Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00452452
Previous Study | Return to List | Next Study

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

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: NCT00452452
Recruitment Status : Completed
First Posted : March 27, 2007
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 March 23, 2007
First Posted Date  ICMJE March 27, 2007
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 July 2007
Actual Primary Completion Date March 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 After Vaccination [ Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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) After Vaccination in 13vPnC Groups [ Time Frame: 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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: March 26, 2007)
To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after the last scheduled dose of 13vPnC in each of 3 age groups (Group A = 7-11 months; Group B = 12-23 months; Group C = 24 months-5 years).
Change History Complete list of historical versions of study NCT00452452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2012)
  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ]
    Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ]
    Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
To evaluate the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events (AEs).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Official Title  ICMJE A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE Biological: 13-valent Pneumococcal Conjugate Vaccine
Study Arms  ICMJE Experimental: A
Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Publications * Not Provided

*   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: July 6, 2012)
355
Original Enrollment  ICMJE
 (submitted: March 26, 2007)
354
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged from 7 months to <72 months at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian could be reached by telephone.
  3. Healthy as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with pneumococcal vaccine.
  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 monoclonal antibodies) in the last 3 months.
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Months to 5 Years   (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 NCT00452452
Other Study ID Numbers  ICMJE 6096A1-3002
Has Data Monitoring Committee Not Provided
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