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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
NZOZ "HIPOKRATES-II" Sp. z o.o.
Krakow, , 31-223 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
13-valent Pneumococcal Vaccine, Premature Birth, Immunization, Safety
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

- Healthy Infants between 42 and 98 days of age (approximately 2 months) 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 pneumococcal vaccine,Haemophilus influenzae type B (Hib)
conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus,
pertussis, or poliovirus vaccines.

- Previous anaphylactic reaction or allergy to any vaccine

- Contraindication to vaccination

- Known or suspected immune deficiency or immune suppression

- Major known congenital malformation or serious chronic disorder

- Significant neurological disorder

- Participation to another study

NCT01193335
Pfizer
Completed
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

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Descriptive Information
Brief Title  ICMJE Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Official Title  ICMJE A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants
Brief SummaryThe purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.
Detailed DescriptionNot 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
  • 13-valent Pneumococcal Vaccine
  • Premature Birth
  • Immunization
  • Safety
Intervention  ICMJE Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Study Arms  ICMJE
  • Active Comparator: Group 1: Preterm infants
    Infant born at < 37 weeks of gestation.
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: Group 2: Term infants
    Infants born at ? 37 weeks of gestation
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Publications *


*   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: August 31, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion DateJanuary 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.

Exclusion Criteria:

  • Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
  • Previous anaphylactic reaction or allergy to any vaccine
  • Contraindication to vaccination
  • Known or suspected immune deficiency or immune suppression
  • Major known congenital malformation or serious chronic disorder
  • Significant neurological disorder
  • Participation to another study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01193335
Other Study ID Numbers  ICMJE B1851037
6096A1-4001 ( Other Identifier: Alias Study Number )
2009-017332-41 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2016

ICMJE     Data element required by the

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

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

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