A Phase 3 interventional study of Meningococcal vaccine GSK 134612 and SynflorixTM in Meningococcal Infection, sponsored by GlaxoSmithKline. Completed at 2 sites in 2 countries. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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Among 71 studies in Meningococcal Infections by GlaxoSmithKline — none open to participants now, 1 under way, none of them phase 3. Meningococcal Infections · GlaxoSmithKline.
Among the 71 studies in Meningococcal Infections by GlaxoSmithKline, this one is the 26th largest by enrollment of the 67 interventional ones that give a count, is one of 3 that started in 2012, is one of 34 in phase 3, and was the 41st registered.
243 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.
Browse Meningococcal Infections studies →None of the 71 studies in Meningococcal Infections by GlaxoSmithKline is open now. The open studies under Meningococcal Infections, anywhere →
Of the 7 Meningococcal Infections studies recruiting now, 3 set no upper age limit and 4 stop at 75 or younger; 4 take children under 18; 6 take healthy volunteers.
This study: 6 Weeks to 12 Weeks · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
71 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 26 · Phase 3 34 · Phase 4 6
First in 2002; this study’s year is marked. 3 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 753 is above the median of 456 across 214 interventional studies indexed under Meningococcal Infections.
Median enrollment 613 across the 67 interventional studies, 119 across the 4 observational. Of the 70 that completed or were terminated, 60 (86%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 71 studies in Meningococcal Infections by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects, male and female, received 4 doses of Nimenrix™ vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Biological: Meningococcal vaccine GSK 134612 · Biological: SynflorixTM · Biological: Infanrix-IPV/HiberixTM
Subjects, male and female, received 2 doses of Nimenrix™ vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Biological: Meningococcal vaccine GSK 134612 · Biological: SynflorixTM · Biological: Infanrix-IPV/HiberixTM
Subjects, male and female, received 1 dose of Nimenrix™ at 15-18 months of age and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.
Biological: Meningococcal vaccine GSK 134612 · Biological: SynflorixTM · Biological: Infanrix-IPV/HiberixTM
Intramuscular injection
Intramuscular injection
Intramuscular injection
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
The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.
Time frame: At Month 5 (one month post-dose 3)
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
The cut-off value for the rSBA titers was ≥ 1:8
Time frame: At Month 13 (prior booster) and at Month 14 (one month after the booster dose)
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
The cut-off value for the rSBA titers was ≥ 1:128
Time frame: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
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
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
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
The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128
Time frame: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
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
Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers \< 1:8 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers \>= 1:8 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination antibody titer.
Time frame: At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
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)
The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
Time frame: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
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
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
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)
The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
Time frame: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
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)
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
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
Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers \< 1:4 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers \>= 1:4 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination.
Time frame: At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL).
The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL)
The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
Anti-pneumococcal Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL)
Time frame: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
Number of Subjects With Anti-diphtheria (Anti-D) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: At Month 5 (one month post-dose 3)
Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time frame: At Month 5 (one month post-dose 3)
Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
Time frame: At Month 5 (one month post-dose 3)
Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens
Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Time frame: At Month 5 (one month post-dose 3)
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies
Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Time frame: At Month 5 (one month post-dose 3)
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Month 5 (one month post-dose 3)
Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies
Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
Time frame: At Month 5 (one month post-dose 3)
Number of Subjects With Anti-tetanus (Anti-T) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
Concentration of Antibodies Against Tetanus Antigens (Anti-T)
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time frame: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
Number of Subjects With Anti-tetanus (Anti-T) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
Time frame: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
Anti-PRP Antibody Concentrations (Geometric Mean Concentrations) in a Randomized Subset of 25% of the Subjects
The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate \[anti-PRP\] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.
Time frame: At Month 5 (one month post-dose 3)
Number of Subjects With Solicited Local Symptoms (Primary Phase)
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: Within 8 days (Day 0-7) post primary vaccination
Number of Subjects With Solicited Local Symptoms (Booster Phase)
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: Within 8 days (Day 0-7) post booster vaccination
Number of Subjects With Solicited General Symptoms (Primary Phase)
Assessed solicited general symptoms were temperature \[defined as rectally temperature equal to or above 38 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 8 days (Day 0-7) post primary vaccination
Number of Subjects With Solicited General Symptoms (Booster Phase)
Assessed solicited general symptoms were temperature \[defined as rectally temperature equal to or above 38 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 8 days (Day 0-7) post booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 31 days (Day 0-30) post each primary vaccine dose
Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 31 days (Day 0-30) post booster vaccination
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 to Month 19
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 to Month 19
| Milestone | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Started | 376 | 187 | 187 |
| Completed | 360 | 178 | 181 |
| Not completed | 16 | 9 | 6 |
| Withdrew: Serious adverse events | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 8 | 7 | 5 |
| Withdrew: Migrated/moved from study area | 4 | 1 | 0 |
| Withdrew: Lost to follow-up | 4 | 1 | 0 |
| Milestone | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Started | 342 | 166 | 170 |
| Completed | 332 | 164 | 163 |
| Not completed | 10 | 2 | 7 |
| Withdrew: Withdrawal by subject | 3 | 0 | 4 |
| Withdrew: Migrated/moved from study area | 3 | 0 | 0 |
| Withdrew: Lost to follow-up | 4 | 2 | 3 |
The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.
