Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

NCT01900899

Last updated date
Study Location
Espoo Vaccine Research Clinic
Espoo, , 02230, Finland
Contact
1-800-718-1021

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

All subjects must satisfy ALL the following criteria at study entry:

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

- A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.

- Written informed consent obtained from the parent(s)/LAR(s) of the subject.

- Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


The following criteria should be checked at the time of study entry. If ANY exclusion
criterion applies, the subject must not be included in the study:


- Child in care.


- History of meningococcal disease.


- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT:
039 Y2, 3, 4, 5 (112036).


- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.


- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

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Meningococcal InfectionsPersistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
NCT01900899
  1. Espoo,
  2. Helsinki,
  3. Helsinki,
  4. Jarvenpaa,
  5. Oulu,
  6. Pori,
  7. Seinajoki,
  8. Tampere,
  9. Turku,
  10. Vantaa,
ALL GENDERS
0+
years
MULTIPLE SITES
Meningococcal InfectionsImmunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
NCT01939158
  1. Garran, Australian Capital Territory
  2. Westmead, New South Wales
  3. North Adelaide, South Australia
  4. Melbourne, Victoria
  5. Nedlands, Western Australia
  6. Winnipeg, Manitoba
  7. Halifax, Nova Scotia
  8. Hamilton, Ontario
  9. Sudbury, Ontario
  10. Québec City, Quebec
  11. Praha 6, Vokovice
  12. Benesov,
  13. Boletice nad Labem,
  14. Brandys nad Labem,
  15. Caslav,
  16. Chrastava,
  17. Chrudim 2,
  18. Decin,
  19. Domazlice,
  20. Holice,
  21. Hradec Kralove,
  22. Hradek nad Nisou,
  23. Hronov,
  24. Jindrichuv Hradec,
  25. Kladno,
  26. Krupka,
  27. Liberec 7,
  28. Melnik,
  29. Nachod,
  30. Neveklov,
  31. Novy Jicin,
  32. Odolena Voda,
  33. Ostrov Nad Ohri,
  34. Ostrov,
  35. Pardubice,
  36. Pardubice,
  37. Pardubice,
  38. Pardubice,
  39. Praha 3,
  40. Praha 5,
  41. Smirice,
  42. Trutnov,
  43. Tynec nad Sazavou,
  44. Panama,
  45. Panama,
  46. Panama,
  47. Panama,
  48. Gauteng,
  49. Soweto,
  50. Ankara, Sihhiye
  51. Izmir,
ALL GENDERS
12 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Official Title  ICMJE A PHASE III, OPEN, MULTI-CENTRE, CONTROLLED STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 2, 3, 4, 5 AND 6 YEARS AFTER A BOOSTER DOSE OF MENINGOCOCCAL SEROGROUP A, C, W-135, Y- TETANUS TOXOID CONJUGATE VACCINE (MENACWY-TT) OR MENINGITEC (REGISTERED) ADMINISTERED IN HEALTHY 5-YEAR-OLD CHILDREN IN STUDY MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), WHO WERE PRIMED WITH THE SAME VACCINE IN STUDY MENACWY-TT-039 (109670) AT 12 THROUGH 23 MONTHS OF AGE.
Brief Summary The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.
Detailed Description The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infections, Meningococcal
Intervention  ICMJE Procedure: Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
Study Arms  ICMJE
  • Experimental: ACWY-TT group
    Subjects primed and boosted with the MenACWY-TT vaccine.
    Intervention: Procedure: Blood Sampling
  • Active Comparator: MenCCRM group
    Subjects primed and boosted with the Meningitec vaccine.
    Intervention: Procedure: Blood Sampling
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: March 13, 2019)
184
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2013)
249
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

  • Child in care.
  • History of meningococcal disease.
  • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01900899
Other Study ID Numbers  ICMJE MENACWY-TT-102
C0921001 ( Other Identifier: Alias Study Number )
2012-005816-25 ( EudraCT Number )
200088 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2019

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