3
    Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: INFANRIX hexa
    • Drug: Paracetamol
  • Experimental: Group 4
    Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: INFANRIX hexa
    • Drug: Ibuprofen
  • Experimental: Group 5
    Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: INFANRIX hexa
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
908
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 2 months (56 to 98 days) at time of enrollment.
  • Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Allergy or contraindication to paracetamol or ibuprofen administration.
  • Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
Sexes Eligible for Study: All
56 Days to 98 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01392378
B1851047
6096A1-4027
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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