| Participants | Nimenrix 3+1 Group |
|---|---|
| rSBA-MenA | 328 |
| rSBA-MenC | 327 |
| rSBA-MenW-135 | 325 |
| rSBA-MenY | 327 |
The cut-off value for the rSBA titers was ≥ 1:8
| Participants | Nimenrix 3+1 Group |
|---|---|
| rSBA-MenA, M13 | 225 |
| rSBA-MenA, M14 | 283 |
| rSBA-MenC, M13 | 190 |
| rSBA-MenC, M14 | 282 |
| rSBA-MenW-135, M13 | 225 |
| rSBA-MenW-135, M14 | 284 |
| rSBA-MenY, M13 | 240 |
| rSBA-MenY, M14 | 284 |
The cut-off value for the rSBA titers was ≥ 1:128
| Participants | Nimenrix 3+1 Group |
|---|---|
| rSBA-MenA, M5 | 321 |
| rSBA-MenA, M13 | 146 |
| rSBA-MenA, M14 | 282 |
| rSBA-MenC, M5 | 318 |
| rSBA-MenC, M13 | 93 |
| rSBA-MenC, M14 | 282 |
| rSBA-MenW-135, M5 | 313 |
| rSBA-MenW-135, M13 | 122 |
| rSBA-MenW-135, M14 | 284 |
| rSBA-MenY, M5 | 312 |
| rSBA-MenY, M13 | 121 |
| rSBA-MenY, M14 | 283 |
Antibody titers are presented as geometric mean titers (GMTs).
| Titers | Nimenrix 3+1 Group |
|---|---|
| rSBA-MenA, M5 | 577.5 (520.7 to 640.6) |
| rSBA-MenA, M13 | 71.1 (56.6 to 89.3) |
| rSBA-MenA, M14 | 2366.4 (2134.8 to 2623.1) |
| rSBA-MenC, M5 | 803.1 (710.4 to 907.8) |
| rSBA-MenC, M13 | 33.9 (27.4 to 41.9) |
| rSBA-MenC, M14 | 2761.2 (2461.2 to 3097.9) |
| rSBA-MenW-135, M5 | 1190.3 (1019.3 to 1390.1) |
| rSBA-MenW-135, M13 | 52.0 (42.2 to 64.2) |
| rSBA-MenW-135, M14 | 3696.9 (3242.8 to 4214.7) |
| rSBA-MenY, M5 | 647.4 (566.6 to 739.6) |
| rSBA-MenY, M13 | 66.3 (54.3 to 81.0) |
| rSBA-MenY, M14 | 2778.6 (2472.5 to 3122.5) |
The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128
| Participants | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|
| rSBA-MenA, M5, ≥ 1:8 | 161 | 6 |
| rSBA-MenA, M13, ≥ 1:8 | 107 | 19 |
| rSBA-MenA, M14, ≥ 1:8 | 138 | 133 |
| rSBA-MenC, M5, ≥ 1:8 | 162 | 6 |
| rSBA-MenC, M13, ≥ 1:8 | 86 | 3 |
| rSBA-MenC, M14, ≥ 1:8 | 138 | 130 |
| rSBA-MenW-135, M5, ≥ 1:8 | 153 | 4 |
| rSBA-MenW-135, M13, ≥ 1:8 | 102 | 7 |
| rSBA-MenW-135, M14, ≥ 1:8 | 139 | 131 |
| rSBA-MenY, M5, ≥ 1:8 | 161 | 16 |
| rSBA-MenY, M13, ≥ 1:8 | 116 | 24 |
| rSBA-MenY, M14, ≥ 1:8 | 139 | 131 |
| rSBA-MenA, M5, ≥ 1:128 | 155 | 6 |
| rSBA-MenA, M13, ≥ 1:128 | 88 | 16 |
| rSBA-MenA, M14, ≥ 1:128 | 138 | 132 |
| rSBA-MenC, M5, ≥ 1:128 | 151 | 5 |
| rSBA-MenC, M13, ≥ 1:128 | 39 | 1 |
| rSBA-MenC, M14, ≥ 1:128 | 137 | 128 |
| rSBA-MenW-135, M5, ≥ 1:128 | 151 | 4 |
| rSBA-MenW-135, M13, ≥ 1:128 | 65 | 7 |
| rSBA-MenW-135, M14, ≥ 1:128 | 138 | 131 |
| rSBA-MenY, M5, ≥ 1:128 | 159 | 16 |
| rSBA-MenY, M13, ≥ 1:128 | 70 | 23 |
| rSBA-MenY, M14, ≥ 1:128 | 137 | 131 |
Antibody titers are presented as geometric mean titers (GMTs).
