Phase 3
Completed N=271
Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children
Infections, Meningococcal · Meningococcal Vaccines
Source: ClinicalTrials.gov NCT01266993 ↗
Enrolled (actual)
271
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. — 167; 15; 124; 53 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®.
This protocol posting deals with objectives & outcome measures of the persistence and booster epochs. The objectives & outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. |
167; 15; 124; 53; 149; 5 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. |
162; 17; 70; 30; 129; 7 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. |
161; 19; 110; 42; 145; 17 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. |
154; 18; 71; 38; 94; 9 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. |
140; 9; 69; 35; 136; 5 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. |
151; 16; 38; 23; 120; 5 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. |
107; 10; 65; 32; 123; 10 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. |
107; 12; 38; 25; 84; 8 | — |
| SECONDARY Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. |
196.3; 8; 34.8; 86.5; 213.9; 5.6 | — |
| SECONDARY Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. |
307.5; 13.5; 14.5; 31; 103.5; 5.9 | — |
| SECONDARY Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. |
120.1; 9.8; 30.5; 69.0; 158.3; 10.3 | — |
| SECONDARY Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. |
129.5; 11.1; 14.2; 44.5; 59.2; 7.8 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. |
24; 5; 86; 30; 73; 4 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. |
26; 5; 63; 20; 70; 8 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. |
53; 19; 66; 21; 69; 13 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. |
70; 23; 134; 43; 125; 19 | — |
| SECONDARY Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. |
4.6; 2.7; 75.9; 82.2; 69.9; 3.8 | — |
| SECONDARY Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. |
4.8; 2.8; 36.4; 38.8; 64.3; 5.2 | — |
| SECONDARY Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. |
10.6; 7.6; 20.6; 31.2; 59.3; 9.2 | — |
| SECONDARY Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. |
6.9; 4.5; 28.4; 34.3; 56.7; 8.1 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. |
165; 55; 165; 55; 165; 55 | — |
| SECONDARY Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY |
5613.0; 3521.1; 5314.6; 7042.2; 14750.6; 10540.4 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. |
163; 46; 161; 54; 156; 50 | — |
| SECONDARY Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY |
1376.5; 101.2; 11986.8; 13692.2; 14582.1; 235.7 | — |
| SECONDARY Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies |
147; 54; 161; 48; 157; 54 | — |
| SECONDARY Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies |
156; 43; 153; 46; 136; 34 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
113; 35; 7; 4; 62; 25 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Solicited General Symptoms |
38; 12; 3; 0; 28; 10 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
26; 8 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) |
0; 0 | — |
| SECONDARY Number of Subjects With Serious Adverse Events SAEs |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study (NCT number = NCT00674583).
- Written informed consent obtained from the parent(s)/Legally Acceptable Representatives(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
All subjects must meet the additional following criteria prior to receiving the booster vaccination:
- Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential 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, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria
- Child in care.
- Use of any investigational or non-registered product within 30 days preceding the first persistence blood sample or planned use within 30 days preceding a blood sample during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed).
- Concurrently participating in another clinical study or planned participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product within 30 days of a blood sample.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
- Serious chronic illness.
- Administration of immunoglobulins and/or blood products within the 3 months preceding the subject's first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
- Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.
Exclusion criteria for booster vaccination to be checked at Visit 4 (Month 68)
- Child in care.
- Use of any investigational or non-registered product within 30 days preceding the booster vaccination or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed).
- Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the study period.
- Concurrently participating in a
Data sourced from ClinicalTrials.gov (NCT01266993). 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.