Phase 3
Completed N=1,554
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00614614 ↗
Enrolled (actual)
1,554
Serious AEs
3.8%
Results posted
Jul 2012
Primary outcomePrimary: Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group — 254; 286; 270; 291 Participants
Summary
The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group |
254; 286; 270; 291 | — |
| PRIMARY Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group |
248; 293; 279; 303 | — |
| PRIMARY Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group |
3845.0; 4800.9 | — |
| PRIMARY Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group |
67.6; 142.3 | — |
| PRIMARY Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group |
146; 253; 145; 253 | — |
| PRIMARY Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group |
2676.1; 2227.7 | — |
| PRIMARY Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group |
155; 157 | — |
| PRIMARY Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group |
91.0; 67.7; 422.9; 353.2; 315.1; 189.2 | — |
| SECONDARY Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group |
286; 155; 291; 157 | — |
| SECONDARY Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group |
256; 270 | — |
| SECONDARY Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group |
94.8; 923.9 | — |
| SECONDARY Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group |
67.6; 142.3 | — |
| SECONDARY Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group |
243; 241; 258; 258 | — |
| SECONDARY Anti-D and Anti-T Geometric Mean Antibody Concentrations |
8.259; 7.214; 7.360; 7.458; 5.500; 7.400 | — |
| SECONDARY Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value |
146; 252; 132; 254; 146; 252 | — |
| SECONDARY Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value |
146; 252; 130; 254; 146; 252 | — |
| SECONDARY Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group |
73.3; 86.9; 321.6; 371.7; 203.8; 220.2 | — |
| SECONDARY Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group |
250; 132; 250; 132 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group |
253; 293; 279; 303 | — |
| SECONDARY Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group |
92.4; 1582.9 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine |
156; 104; 170; 7; 4; 2 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase |
79; 171; 97; 161; 1; 7 | — |
| SECONDARY Number of Subjects Reporting Any Rash |
40; 93; 54; 83 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine |
99; 145; 99; 156; 4; 5 | — |
| SECONDARY Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits |
128; 29; 293; 55 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination |
101; 194; 105; 182 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination |
167; 79 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
2; 15; 3; 9; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after 36 weeks gestation.
- For inclusion in the booster phase, subjects must have received all three doses in the primary phase.
Exclusion Criteria
Exclusion criteria for enrolment (primary phase)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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 since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrent participation 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 product (pharmaceutical product or device).
Exclusion criteria for enrolment (booster phase)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
- Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
- Previous administration of a booster dose of Hib prior to entry to the booster phase.
- Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
- Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
- Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
- History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration duri
Data sourced from ClinicalTrials.gov (NCT00614614). 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.