| Titers | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|
| rSBA-MenA, M5, ≥ 1:8 | 1332.9 (1035.2 to 1716.2) | 4.8 (4.1 to 5.5) |
| rSBA-MenA, M13, ≥ 1:8 | 125.3 (84.4 to 186.1) | 7.2 (5.5 to 9.3) |
| rSBA-MenA, M14, ≥ 1:8 | 2762.3 (2310.3 to 3302.8) | 2918.7 (2264.6 to 3761.7) |
| rSBA-MenC, M5, ≥ 1:8 | 591.6 (482.3 to 725.8) | 4.7 (4.1 to 5.4) |
| rSBA-MenC, M13, ≥ 1:8 | 27.4 (20.6 to 36.6) | 4.2 (3.9 to 4.4) |
| rSBA-MenC, M14, ≥ 1:8 | 2525.2 (2102.1 to 3033.3) | 768.1 (593.0 to 995.0) |
| rSBA-MenW-135, M5, ≥ 1:8 | 1255.9 (917.0 to 1720.0) | 4.6 (4.0 to 5.2) |
| rSBA-MenW-135, M13, ≥ 1:8 | 63.3 (45.6 to 87.9) | 5.0 (4.2 to 5.8) |
| rSBA-MenW-135, M14, ≥ 1:8 | 3144.7 (2636.9 to 3750.4) | 5240.7 (3855.5 to 7123.7) |
| rSBA-MenY, M5, ≥ 1:8 | 1469.9 (1186.5 to 1821.0) | 6.3 (5.0 to 7.8) |
| rSBA-MenY, M13, ≥ 1:8 | 106.4 (76.4 to 148.1) | 9.4 (6.8 to 12.9) |
| rSBA-MenY, M14, ≥ 1:8 | 2748.6 (2301.4 to 3282.6) | 4202.5 (3219.9 to 5485.1) |
Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers \< 1:8 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers \>= 1:8 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination antibody titer.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| rSBA-MenA | 248 | 108 | 125 |
| rSBA-MenC | 270 | 129 | 126 |
| rSBA-MenW-135 | 272 | 122 | 128 |
| rSBA-MenY | 267 | 121 | 125 |
The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| hSBA-MenA, ≥ 1:4 | 136 | 58 | 9 |
| hSBA-MenC, ≥ 1:4 | 147 | 66 | 3 |
| hSBA-MenW-135, ≥ 1:4 | 107 | 41 | 0 |
| hSBA-MenY, ≥ 1:4 | 127 | 48 | 1 |
| hSBA-MenA, ≥ 1:8 | 136 | 58 | 8 |
| hSBA-MenC, ≥ 1:8 | 147 | 66 | 3 |
| hSBA-MenW-135, ≥ 1:8 | 107 | 41 | 0 |
| hSBA-MenY, ≥ 1:8 | 127 | 48 | 1 |
Antibody titers are presented as geometric mean titers (GMTs).
| Titers | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| hSBA-MenA | 808.0 (683.8 to 954.6) | 270.5 (205.9 to 355.4) | 2.6 (2.2 to 3.1) |
| hSBA-MenC | 3970.8 (3144.0 to 5015.1) | 523.1 (381.5 to 717.3) | 2.3 (1.9 to 2.9) |
| hSBA-MenW-135 | 1514.5 (1277.2 to 1795.8) | 136.5 (78.4 to 237.6) | 2.0 (2.0 to 2.0) |
| hSBA-MenY | 1276.2 (1077.3 to 1511.8) | 194.8 (117.6 to 322.9) | 2.1 (1.9 to 2.4) |
The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| hSBA-MenA, ≥ 1:4, M13 | 131 | 48 | 18 |
| hSBA-MenA, ≥ 1:4, M14 | 173 | 83 | 70 |
| hSBA-MenC, ≥ 1:4, M13 | 168 | 76 | 4 |
| hSBA-MenC, ≥ 1:4, M14 | 198 | 92 | 84 |
| hSBA-MenW-135, ≥ 1:4, M13 | 123 | 53 | 1 |
| hSBA-MenW-135, ≥ 1:4, M14 | 129 | 59 | 49 |
| hSBA-MenY, ≥ 1:4, M13 | 137 | 60 | 4 |
| hSBA-MenY, ≥ 1:4, M14 | 149 | 69 | 52 |
| hSBA-MenA, ≥ 1:8, M13 | 130 | 47 | 15 |
| hSBA-MenA, ≥ 1:8, M14 | 173 | 83 | 69 |
| hSBA-MenC, ≥ 1:8, M13 | 168 | 75 | 4 |
| hSBA-MenC, ≥ 1:8, M14 | 198 | 92 | 84 |
| hSBA-MenW-135, ≥ 1:8, M13 | 123 | 53 | 1 |
| hSBA-MenW-135, ≥ 1:8, M14 | 129 | 59 | 49 |
| hSBA-MenY, ≥ 1:8, M13 | 137 | 60 | 4 |
| hSBA-MenY, ≥ 1:8, M14 | 149 | 69 | 52 |
Antibody titers are presented as geometric mean titers (GMTs).
