Phase 3
Completed N=243
The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination
Infections, Meningococcal
Source: ClinicalTrials.gov NCT01962207 ↗
Enrolled (actual)
243
Serious AEs
0.2%
Results posted
Jun 2019
Primary outcomePrimary: Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination — 51.9; 18.8; 79.6; 12.5 percentage of participants
◆ Published Evidence
Emerging
15citations · ~3 / year
Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age.
Summary
The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.
Linked Publications
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Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination |
51.9; 18.8; 79.6; 12.5; 77.8; 75.0 | — |
| PRIMARY Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination |
58.3; 9.5; 74.0; 18.5; 78.3; 71.4 | — |
| PRIMARY Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination |
47.7; 4.5; 70.0; 24.0; 78.5; 77.3 | — |
| PRIMARY Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination |
67.2; 4.8; 79.6; 24.0; 81.3; 85.7 | — |
| PRIMARY Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination |
65.6; 17.6; 88.9; 28.6; 82.8; 88.2 | — |
| PRIMARY Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination |
16.0; 5.9; 107.3; 5.8; 161.3; 103.1 | — |
| PRIMARY Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination |
20.4; 6.1; 65.3; 7.4; 104.0; 54.3 | — |
| PRIMARY Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination |
15.8; 4.8; 51.3; 7.8; 110.2; 64.0 | — |
| PRIMARY Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination |
28.4; 5.2; 118.8; 10.9; 166.0; 92.0 | — |
| PRIMARY Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination |
29.3; 5.8; 106.0; 9.1; 132.2; 81.7 | — |
| SECONDARY Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination |
34.1; 28.6; 42.2; 42.9; 26.7; 14.3 | — |
| SECONDARY Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination |
4.7; 3.5; 6.5; 5.9; 3.8; 2.8 | — |
| SECONDARY Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination |
98.4; 100.0; 95.9; 100.0; 100.0; 100.0 | — |
| SECONDARY Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination |
5122.3; 4871.0; 4626.4; 6414.2; 7163.5; 5792.6 | — |
| SECONDARY Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination |
90.3; 100.0; 87.7; 94.1; 82.3; 93.8 | — |
| SECONDARY Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination |
100.0; 87.5; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination |
1534.2; 90.0; 1213.0; 211.1; 33959.8; 42559.2 | — |
| SECONDARY Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination |
98.3; 93.3; 100.0; 88.2; 86.0; 92.9 | — |
| SECONDARY Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination |
59.7; 56.3; 59.5; 61.9; 43.3; 37.5 | — |
| SECONDARY Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination |
23.9; 31.3; 35.1; 52.4 | — |
| SECONDARY Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination |
0.0; 0.0; 1.3; 0.0 | — |
| SECONDARY Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination |
0.0; 0.0; 1.3; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female who has received a primary vaccination with the MenACWY-TT, Meningitec or Mencevax ACWY vaccines in study MenACWY-TT-027 (NCT00427908).
- In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 15 years of age, or written informed consent obtained from the subject if the subject has achieved the 15th birthday. The subjects ≥15 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
- Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
All subjects must satisfy the following additional criteria prior to entry of the booster phase:
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, hysterectomy or bilateral ovariectomy.
- Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk of pregnancy may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination (for females only), and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.
Exclusion Criteria
- Child in care.
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MenACWY-TT-027.
Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e. MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be followed for the persistence of MenA, MenW-135 and MenY.
- History of meningococcal disease due to serogroup A, C, W-135 or Y.
- Previous vaccination with meningococcal B vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of chronic alcohol consumption and/or drug abuse.
- Subjects who withdrew consent to be contacted for follow-up studies.
Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at Month 126) for all subjects:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
- Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination, with the exception of a licensed inactivated influenza vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
Data sourced from ClinicalTrials.gov (NCT01962207) 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.