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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal

Treatments: Procedure: Blood Sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT01900899

C0921001 (Other Identifier)

2012-005816-25 (EudraCT Number)

MENACWY-TT-102

200088 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

ACWY-TT group

Experimental group

Description:

Subjects primed and boosted with the MenACWY-TT vaccine.

Treatment:

Procedure: Blood Sampling

MenCCRM group

Active Comparator group

Description:

Subjects primed and boosted with the Meningitec vaccine.

Treatment:

Procedure: Blood Sampling