| Titers | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| hSBA-MenA, M13 | 64.6 (48.8 to 85.5) | 20.8 (13.5 to 32.2) | 3.2 (2.6 to 3.8) |
| hSBA-MenA, M14 | 2318.6 (1991.7 to 2699.1) | 1415.6 (1140.2 to 1757.5) | 196.3 (140.5 to 274.2) |
| hSBA-MenC, M13 | 209.0 (165.7 to 263.7) | 150.8 (108.5 to 209.5) | 2.3 (2.0 to 2.7) |
| hSBA-MenC, M14 | 15919.1 (13965.3 to 18146.2) | 13360.1 (10952.9 to 16296.4) | 363.3 (269.4 to 490.1) |
| hSBA-MenW-135, M13 | 307.9 (262.9 to 360.6) | 428.6 (328.4 to 559.2) | 2.1 (1.9 to 2.3) |
| hSBA-MenW-135, M14 | 8761.8 (7431.3 to 10330.5) | 9015.6 (7045.2 to 11537.1) | 221.7 (140.6 to 349.5) |
| hSBA-MenY, M13 | 363.2 (309.9 to 425.7) | 389.2 (292.3 to 518.1) | 2.6 (2.0 to 3.5) |
| hSBA-MenY, M14 | 5989.3 (5281.0 to 6792.6) | 5977.6 (4746.8 to 7527.6) | 281.5 (171.9 to 460.9) |
Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers \< 1:4 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers \>= 1:4 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| hSBA-MenA, Total | 130 | 61 | 51 |
| hSBA-MenC, Total | 163 | 73 | 65 |
| hSBA-MenW-135, Total | 106 | 40 | 37 |
| hSBA-MenY, Total | 115 | 45 | 30 |
The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-1, M5 | 82 | 42 | 37 |
| anti-1, M13 | 36 | 19 | 19 |
| anti-1, M14 | 61 | 29 | 29 |
| anti-4, M5 | 82 | 42 | 37 |
| anti-4, M13 | 38 | 22 | 20 |
| anti-4, M14 | 61 | 30 | 29 |
| anti-5, M5 | 81 | 42 | 37 |
| anti-5, M13 | 32 | 18 | 17 |
| anti-5, M14 | 60 | 29 | 27 |
| anti-6A, M5 | 51 | 31 | 22 |
| anti-6A, M13 | 44 | 26 | 16 |
| anti-6A, M14 | 51 | 25 | 24 |
| anti-6B, M5 | 81 | 41 | 37 |
| anti-6B, M13 | 55 | 31 | 22 |
| anti-6B, M14 | 61 | 30 | 28 |
| anti-7F, M5 | 82 | 42 | 37 |
| anti-7F, M13 | 55 | 32 | 23 |
| anti-7F, M14 | 61 | 29 | 29 |
| anti-9V, M5 | 82 | 42 | 37 |
| anti-9V, M13 | 47 | 24 | 17 |
| anti-9V, M14 | 61 | 29 | 29 |
| anti-14, M5 | 82 | 42 | 36 |
| anti-14, M13 | 56 | 33 | 25 |
| anti-14, M14 | 61 | 30 | 29 |
| anti-18C, M5 | 81 | 42 | 37 |
| anti-18C, M13 | 43 | 20 | 19 |
| anti-18C, M14 | 61 | 29 | 29 |
| anti-19A, M5 | 49 | 26 | 27 |
| anti-19A, M13 | 41 | 23 | 20 |
| anti-19A, M14 | 57 | 27 | 27 |
| anti-19F, M5 | 81 | 42 | 36 |
| anti-19F, M13 | 57 | 33 | 25 |
| anti-19F, M14 | 61 | 30 | 29 |
| anti-23F, M5 | 66 | 42 | 35 |
| anti-23F, M13 | 42 | 25 | 18 |
| anti-23F, M14 | 45 | 23 | 21 |
The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-1, M5 | 76 | 41 | 34 |
| anti-1, M13 | 12 | 5 | 8 |
| anti-1, M14 | 61 | 29 | 28 |
| anti-4, M5 | 81 | 41 | 37 |
| anti-4, M13 | 17 | 5 | 10 |
| anti-4, M14 | 58 | 29 | 29 |
| anti-5, M5 | 72 | 32 | 28 |
