Phase 3
Completed N=793
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00508261 ↗
Enrolled (actual)
793
Serious AEs
4.4%
Results posted
Jan 2019
Primary outcomePrimary: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. — 193; 180; 191; 178 Participants
◆ Published Evidence
Established
68citations · ~5 / year
An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children.
Summary
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Linked Publications
-
An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. |
193; 180; 191; 178; 193; 183 | — |
| PRIMARY Anti-PT, Anti-FHA and Anti-PRN Concentrations |
86; 85; 542; 544; 470; 450 | — |
| PRIMARY Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off |
180; 166 | — |
| PRIMARY Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off |
183; 170 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values |
30; 32; 34; 18; 193; 180 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers |
15; 19; 24; 15.9; 3152.9; 3169.9 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off |
4; 1; 1; 1; 46; 45 | — |
| SECONDARY Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
0.17; 0.15; 0.16; 0.16; 31.01; 33.15 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT) |
177; 161; 155; 99; 184; 177 | — |
| SECONDARY Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations |
0.481; 0.39; 0.416; 0.393; 10.47; 7.941 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off |
169; 157; 154; 94; 184; 156 | — |
| SECONDARY Anti-diphtheria (Anti-D) Antibody Concentrations |
0.477; 0.476; 0.437; 0.452; 7.636; 0.404 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off |
158; 143; 142; 90; 166; 149 | — |
| SECONDARY Anti-polio Type 1, 2 & 3 Titers |
84.2; 72.5; 83.6; 71.7; 984.4; 74.2 | — |
| SECONDARY Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off |
73; 64; 65; 34; 183; 70 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
0.806; 0.665; 0.766; 0.585; 25.556; 0.711 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs |
173; 158; 155; 95; 180; 160 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
111.6; 92.8; 101.2; 85.6; 2048.4; 95 | — |
| SECONDARY Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens |
180; 169; 163; 184; 159; 158 | — |
| SECONDARY Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations |
11; 10; 10; 11; 86; 8 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination |
49; 30; 35; 16; 3; 0 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination |
60; 65; 64; 6; 5; 10 | — |
| SECONDARY Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose |
85; 56; 80; 29; 80; 41 | — |
| SECONDARY Number of Subjects Reporting Any Rash |
13; 25; 22; 12 | — |
| SECONDARY Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) |
1; 2; 6; 1 | — |
| SECONDARY Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER) |
5; 3; 14; 6 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose |
71; 81; 83; 42 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose |
87; 79 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
10; 8; 11; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, 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 first vaccine dose.
- Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Additional criteria for subjects receiving Infanrix hexa™
- Hypersensitivity reaction due to previous vaccination with Infanrix hexa™.
- Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
Data sourced from ClinicalTrials.gov (NCT00508261) 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.