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

Last updated on December 17, 2017

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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Similar Trials

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
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
The 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • 13-valent Pneumococcal Vaccine
  • Premature Birth
  • Immunization
  • Safety
Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
  • 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
Martinón-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omeñaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisán A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941. Epub 2015 Mar 16.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Spain
 
 
NCT01193335
B1851037
6096A1-4001 ( Other Identifier: Alias Study Number )
2009-017332-41 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

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

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