| anti-5, M13 | 10 | 5 | 5 |
| anti-5, M14 | 49 | 23 | 26 |
| anti-6A, M5 | 36 | 20 | 13 |
| anti-6A, M13 | 26 | 10 | 11 |
| anti-6A, M14 | 47 | 22 | 23 |
| anti-6B, M5 | 73 | 40 | 35 |
| anti-6B, M13 | 37 | 23 | 15 |
| anti-6B, M14 | 61 | 28 | 28 |
| anti-7F, M5 | 81 | 42 | 37 |
| anti-7F, M13 | 38 | 17 | 14 |
| anti-7F, M14 | 61 | 29 | 28 |
| anti-9V, M5 | 79 | 40 | 36 |
| anti-9V, M13 | 19 | 10 | 9 |
| anti-9V, M14 | 59 | 28 | 28 |
| anti-14, M5 | 80 | 41 | 36 |
| anti-14, M13 | 44 | 28 | 21 |
| anti-14, M14 | 61 | 29 | 28 |
| anti-18C, M5 | 79 | 41 | 36 |
| anti-18C, M13 | 18 | 9 | 11 |
| anti-18C, M14 | 61 | 27 | 29 |
| anti-19A, M5 | 28 | 14 | 13 |
| anti-19A, M13 | 25 | 15 | 5 |
| anti-19A, M14 | 52 | 21 | 22 |
| anti-19F, M5 | 80 | 42 | 36 |
| anti-19F, M13 | 52 | 30 | 20 |
| anti-19F, M14 | 61 | 30 | 29 |
| anti-23F, M5 | 62 | 42 | 32 |
| anti-23F, M13 | 28 | 14 | 12 |
| anti-23F, M14 | 45 | 23 | 20 |
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL)
| μg/mL | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-1, M5 | 1.3 (1.1 to 1.6) | 1.4 (1.1 to 1.8) | 1.5 (1.1 to 2.1) |
| anti-1, M13 | 0.2 (0.1 to 0.2) | 0.2 (0.1 to 0.2) | 0.2 (0.2 to 0.3) |
| anti-1, M14 | 2.1 (1.6 to 2.6) | 1.7 (1.2 to 2.5) | 2.2 (1.5 to 3.2) |
| anti-4, M5 | 1.7 (1.5 to 2.0) | 1.8 (1.4 to 2.2) | 1.8 (1.3 to 2.5) |
| anti-4, M13 | 0.2 (0.2 to 0.3) | 0.2 (0.2 to 0.3) | 0.3 (0.2 to 0.4) |
| anti-4, M14 | 2.4 (1.8 to 3.1) | 2.4 (1.8 to 3.1) | 3.1 (2.3 to 4.2) |
| anti-5, M5 | 0.6 (0.6 to 0.7) | 0.6 (0.5 to 0.7) | 0.7 (0.5 to 0.9) |
| anti-5, M13 | 0.2 (0.1 to 0.2) | 0.2 (0.1 to 0.2) | 0.2 (0.1 to 0.2) |
| anti-5, M14 | 0.7 (0.6 to 0.9) | 0.5 (0.4 to 0.7) | 0.7 (0.5 to 1.0) |
| anti-6A, M5 | 0.3 (0.3 to 0.4) | 0.4 (0.3 to 0.6) | 0.3 (0.2 to 0.4) |
| anti-6A, M13 | 0.3 (0.2 to 0.4) | 0.3 (0.2 to 0.4) | 0.2 (0.2 to 0.4) |
| anti-6A, M14 | 1.7 (1.3 to 2.3) | 1.4 (0.9 to 2.1) | 1.6 (1.0 to 2.5) |
| anti-6B, M5 | 1.8 (1.4 to 2.3) | 1.7 (1.3 to 2.4) | 1.8 (1.3 to 2.5) |
| anti-6B, M13 | 0.6 (0.4 to 0.7) | 0.5 (0.4 to 0.7) | 0.4 (0.3 to 0.7) |
| anti-6B, M14 | 3.8 (3.1 to 4.8) | 2.4 (1.7 to 3.5) | 3.4 (2.2 to 5.2) |
| anti-7F, M5 | 2.5 (2.2 to 3.0) | 2.2 (1.8 to 2.7) | 2.8 (2.1 to 3.7) |
| anti-7F, M13 | 0.4 (0.4 to 0.5) | 0.4 (0.3 to 0.5) | 0.4 (0.3 to 0.6) |
| anti-7F, M14 | 3.5 (2.9 to 4.2) | 2.2 (1.6 to 3.1) | 3.4 (2.4 to 4.9) |
| anti-9V, M5 | 1.2 (1.0 to 1.4) | 1.2 (1.0 to 1.5) | 1.3 (1.0 to 1.7) |
| anti-9V, M13 | 0.3 (0.2 to 0.4) | 0.3 (0.2 to 0.4) | 0.2 (0.1 to 0.3) |
| anti-9V, M14 | 1.6 (1.3 to 2.0) | 1.0 (0.8 to 1.4) | 1.6 (1.2 to 2.2) |
| anti-14, M5 | 5.2 (4.1 to 6.5) | 6.0 (4.4 to 8.0) | 7.0 (4.9 to 10.0) |
