Phase 3
Completed N=184
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Infections, Meningococcal
Source: ClinicalTrials.gov NCT01900899 ↗
Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination — 98.4; 23.8; 97.6; 100.0 percentage of participants
◆ Published Evidence
Emerging
5citations · ~1 / year
Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children.
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.
Linked Publications
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Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination |
98.4; 23.8; 97.6; 100.0; 96.7; 9.5 | — |
| PRIMARY Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination |
95.6; 18.2; 88.1; 77.3; 97.8; 9.1 | — |
| PRIMARY Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination |
95.0; 26.1; 88.5; 100.0; 87.0; 17.4 | — |
| PRIMARY Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination |
89.8; 0.0; 80.3; 78.3; 88.3; 13.0 | — |
| PRIMARY Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination |
92.5; 8.7; 71.6; 65.2; 85.8; 13.0 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups |
95.1; 14.3; 74.8; 85.7; 94.3; 9.5 | — |
| SECONDARY Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups |
1071.2; 9.1; 174.5; 224.3; 859.9; 6.6 | — |
| SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups |
70.0; 14.3; 100.0; 100.0; 100.0; 15.0 | — |
| SECONDARY Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups |
33.2; 2.9; 510.08; 424.9; 991.3; 3.4 | — |
Eligibility 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01900899) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.