Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00366548
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00366548
Recruitment Status : Completed
First Posted : August 21, 2006
Results First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 17, 2006
First Posted Date  ICMJE August 21, 2006
Results First Submitted Date  ICMJE March 26, 2010
Results First Posted Date  ICMJE August 15, 2012
Last Update Posted Date August 15, 2012
Study Start Date  ICMJE November 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
  • Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series [ Time Frame: One month after 3-dose infant series (at 5 months of age) ]
    Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
  • Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (at 5 months of age) ]
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
To compare immunogenicity of 13vPnC manufactured with Polysorbate 80 to 13vPnC manufactured without Polysorbate 80 using serotype specific serum IgG antibody levels, to assess safety by local injection site reactions, systemic events, and adverse events.
Change History Complete list of historical versions of study NCT00366548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
  • Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose [ Time Frame: one month after the toddler dose (at 13 months of age) ]
    Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
  • Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose [ Time Frame: one month after the toddler dose (at 13 months of age) ]
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal
Intervention  ICMJE
  • Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
  • Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Study Arms  ICMJE
  • 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
Publications * Gadzinowski J, Tansey SP, Wysocki J, Kopińska E, Majda-Stanisławska 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2006)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366548
Other Study ID Numbers  ICMJE 6096A1-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP