Phase 2
N=1,103
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Neisseria Meningitidis · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00134719 ↗Enrolled (actual)
1,103
Serious AEs
8.3%
Results posted
Jul 2012
Primary outcome: Primary: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) — 255; 76 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MenHibrix (Hib-MenCY-TT) (Biological); Infanrix® Penta (Biological); Prevenar® (Biological); ActHIB® (Biological); Meningitec® (Biological); M-M-R®II (Biological); Varivax® (Biological); PedvaxHIB® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) |
255; 76 | — |
| PRIMARY Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 |
271; 95 | — |
| PRIMARY Number of Subjects Seroconverted for Anti-measles Antibodies |
815; 274 | — |
| PRIMARY Number of Subjects Seroconverted for Anti-mumps Antibodies |
595; 191 | — |
| PRIMARY Number of Subjects With an Anti-rubella Seroresponse |
848; 284 | — |
| PRIMARY Number of Subjects Seroconverted for Anti-varicella Antibodies |
722; 223 | — |
| SECONDARY Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values |
282; 97; 2; 284; 99; 5 | — |
| SECONDARY rSBA-MenC Titers |
356.9; 714.5; 4.2; 804.6; 790.1; 4.5 | — |
| SECONDARY Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values |
289; 10; 13; 287; 16; 22 | — |
| SECONDARY rSBA-MenY Titers |
315.6; 5.4; 5.9; 728.3; 7.1; 7.7 | — |
| SECONDARY Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values |
85; 29; 0; 83; 28; 0 | — |
| SECONDARY hSBA-MenC Titers |
179.4; 319.0; 2.0; 379.4; 254.2; 2.0 | — |
| SECONDARY Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values |
79; 0; 0; 85; 0; 0 | — |
| SECONDARY hSBA-MenY Titers |
25.6; 2.0; 2.0; 86.4; 2.0; 2.0 | — |
| SECONDARY Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values |
296; 95; 7; 276; 95; 3 | — |
| SECONDARY Anti-PSC Concentrations |
4.32; 3.54; 0.17; 4.15; 3.94; 0.16 | — |
| SECONDARY Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values |
291; 3; 6; 269; 3; 4 | — |
| SECONDARY Anti-PSY Concentrations |
7.81; 0.16; 0.17; 12.92; 0.15; 0.16 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values |
255; 77; 70; 265; 85; 88 | — |
| SECONDARY Anti-PRP Concentrations |
1.320; 0.788; 0.861; 8.551; 3.692; 5.014 | — |
| SECONDARY Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL |
0; 1; 0; 510; 173; 170 | — |
| SECONDARY Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 |
179; 59; 52; 505; 169; 163 | — |
| SECONDARY Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL |
2; 1; 0; 540; 184; 177 | — |
| SECONDARY Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 |
126; 44; 56; 547; 183; 179 | — |
| SECONDARY Number of Subjects With a Fourth Dose Response for hSBA-MenC |
100; 23; 1 | — |
| SECONDARY Number of Subjects With a Fourth Dose Response for hSBA-MenY |
75; 6; 16 | — |
| SECONDARY Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects |
469; 164; 163; 466; 163; 162 | — |
| SECONDARY Anti-measles Concentrations in Initially Seronegative Subjects |
1627.494; 1773.293; 1786.404 | — |
| SECONDARY Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects |
500; 174; 171; 498; 173; 171 | — |
| SECONDARY Anti-rubella Concentrations in Initially Seronegative Subjects |
78.779; 83.168; 76.691 | — |
| SECONDARY Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination |
330; 115; 110 | — |
| SECONDARY Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects |
293; 98; 102; 265; 92; 93 | — |
| SECONDARY Anti-mumps Titers in Initially Seronegative Subjects |
120.777; 145.405; 115.279 | — |
| SECONDARY Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects |
403; 136; 119; 403; 136; 119 | — |
| SECONDARY Anti-varicella Titers in Initially Seronegative Subjects |
414.633; 468.985; 438.280 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase |
432; 171; 152; 556; 189; 189 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase |
217; 60; 100; 379; 102; 157 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events |
490; 166; 158; 429; 139; 147 | — |
| SECONDARY Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine |
324; 107; 112; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase |
176; 67; 51; 124; 39; 36 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase |
52; 15; 13; 20; 8; 5 | — |
Summary
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Eligibility Criteria
Inclusion Criteria
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A 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 into the study.
- Born after a gestation period between 36 and 42 weeks.
Exclusion Criteria
- 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 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. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive 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, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin.
- 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.
- Additional specific criteria for the booster part of the study
- History of or previous vaccination against measles, mumps, rubella or varicella.
- Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
Data sourced from ClinicalTrials.gov (NCT00134719). 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.