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

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NCT00366340

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Study Location
Bad Kreuznach, , 55543, Germany
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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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
56-112 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged 2 months (56 to 112 days) at time of enrollment.

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

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

4. Parent(s) or 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 H influenzae type
b.


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®).


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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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Official Title  ICMJE A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.
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 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.
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 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
  • Biological: 7-valent pneumococcal conjugate vaccine
    Single 0.5mL dose given at 2, 3, 4 and 11 to 12 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 * Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.

*   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: June 28, 2012)		604
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 2 months (56 to 112 days) at time of enrollment.
  2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent(s) or 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 H influenzae type b.
  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®).
  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 56 Days to 112 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366340
Other Study ID Numbers  ICMJE 6096A1-006
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 Germany, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2012

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