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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Torun, Bydgoszcz, 87-100 Poland
Contact
1-800-718-1021
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
41-99 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged 2 months (42 to 98 days) at time of enrollment.

2. Available for entire study period and whose parent/legal guardian can be reached by
telephone.

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

4. Parent/legal guardian must be able to complete all relevant study procedures during
study participation.

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

1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate,
diphtheria, tetanus, pertussis, or polio vaccines.

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

3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.

4. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

5. Known or suspected immune deficiency or suppression.

6. History of culture-proven invasive disease caused by S pneumoniae.

7. Major known congenital malformation or serious chronic disorders.

8. Significant neurological disorder or history of seizure including febrile seizure, or
significant stable or evolving disorders such as cerebral palsy, encephalopathy,
hydrocephalus, or other significant disorders. Does not include resolving syndromes
due to birth trauma such as Erb palsy.

9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies; eg, Synagis®).

10. Participation in another investigational or interventional trial. Participation in
purely observational studies is acceptable.

11. Infant who is a direct descendant (child or grandchild) of a member of the study site
personnel.

NCT00464945
Pfizer
Completed
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine
The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Vaccines
Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
  • Experimental: 1
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Aged 2 months (42 to 98 days) at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
  3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. Known or suspected immune deficiency or suppression.
  6. History of culture-proven invasive disease caused by S pneumoniae.
  7. Major known congenital malformation or serious chronic disorders.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
  9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Sexes Eligible for Study: All
41 Days to 99 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00464945
6096A1-3000
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Poland, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2012

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

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[email protected]



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