Persistence of antibodies after meningococcal vaccine PF-06866681 in healthy children.

Phase 1

• Conditions: imenrix is indicated for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis serogroup A, C, W-135 and Y.; MedDRA version: 18.1Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862; MedDRA version: 18.1Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-005816-25-FI
• Lead Sponsor: Pfizer Inc (235 East 42nd Street, New York, New York 10017)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 248

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 (e.g. return for follow-up visits).
•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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 248
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 (no laboratory testing required).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified