Phase 2
N=756
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Haemophilus Influenzae Type b · Neisseria Meningitidis
Bottom Line
View on ClinicalTrials.gov: NCT00129129 ↗Enrolled (actual)
756
Serious AEs
3.8%
Results posted
Dec 2013
Primary outcome: Primary: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. — 186; 181 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine (Biological); ActHIB (Biological); Pediarix (Biological); Prevnar (Biological); Menomune (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. |
186; 181 | — |
| PRIMARY Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes |
1.72; 1.9; 1.31; 1.59; 2.17; 2.32 | — |
| PRIMARY Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations |
57.1; 66.4; 208.9; 252.2; 86.3; 93.8 | — |
| PRIMARY Number of Subjects Reporting Any Grade 3 Symptoms |
33; 79 | — |
| PRIMARY Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value |
174; 92 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values |
10; 13; 27; 3; 5; 20 | — |
| SECONDARY Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers |
4.8; 5.1; 9; 1096.5; 4.4; 284.2 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values |
29; 28; 92; 4; 3; 61 | — |
| SECONDARY Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers |
6.1; 5.7; 54.9; 495.3; 6.8; 685.1 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 |
2; 1; 3 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 |
13; 0; 0 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values |
24; 16; 10; 196; 8; 134 | — |
| SECONDARY Anti-polysaccharide C (Anti-PSC) Antibody Concentrations |
0.19; 0.18; 0.17; 4.41; 0.16; 7.37 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values |
23; 28; 6; 188; 5; 125 | — |
| SECONDARY Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations |
0.20; 0.20; 0.17; 19.82; 0.15; 7.21 | — |
| SECONDARY Number of Subjects Reporting Medically Attended Visits |
1; 18 | — |
| SECONDARY Number of Subjects Reporting Rash |
10; 10; 10 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
6; 2; 3 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values |
43; 42; 196; 202; 9; 10 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
1.073; 0.810; 0.695; 28.596; 19.029; 10.650 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off |
1; 0; 162; 168; 10; 8 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off |
1; 0; 162; 168; 10; 8 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off |
1; 0; 162; 168; 10; 8 | — |
| SECONDARY Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) |
81; 89; 201; 219; 109; 130 | — |
| SECONDARY Anti-diphtheria and Anti-tetanus Antibody Concentrations |
0.173; 0.155; 2.060; 2.277; 0.565; 0.497 | — |
| SECONDARY Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) |
28; 27; 167; 166 | — |
| SECONDARY Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations |
13.5; 11.3; 1567.5; 1555.1 | — |
| SECONDARY Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL |
21; 37; 196; 214; 91; 103 | — |
| SECONDARY Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations |
3.4; 3.9; 10.0; 10.5; 4.8; 5.1 | — |
| SECONDARY Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 |
34; 41; 86; 82; 31; 39 | — |
| SECONDARY Anti-poliovirus Types 1, 2 and 3 Antibody Titers |
12.3; 17.3; 530.7; 651.5; 9.4; 13.5 | — |
| SECONDARY Number of Subjects With Vaccine Response to PT, FHA and PRN |
109; 132; 113; 128; 103; 126 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms |
61; 46; 36; 2; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms |
61; 46; 36; 2; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms |
79; 48; 43; 27; 8; 8 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms |
79; 48; 43; 27; 8; 8 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
102; 39; 58 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
6; 2; 3 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
6; 2; 3 | — |
| SECONDARY Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs) |
2; 5 | — |
| SECONDARY Number of Subjects Reporting Rash |
10; 10; 10 | — |
| SECONDARY Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses |
25; 31; 181; 190; 51; 46 | — |
| SECONDARY Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) |
140; 2; 71; 134; 11; 78 | — |
| SECONDARY Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) |
140; 2; 71; 134; 11; 78 | — |
| SECONDARY Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) |
52; 0; 29; 56; 1; 15 | — |
| SECONDARY Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) |
52; 0; 29; 56; 1; 15 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) |
174; 89; 102; 174; 89; 101 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) |
174; 89; 102; 174; 89; 101 | — |
| SECONDARY Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) |
165; 86; 99; 171; 89; 100 | — |
| SECONDARY Concentration of Antibodies Against Streptococcus Pneumonia Serotypes |
2.38; 2.69; 2.92; 3.91; 4.07; 5.04 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values |
152; 78; 85; 176; 93; 103 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
1.073; 0.810; 0.695; 28.596; 19.029; 10.650 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values |
147; 5; 9; 161; 8; 90 | — |
| SECONDARY rSBA-MenC Antibody Titers |
167.1; 4.7; 5.3; 2443.9; 5.3; 321.8 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values |
142; 26; 37; 160; 30; 93 | — |
| SECONDARY rSBA-MenY Antibody Titers |
128.6; 11.3; 15.6; 1424.6; 16.1; 1454.0 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values |
54; 0; 1; 63; 1; 33 | — |
| SECONDARY hSBA-MenC Antibody Titers |
68.1; NA; 2.0; 657.1; 2.1; 72.5 | — |
| SECONDARY Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values |
33; 0; 0; 62; 1; 21 | — |
| SECONDARY hSBA-MenY Antibody Titers |
11.3; NA; NA; 246.6; 2.2; 11.1 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values |
150; 3; 5; 173; 3; 104 | — |
| SECONDARY Anti-PSC Antibody Concentrations |
0.88; 0.16; 0.16; 4.32; 0.16; 6.81 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values |
155; 1; 0; 172; 3; 101 | — |
| SECONDARY Anti-PSY Antibody Concentrations |
3.83; 0.15; NA; 22.27; 0.16; 5.57 | — |
| SECONDARY Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) |
164; 89; 93; 178; 95; 104 | — |
| SECONDARY Anti-tetanus Antibody Concentrations |
0.782; 0.461; 0.488; 2.559; 1.785; 1.794 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms |
61; 46; 36; 2; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms |
61; 46; 36; 2; 5; 5 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms |
79; 48; 43; 27; 8; 8 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms |
79; 48; 43; 27; 8; 8 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
102; 39; 58 | — |
| SECONDARY Number of Subjects Reporting New Onset of Chronic Illness(es) |
2; 1; 0 | — |
| SECONDARY Number of Subjects Reporting Rash |
10; 10; 10 | — |
| SECONDARY Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses |
6; 1; 7; 75; 31; 43 | — |
| SECONDARY Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) |
3; 0; 0; 3; 0; 0 | — |
Summary
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
Eligibility Criteria
Inclusion Criteria
- For Groups A and B
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy male or female between, and including, 6 and 12 weeks 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 the study.
- Born after a gestation period between 36 and 42 weeks.
- Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
- For Group C
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- Healthy male or female between, and including, 3 and 5 years 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 the study.
Exclusion Criteria
-For Groups A and B
- 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 within six months prior to the first vaccine dose.
- 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, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.
- 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 vaccine(s), including 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.
For Group C
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
- Previous vaccination against Neisseria meningitidis.
- History of Neisseria meningitidis disease.
- 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 vaccine, including dry natural latex rubber
- Major congenital defects or serious chronic illness.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00129129). 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.