Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00366899

Last updated date
Study Location
Napoli, Campania, 80122, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Pneumococcal
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
75-105 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged 3 months (75 to 105 days) at time of enrollment.

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

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

4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.

5. Parent(s)/legal guardian(s) had to 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 vaccine.


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


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


4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, or 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 or Hib.


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,
hydrocephalus, or other significant disorders. Did not include resolving syndromes due
to birth trauma such as Erb palsy.


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


11. Participation in another investigational trial. Participation in purely observational
studies was acceptable.


12. Infant who was a direct descendant (eg, child or grandchild) of the study site
personnel.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title  ICMJE A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
  • Biological: 7 valent pneumococcal conjugate vaccine
    Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
Study Arms  ICMJE
  • Experimental: 1
    13-valent pneumococcal conjugate vaccine
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: 2
    7-valent pneumococcal conjugate vaccine
    Intervention: Biological: 7 valent pneumococcal conjugate vaccine
Publications * Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinón-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

*   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: January 17, 2013)
605
Original Enrollment  ICMJE
 (submitted: August 18, 2006)
600
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Aged 3 months (75 to 105 days) at time of enrollment.
  2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
  5. Parent(s)/legal guardian(s) had to be 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, polio, or hepatitis B vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or 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 or Hib.
  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, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
  10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® [MedImmune]).
  11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
  12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 75 Days to 105 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366899
Other Study ID Numbers  ICMJE 6096A1-500
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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Italy, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date January 2013

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