| anti-14, M13 | 1.0 (0.7 to 1.3) | 0.8 (0.6 to 1.0) | 0.9 (0.5 to 1.4) |
| anti-14, M14 | 8.4 (6.8 to 10.4) | 6.8 (4.8 to 9.7) | 9.0 (6.0 to 13.5) |
| anti-18C, M5 | 2.3 (1.9 to 2.8) | 2.0 (1.5 to 2.5) | 2.9 (2.2 to 3.8) |
| anti-18C, M13 | 0.2 (0.2 to 0.3) | 0.2 (0.1 to 0.3) | 0.3 (0.2 to 0.4) |
| anti-18C, M14 | 3.6 (3.0 to 4.4) | 2.3 (1.5 to 3.6) | 3.4 (2.6 to 4.6) |
| anti-19A, M5 | 0.2 (0.2 to 0.3) | 0.2 (0.2 to 0.4) | 0.2 (0.2 to 0.3) |
| anti-19A, M13 | 0.3 (0.2 to 0.4) | 0.3 (0.2 to 0.4) | 0.2 (0.1 to 0.3) |
| anti-19A, M14 | 1.2 (0.8 to 1.7) | 1.1 (0.6 to 1.9) | 0.8 (0.5 to 1.2) |
| anti-19F, M5 | 3.7 (3.0 to 4.6) | 3.8 (2.7 to 5.3) | 4.7 (3.3 to 6.6) |
| anti-19F, M13 | 0.9 (0.7 to 1.2) | 0.9 (0.7 to 1.3) | 0.9 (0.5 to 1.5) |
| anti-19F, M14 | 8.0 (6.2 to 10.2) | 6.9 (4.5 to 10.6) | 9.8 (6.8 to 14.2) |
| anti-23F, M5 | 1.4 (1.0 to 1.9) | 1.8 (1.4 to 2.4) | 1.5 (1.0 to 2.2) |
| anti-23F, M13 | 0.3 (0.2 to 0.4) | 0.3 (0.2 to 0.4) | 0.2 (0.2 to 0.4) |
| anti-23F, M14 | 3.4 (2.6 to 4.5) | 2.1 (1.3 to 3.4) | 2.9 (1.8 to 4.7) |
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-D) Antibodies | 72 | 34 | 38 |
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
| IU/mL | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Concentration of Antibodies Against Diphtheria Antigens (Anti-D) | 2.259 (1.820 to 2.804) | 3.028 (2.177 to 4.213) | 2.462 (1.700 to 3.565) |
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
| IU/mL | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Concentration of Antibodies Against Diphtheria Antigens (Anti-D) | 2.435 (1.958 to 3.028) | 3.069 (2.225 to 4.233) | 2.423 (1.688 to 3.479) |
Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
| EL.U/mL | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-PT, M5 | 49.9 (43.3 to 57.6) | 51.9 (40.8 to 66.0) | 47.8 (38.3 to 59.7) |
| anti-FHA, M5 | 126.2 (108.8 to 146.3) | 134.2 (108.3 to 166.4) | 132.6 (107.8 to 163.1) |
| anti-PRN, M5 | 108.6 (88.8 to 132.9) | 167.5 (117.6 to 238.7) | 158.2 (106.5 to 235.1) |
Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-PT, M5 | 77 | 36 | 40 |
| anti-FHA, M5 | 77 | 36 | 40 |
| anti-PRN, M5 | 77 | 36 | 39 |
Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
| EL.U/mL | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-PT, M5 | 50.4 (43.9 to 57.8) | 54.7 (42.9 to 69.9) | 46.4 (37.0 to 58.1) |
| anti-FHA, M5 | 127.3 (110.6 to 146.6) | 143.3 (114.4 to 179.4) | 129.4 (105.1 to 159.2) |
| anti-PRN, M5 | 116.7 (95.2 to 143.1) | 178.9 (125.5 to 255.1) | 154.8 (105.0 to 228.3) |
Antibody titers are presented as geometric mean titers (GMTs).
