Phase 3
Completed N=750
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Meningococcal Infection
Source: ClinicalTrials.gov NCT01340898 ↗
Enrolled (actual)
750
Serious AEs
8.4%
Results posted
Aug 2019
Primary outcomePrimary: Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group — 328; 327; 325; 327 Participants
◆ Published Evidence
Emerging
19citations · ~2 / year
Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study.
Summary
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
Linked Publications
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Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group |
328; 327; 325; 327 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group |
225; 283; 190; 282; 225; 284 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group |
321; 146; 282; 318; 93; 282 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group |
577.5; 71.1; 2366.4; 803.1; 33.9; 2761.2 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups |
161; 6; 107; 19; 138; 133 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups |
1332.9; 4.8; 125.3; 7.2; 2762.3; 2918.7 | — |
| SECONDARY Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group |
248; 108; 125; 270; 129; 126 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups) |
136; 58; 9; 147; 66; 3 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups |
808.0; 270.5; 2.6; 3970.8; 523.1; 2.3 | — |
| SECONDARY Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) |
131; 48; 18; 173; 83; 70 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control) |
64.6; 20.8; 3.2; 2318.6; 1415.6; 196.3 | — |
| SECONDARY Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group |
130; 61; 51; 163; 73; 65 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL). |
82; 42; 37; 36; 19; 19 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL) |
76; 41; 34; 12; 5; 8 | — |
| SECONDARY Anti-pneumococcal Antibody Concentrations |
1.3; 1.4; 1.5; 0.2; 0.2; 0.2 | — |
| SECONDARY Number of Subjects With Anti-diphtheria (Anti-D) Antibodies |
72; 34; 38 | — |
| SECONDARY Concentration of Antibodies Against Diphtheria Antigens (Anti-D) |
2.435; 3.069; 2.423 | — |
| SECONDARY Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens |
50.4; 54.7; 46.4; 127.3; 143.3; 129.4 | — |
| SECONDARY Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies |
77; 36; 40; 77; 36; 40 | — |
| SECONDARY Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies |
827.2; 1048.1; 861.0; 931.3; 990.4; 1024.0 | — |
| SECONDARY Number of Subjects With Anti-tetanus (Anti-T) Antibodies |
77; 36; 40; 58; 28; 24 | — |
| SECONDARY Concentration of Antibodies Against Tetanus Antigens (Anti-T) |
5.798; 7.246; 5.973; 0.479; 0.659; 0.461 | — |
| SECONDARY Anti-PRP Antibody Concentrations (Geometric Mean Concentrations) in a Randomized Subset of 25% of the Subjects |
— | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms (Primary Phase) |
220; 115; 108; 38; 25; 14 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms (Booster Phase) |
139; 71; 77; 21; 19; 14 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms (Primary Phase) |
177; 93; 84; 18; 10; 2 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms (Booster Phase) |
79; 46; 43; 4; 7; 5 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase) |
67; 36; 34; 70; 34; 28 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase) |
58; 32; 36 | — |
| SECONDARY Number of Subjects With New Onset of Chronic Illnesses (NOCIs) |
16; 8; 4 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
35; 14; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
Exclusion Criteria
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Extended administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine.
- Concurrently participating 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.
- Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia.
- History of receipt of meningococcal vaccine.
- Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine.
- History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of th
Data sourced from ClinicalTrials.gov (NCT01340898) and the linked publication. 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.