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

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NCT01392378

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Study Location
Gabinet Lekarski
Debica, , 39-200, Poland
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccines
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, Czajka H, Hasiec B, Dziduch J, Jackowska T, Witor A, Kopi?ska E, Konior R, Giardina PC, Sundaraiyer V, Patterson S, Gruber WC, Scott DA, Gurtman A. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017 Apr 4;35(15):1926-1935. doi: 10.1016/j.vaccine.2017.02.035. Epub 2017 Mar 3.

*   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: July 8, 2011)		908
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 56 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 Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01392378
Other Study ID Numbers  ICMJE B1851047
6096A1-4027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 2014

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