| Titers | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-Polio 1, M5 | 788.8 (584.1 to 1065.2) | 1102.9 (725.2 to 1677.2) | 908.6 (549.1 to 1503.4) |
| anti-Polio 2, M5 | 850.4 (647.3 to 1117.3) | 953.3 (579.0 to 1569.5) | 1079.2 (704.9 to 1652.1) |
| anti-Polio 3, M5 | 1678.8 (1211.2 to 2326.9) | 1676.7 (1011.1 to 2780.5) | 1261.3 (720.8 to 2207.1) |
Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
| Titers | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-Polio 1, M5 | 827.2 (618.7 to 1105.8) | 1048.1 (681.1 to 1612.7) | 861.0 (523.3 to 1416.8) |
| anti-Polio 2, M5 | 931.3 (707.7 to 1225.6) | 990.4 (606.5 to 1617.3) | 1024.0 (668.6 to 1568.2) |
| anti-Polio 3, M5 | 1709.5 (1245.4 to 2346.7) | 1618.7 (963.7 to 2719.0) | 1184.8 (679.9 to 2064.4) |
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-T, M5 | 77 | 36 | 40 |
| anti-T, M13 | 58 | 28 | 24 |
| anti-T, M14 | 62 | 22 | 23 |
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
| IU/mL | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-T, M5 | 5.798 (4.998 to 6.726) | 7.246 (5.305 to 9.897) | 5.973 (4.818 to 7.406) |
| anti-T, M13 | 0.479 (0.398 to 0.576) | 0.659 (0.427 to 1.018) | 0.461 (0.297 to 0.716) |
| anti-T, M14 | 18.977 (16.013 to 22.489) | 16.813 (12.386 to 22.821) | 35.835 (23.802 to 53.951) |
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| anti-T, M5 | 77 | 36 | 40 |
| anti-T, M13 | 58 | 28 | 24 |
| anti-T, 14 | 62 | 22 | 23 |
The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate \[anti-PRP\] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.
No measurements were reported for this outcome.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Any Pain Dose 1 | 220 | 115 | 108 |
| Grade 3 Pain Dose 1 | 38 | 25 | 14 |
| Any Redness Dose 1 | 94 | 39 | 43 |
| Grade 3 Redness Dose 1 | 1 | 0 | 0 |
| Any Swelling Dose 1 | 84 | 31 | 34 |
| Grade 3 Swelling Dose 1 | 0 | 3 | 0 |
| Any Pain Dose 2 | 177 | 92 | 101 |
| Grade 3 Pain Dose 2 | 33 | 11 | 16 |
| Any Redness Dose 2 | 93 | 51 | 48 |
| Grade 3 Redness Dose 2 | 2 | 0 | 1 |
| Any Swelling Dose 2 | 76 | 47 | 42 |
| Grade 3 Swelling Dose 2 | 2 | 2 | 0 |
| Any Pain Dose 3 | 148 | 73 | 93 |
| Grade 3 Pain Dose 3 | 16 | 18 | 9 |
| Any Redness Dose 3 | 74 | 46 | 42 |
| Grade 3 Redness Dose 3 | 1 | 1 | 1 |
| Any Swelling Dose 3 | 66 | 46 | 37 |
| Grade 3 Swelling Dose 3 | 1 | 0 | 0 |
| Any Pain Across Doses | 262 | 135 | 142 |
| Grade 3 Pain Across Doses | 65 | 36 | 33 |
| Any Redness Across Doses | 160 | 79 | 78 |
| Grade 3 Redness Across Doses | 4 | 1 | 2 |
| Any Swelling Across Doses | 147 | 74 | 70 |
| Grade 3 Swelling Across Doses | 3 | 4 | 0 |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Any Pain | 139 | 71 | 77 |
| Grade 3 Pain | 21 | 19 | 14 |
| Any Redness | 74 | 32 | 39 |
| Grade 3 Redness | 1 | 1 | 3 |
| Any Swelling | 55 | 29 | 33 |
| Grade 3 Swelling | 2 | 1 | 3 |
Assessed solicited general symptoms were temperature \[defined as rectally temperature equal to or above 38 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Any Drowsiness Dose 1 | 177 | 93 | 84 |
| Grade 3 Drowsiness Dose 1 | 18 | 10 | 2 |
| Related Drowsiness Dose 1 | 160 | 84 | 79 |
| Any Irritability Dose 1 | 200 | 107 | 99 |
| Grade 3 Irritability Dose 1 | 19 | 9 | 10 |
| Related Irritability Dose 1 | 188 | 96 | 89 |
| Any Loss of appetite Dose 1 | 109 | 62 | 42 |
| Grade 3 Loss of appetite Dose 1 | 7 | 5 | 3 |
| Related Loss of appetite Dose 1 | 99 | 55 | 35 |
| Any Temperature Dose 1 | 126 | 62 | 58 |
| Grade 3 Temperature Dose 1 | 0 | 0 | 1 |
| Related Temperature Dose 1 | 109 | 56 | 53 |
| Any Drowsiness Dose 2 | 116 | 72 | 67 |
| Grade 3 Drowsiness Dose 2 | 9 | 8 | 8 |
| Related Drowsiness Dose 2 | 109 | 69 | 62 |
