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Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hayward, California, 94545 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months
of age) subjects enrolled in the Prevnar arm of Study D118-P8, OR

- Fully vaccinated per-protocol subjects from the control arm of the same study that did
not receive Prevnar after the close of Study D118-P8, or at any time following the
study, AND

- Still enrolled in NCKP health plan.

- Subjects included in either group above must be in good health as determined by
medical history, physical examination, and clinical judgment.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous receipt of pneumococcal polysaccharide vaccine.

- History of documented recurrent pneumococcal otitis media or any occurence of
pneumonia within past 12 months

- History of documented invasive pneumococcal disease (defined as a positive culture of
S. pneumoniae from a normally sterile body site).

- Known or suspected disease or dysfunction of the immune system, including:

- HIV infection

- Malignancy

- Receipt of immunosuppressive therapy

- Sickle cell hemoglobinopathy

- Concomitant vaccination during the study period.

- Known hypersensitivity to any component of Prevnar.

- Any major illness/condition that, in the investigator's judgment, will substantially
increase the risk associated with the subject's participation in and completion of,
the study, or could preclude the evaluation of the subject's response.

- Receipt of immune globulin within the past 3 months.

- Positive pregnancy test for menarchal female subjects.

- Females who are breastfeeding.

- For control subjects, previous receipt of Prevnar at any time.

NCT00824850
Pfizer
Completed
Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort

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Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Characterization of the Prevnar Infant Long-term Immune Response vs a Prevnar Naive Cohort
The purpose of this study is to assess the "late" immune response to further doses of pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the Prevnar naive cohort which received MnCC). The study will take place at a single study center. Study participants must have participated previously in a specific Wyeth Prevnar study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente (NCKP) health plan.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
Other Name: 13vPnC
  • Experimental: 1
    Subjects received Prevnar in study D118-P8
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: 2
    Subjects received MnCC in study D118-P8
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Klein NP, Ensor K, Jouve S, Northington R, Moscariello M, McGovern PC. Long-term immune responses to pneumococcal conjugate vaccines in children previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Sep;32(9):990-7. doi: 10.1097/INF.0b013e3182959f34.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months of age) subjects enrolled in the Prevnar arm of Study D118-P8, OR
  • Fully vaccinated per-protocol subjects from the control arm of the same study that did not receive Prevnar after the close of Study D118-P8, or at any time following the study, AND
  • Still enrolled in NCKP health plan.
  • Subjects included in either group above must be in good health as determined by medical history, physical examination, and clinical judgment.

Exclusion Criteria:

  • Previous receipt of pneumococcal polysaccharide vaccine.
  • History of documented recurrent pneumococcal otitis media or any occurence of pneumonia within past 12 months
  • History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
  • Known or suspected disease or dysfunction of the immune system, including:
  • HIV infection
  • Malignancy
  • Receipt of immunosuppressive therapy
  • Sickle cell hemoglobinopathy
  • Concomitant vaccination during the study period.
  • Known hypersensitivity to any component of Prevnar.
  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.
  • Receipt of immune globulin within the past 3 months.
  • Positive pregnancy test for menarchal female subjects.
  • Females who are breastfeeding.
  • For control subjects, previous receipt of Prevnar at any time.
Sexes Eligible for Study: All
8 Years to 16 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00824850
6096A1-3016
B1851014
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

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 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

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[email protected]



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