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® 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. - C0921001 (MENACWY-TT-102 EXT: 048 Y2, 3, 4, 5, 6)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005816-25-FI

Enrollment

248

Registered

2013-05-17

Start date

2013-06-11

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nimenrix 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: 18.1 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000004862 MedDRA version: 18.1 Level: LLT Classification code 10070124 Term: Neisseria meningitidis test positive System Organ Class: 100000004848

Interventions

Trade Name: Meningitec Product Name: Meningitec Pharmaceutical Form: Suspension for injection INN or Proposed INN: NEISSERIA MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE Other descriptive name: N

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Immunogenicity Persistence At 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec •To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres =1:8 for each of the four serogroups.;Secondary Objective: Immunogenicity Persistence At 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec •To evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of the percentage of subjects with rSBA titres =1:128 and GMTs and hSBA titres =1:4 and =1:8 and GMTs for each of the four serogroups. Safety •To describe serious adverse events (SAEs) related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) up to each yearly visit in the current study in a retrospective manner.;Primary end point(s): • Persistence of antibodies with respect to components of the investigational vaccine, 2, 3, 4, 5, 6 years after booster vaccination: - rSBA-MenA titres =1:8. - rSBA-MenC titres =1:8. - rSBA-MenW-135 titres =1:8. - rSBA-MenY titres =1:8.;Timepoint(s) of evaluation of this end point: Primary vaccination for 12 to 23 Months, and then a booster vaccination 4 years after that and then 6 years persistence	—

Measure

Time frame

Main Objective: Immunogenicity Persistence At 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec •To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres =1:8 for each of the four serogroups.;Secondary Objective: Immunogenicity Persistence At 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec •To evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of the percentage of subjects with rSBA titres =1:128 and GMTs and hSBA titres =1:4 and =1:8 and GMTs for each of the four serogroups. Safety •To describe serious adverse events (SAEs) related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) up to each yearly visit in the current study in a retrospective manner.;Primary end point(s): • Persistence of antibodies with respect to components of the investigational vaccine, 2, 3, 4, 5, 6 years after booster vaccination: - rSBA-MenA titres =1:8. - rSBA-MenC titres =1:8. - rSBA-MenW-135 titres =1:8. - rSBA-MenY titres =1:8.;Timepoint(s) of evaluation of this end point: Primary vaccination for 12 to 23 Months, and then a booster vaccination 4 years after that and then 6 years persistence

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Persistence: 2, 3, 4, 5, 6 years after booster vaccination. Serious adverse events: Up to each yearly visit.;Secondary end point(s): •Persistence of antibodies with respect to components of the investigational vaccine, 2, 3, 4, 5, 6 years after booster vaccination: - rSBA-MenA titres=1:128 and GMTs. - rSBA-MenC titres = 1:128 and GMTs. - rSBA-MenW-135 titres = 1:128 and GMTs. - rSBA-MenY titres = 1:128 and GMTs. - hSBA-MenA titres = 1:4, = 1:8 and GMTs. - hSBA-MenC titres = 1:4, = 1:8 and GMTs. - hSBA-MenW-135 titres = 1:4, = 1:8 and GMTs. - hSBA-MenY titres = 1:4, = 1:8 and GMTs. •Serious adverse events: - Occurrence of serious adverse events related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) up to each yearly visit in the current study in a retrospective manner.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Persistence: 2, 3, 4, 5, 6 years after booster vaccination. Serious adverse events: Up to each yearly visit.;Secondary end point(s): •Persistence of antibodies with respect to components of the investigational vaccine, 2, 3, 4, 5, 6 years after booster vaccination: - rSBA-MenA titres=1:128 and GMTs. - rSBA-MenC titres = 1:128 and GMTs. - rSBA-MenW-135 titres = 1:128 and GMTs. - rSBA-MenY titres = 1:128 and GMTs. - hSBA-MenA titres = 1:4, = 1:8 and GMTs. - hSBA-MenC titres = 1:4, = 1:8 and GMTs. - hSBA-MenW-135 titres = 1:4, = 1:8 and GMTs. - hSBA-MenY titres = 1:4, = 1:8 and GMTs. •Serious adverse events: - Occurrence of serious adverse events related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) up to each yearly visit in the current study in a retrospective manner.

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Countries

Finland

Contacts

Public ContactClinical Trials.gov Call Centre

Pfizer Inc

ClinicalTrials.govCallCentre@pfizer.com+18007181021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026