Phase 2
N=407
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
Haemophilus Influenzae Type b · Neisseria Meningitidis
Bottom Line
View on ClinicalTrials.gov: NCT00127855 ↗Enrolled (actual)
407
Serious AEs
5.4%
Results posted
Jul 2012
Primary outcome: Primary: Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter — 72; 75; 65; 66 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hib-MenCY-TT vaccine (MenHibrix) (Biological); Meningitec® (Biological); ActHIB® (Biological); Infanrix® Penta (Biological); Prevenar® (Biological); Mencevax® ACWY (Biological); PRP (Polyribosyl Ribitol Phosphate) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter |
72; 75; 65; 66; 70 | — |
| PRIMARY Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 |
2; 6; 2; 3; 1; 67 | — |
| PRIMARY Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8 |
66; 68; 68; 10; 12 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 |
2; 6; 2; 3; 1; 67 | — |
| SECONDARY Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers |
4.3; 5.2; 4.2; 4.2; 4.1; 1293.1 | — |
| SECONDARY Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8 |
4; 7; 5; 9; 4; 61 | — |
| SECONDARY Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers |
4.6; 5.6; 5.1; 6.3; 4.9; 843.5 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL) |
5; 5; 6; 5; 4; 63 | — |
| SECONDARY Anti-polysaccharide C (PSC) Antibody Concentration |
0.17; 0.17; 0.17; 0.17; 0.17; 12.02 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL) |
3; 4; 3; 7; 7; 67 | — |
| SECONDARY Anti-polysaccharide Y (PSY) Antibody Concentration |
0.17; 0.18; 0.17; 0.20; 0.19; 19.22 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values |
29; 37; 41; 32; 37; 74 | — |
| SECONDARY Anti-PRP Antibody Concentration |
0.152; 0.224; 0.214; 0.172; 0.201; 6.441 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-diphtheria Antibodies |
26; 28; 28; 26; 29; 74 | — |
| SECONDARY Anti-diphtheria Antibody Concentrations |
0.090; 0.098; 0.101; 0.090; 0.093; 1.721 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-tetanus Antibodies |
54; 58; 57; 57; 62; 74 | — |
| SECONDARY Anti-tetanus Antibody Concentrations |
0.460; 0.470; 0.501; 0.562; 0.533; 3.301 | — |
| SECONDARY Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies |
34; 28; 38; 44; 31; 74 | — |
| SECONDARY Anti- FHA Antibody Concentrations |
5.1; 4.6; 5.8; 7.4; 4.8; 137.2 | — |
| SECONDARY Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies |
20; 26; 25; 30; 26; 74 | — |
| SECONDARY Anti-PRN Antibody Concentrations |
3.9; 4.7; 4.6; 5.3; 4.4; 128.3 | — |
| SECONDARY Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies |
5; 6; 5; 11; 3; 74 | — |
| SECONDARY Anti- PT Antibody Concentrations |
2.7; 2.7; 2.8; 3.1; 2.7; 55.1 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies |
15; 16; 12; 14; 22; 71 | — |
| SECONDARY Anti- HBs Antibody Concentrations |
13.7; 12.2; 10.0; 10.1; 18.8; 1769.2 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies |
45; 50; 44; 49; 45; 62 | — |
| SECONDARY Anti-poliovirus Types 1, 2 and 3 Antibody Titers |
36.7; 33.3; 32.9; 52.3; 36.6; 669.6 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values |
10; 9; 10; 11; 10; 69 | — |
| SECONDARY Anti-pneumococcal Antibody Concentrations |
0.036; 0.035; 0.040; 0.034; 0.036; 2.101 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course |
54; 50; 53; 66; 60; 67 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose |
19; 15; 18; 17; 16; 39 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course |
64; 68; 56; 58; 68 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose |
39; 46; 47; 50; 52 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course |
5; 5; 2; 4; 6 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose |
0; 0; 0; 0; 2 | — |
Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.
Eligibility Criteria
Inclusion criteria
- A male or female between, and including, 6 and 12 weeks (42-90 days) 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.
- Vaccinated against hepatitis B at birth.
- Born after a gestation period of 36 - 42 weeks.
Exclusion criteria
- Use of any investigational or non-registered 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 of immunosuppressants or other immune-modifying drugs since birth
- Any chronic drug therapy to be continued during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
- Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
- History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00127855). 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.