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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Espoo Vaccine Research Clinic
Espoo, , 02230 Finland
Contact
1-800-718-1021
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.

NCT01900899
Pfizer
Completed
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

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Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
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.
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infections, Meningococcal
Procedure: Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
193
November 14, 2017
November 14, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01900899
MENACWY-TT-102
C0921001 ( Other Identifier: Alias Study Number )
2012-005816-25 ( EudraCT Number )
200088 ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...

URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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