Phase 2
N=388
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Haemophilus Influenzae Type b · Neisseria Meningitidis
Bottom Line
View on ClinicalTrials.gov: NCT00129116 ↗Enrolled (actual)
388
Serious AEs
2.1%
Results posted
Jul 2012
Primary outcome: Primary: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). — 66; 66; 69; 73 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hib-MenCY-TT vaccine (Biological); Hib-MenC-TT vaccine (Biological); Menjugate ® (Biological); Infanrix penta ® (Biological); Infanrix hexa ® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
26; 28; 27; 32; 11 | — |
| PRIMARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
38; 38; 38; 39; 36 | — |
| PRIMARY Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
35; 31; 36; 11; 15 | — |
| PRIMARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
26; 28; 27; 32; 11 | — |
| PRIMARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
38; 38; 38; 39; 36 | — |
| PRIMARY Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
35; 31; 36; 11; 15 | — |
| SECONDARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
38; 38; 38; 39; 36 | — |
| SECONDARY Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
35; 31; 36; 11; 15 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
26; 28; 27; 32; 11 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). |
26; 28; 27; 32; 11 | — |
| SECONDARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8 |
38; 38; 38; 39; 36 | — |
| SECONDARY Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8 |
35; 31; 36; 11; 15 | — |
| SECONDARY rSBA-MenC Antibody Titres |
128.0; 144.2; 125.8; 150.6; 195.5; 4762.6 | — |
| SECONDARY rSBA-MenY Antibody Titres |
97.2; 64.0; 100.9; 11.0; 16.1; 1708.1 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). |
39; 38; 42; 42; 36; 39 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
1.306; 1.591; 1.414; 1.764; 0.607; 36.280 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) |
38; 38; 40; 40; 38; 33 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) |
7; 6; 12; 15; 12; 69 | — |
| SECONDARY Anti-PSC Antibody Concentrations |
2.57; 3.23; 2.53; 3.08; 3.17; 32.04 | — |
| SECONDARY Anti-PSY Antibody Concentrations |
3.72; 5.25; 3.96; 0.16; NA; 26.15 | — |
| SECONDARY Anti-tetanus Antibody Concentrations |
0.433; 0.485; 0.523; 0.436; 0.379; 3.057 | — |
| SECONDARY Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations |
3.4; 3.1; 3.7; 3.3; 3.1; 53.9 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-tetanus Antibodies |
58; 57; 60; 63; 61; 68 | — |
| SECONDARY Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL) |
15; 11; 18; 12; 9; 67 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL). |
39; 38; 42; 42; 36; 39 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
1.306; 1.591; 1.414; 1.764; 0.607; 36.280 | — |
| SECONDARY Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128 |
25; 24; 22; 27; 26; 40 | — |
| SECONDARY Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128 |
24; 18; 23; 6; 7; 40 | — |
| SECONDARY rSBA-MenC Antibody Titres |
128.0; 144.2; 125.8; 150.6; 195.5; 4762.6 | — |
| SECONDARY rSBA-MenY Antibody Titres |
97.2; 64.0; 100.9; 11.0; 16.1; 1708.1 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL) |
38; 38; 40; 40; 38; 33 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL) |
24; 30; 28; 26; 27; 33 | — |
| SECONDARY Anti-PSC Antibody Concentrations |
2.57; 3.23; 2.53; 3.08; 3.17; 32.04 | — |
| SECONDARY Anti-PSY Antibody Concentrations |
3.72; 5.25; 3.96; 0.16; NA; 26.15 | — |
| SECONDARY Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL). |
41; 39; 42; 42; 37; 39 | — |
| SECONDARY Anti-T Antibody Concentrations |
0.836; 0.986; 0.894; 0.839; 0.322; 12.609 | — |
| SECONDARY Anti-diphtheria Antibody Concentrations |
1.016; 0.927; 0.980; 1.012; 1.904 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations |
377.9; 397.0; 408.9; 520.5; 287.3 | — |
| SECONDARY Anti-poliovirus Types 1, 2, 3 Antibody Titres |
275.5; 242.0; 216.8; 305.2; 282.6; 155.8 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-diphtheria Antibodies |
66; 64; 69; 74; 69 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-hepatitis B Antibodies |
60; 60; 66; 70; 61 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies |
57; 55; 56; 61; 55; 55 | — |
| SECONDARY Number of Subjects With Vaccine Response to PT, FHA and PRN |
63; 58; 64; 66; 68; 65 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
5; 10; 8; 8; 9; 20 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
14; 18; 18; 17; 18; 16 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
7; 12; 13; 12; 11 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
1; 1; 0; 1; 0 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
5; 10; 8; 8; 9; 20 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
14; 18; 18; 17; 18; 16 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
7; 12; 13; 12; 11 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
1; 1; 0; 1; 0 | — |
Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Eligibility Criteria
Inclusion Criteria
- Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
Exclusion Criteria
- Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Data sourced from ClinicalTrials.gov (NCT00129116). 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.