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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Bydgoszcz, , 85-168 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
42-98 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

2. Available for the entire study period and whose parent(s)/legal guardian(s) could be
reached by telephone.

3. In good health as determined by medical history, physical examination, and judgment of
the investigator.

4. Parent(s)/legal guardian(s) were 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 vaccine.

2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio
vaccines.

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

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, or pneumococcal vaccines.

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

6. Known or suspected immune deficiency or suppression.

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

8. Major known congenital malformation or serious chronic disorder.

9. Significant neurological disorder or history of seizure (including febrile seizure),
or significant stable or evolving disorders (such as cerebral palsy, encephalopathy,
or hydrocephalus), or other significant disorders. This did not include resolving
syndromes because of birth trauma such as Erb palsy.

10. Receipt of blood products or ?-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies [eg, Synagis]).

NCT00366548
Pfizer
Completed
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
  • Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
  • Experimental: 1
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
  • Active Comparator: 2
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Gadzinowski J, Tansey SP, Wysocki J, Kopi?ska E, Majda-Stanis?awska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion criteria:

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

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae.
  8. Major known congenital malformation or serious chronic disorder.
  9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
  10. Receipt of blood products or ?-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00366548
6096A1-009
No
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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