| Any Irritability Dose 2 | 163 | 82 | 90 |
| Grade 3 Irritability Dose 2 | 20 | 14 | 10 |
| Related Irritability Dose 2 | 158 | 77 | 85 |
| Any Loss of appetite Dose 2 | 89 | 50 | 44 |
| Grade 3 Loss of appetite Dose 2 | 6 | 5 | 6 |
| Related Loss of appetite Dose 2 | 80 | 48 | 39 |
| Any Temperature Dose 2 | 119 | 64 | 63 |
| Grade 3 Temperature Dose 2 | 0 | 0 | 0 |
| Related Temperature Dose 2 | 116 | 59 | 54 |
| Any Drowsiness Dose 3 | 102 | 54 | 64 |
| Grade 3 Drowsiness Dose 3 | 11 | 8 | 4 |
| Related Drowsiness Dose 3 | 95 | 54 | 60 |
| Any Irritability Dose 3 | 140 | 73 | 73 |
| Grade 3 Irritability Dose 3 | 14 | 14 | 3 |
| Related Irritability Dose 3 | 132 | 72 | 69 |
| Any Loss of appetite Dose 3 | 76 | 43 | 50 |
| Grade 3 Loss of appetite Dose 3 | 7 | 6 | 3 |
| Related Loss of appetite Dose 3 | 63 | 41 | 46 |
| Any Temperature Dose 3 | 109 | 51 | 41 |
| Grade 3 Temperature Dose 3 | 2 | 0 | 0 |
| Related Temperature Dose 3 | 96 | 46 | 36 |
| Any Drowsiness Across Doses | 217 | 121 | 118 |
| Grade 3 Drowsiness Across Doses | 30 | 19 | 13 |
| Related Drowsiness Across Doses | 205 | 116 | 114 |
| Any Irritability Across Doses | 254 | 128 | 126 |
| Grade 3 Irritability Across Doses | 42 | 27 | 18 |
| Related Irritability Across Doses | 246 | 125 | 121 |
| Any Loss of appetite Across | 165 | 89 | 82 |
| Grade 3 Loss of appetite Across | 17 | 13 | 10 |
| Related Loss of appetite Across | 151 | 84 | 77 |
| Any Temperature Across Doses | 203 | 102 | 101 |
| Grade 3 Temperature Across Doses | 2 | 0 | 1 |
| Related Temperature Across Doses | 193 | 97 | 93 |
Assessed solicited general symptoms were temperature \[defined as rectally temperature equal to or above 38 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Any Drowsiness | 79 | 46 | 43 |
| Grade 3 Drowsiness | 4 | 7 | 5 |
| Related Drowsiness | 75 | 42 | 43 |
| Any Irritability | 112 | 54 | 61 |
| Grade 3 Irritability | 9 | 12 | 10 |
| Related Irritability | 106 | 52 | 60 |
| Any Loss of appetite | 69 | 37 | 39 |
| Grade 3 Loss of appetite | 5 | 5 | 1 |
| Related Loss of appetite | 60 | 34 | 37 |
| Any Temperature | 68 | 35 | 27 |
| Grade 3 Temperature | 2 | 1 | 0 |
| Related Temperature | 62 | 32 | 24 |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Any AE(s) Dose 1 | 67 | 36 | 34 |
| Any AE(s) Dose 2 | 70 | 34 | 28 |
| Any AE(s) Dose 3 | 97 | 49 | 45 |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase) | 58 | 32 | 36 |
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 16 | 8 | 4 |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 35 | 14 | 14 |
Collected over Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nimenrix 3+1 Group | 0/376 (0%) | 35/376 (9.3%) | 334/376 (88.8%) |
| Nimenrix 1+1 Group | 0/187 (0%) | 14/187 (7.5%) | 169/187 (90.4%) |
| Nimenrix Control Group | 1/187 (0.5%) | 14/187 (7.5%) | 169/187 (90.4%) |
| Event | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| PneumoniaInfections and infestations | 13/376 | 2/187 | 3/187 |
| BronchiolitisInfections and infestations | 5/376 | 1/187 | 3/187 |
| GastroenteritisInfections and infestations | 4/376 | 1/187 | 3/187 |
| Escherichia urinary tract infectionInfections and infestations | 1/376 | 2/187 | 0/187 |
| NasopharyngitisInfections and infestations | 0/376 | 0/187 | 2/187 |
| Urinary tract infectionInfections and infestations | 2/376 | 2/187 | 0/187 |
| Head injuryInjury, poisoning and procedural complications | 0/376 | 2/187 | 0/187 |
| BronchitisInfections and infestations | 3/376 | 0/187 | 1/187 |
| DiarrhoeaGastrointestinal disorders | 2/376 | 0/187 | 1/187 |
| Sudden infant death syndromeGeneral disorders | 0/376 | 0/187 | 1/187 |
| Event | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group |
|---|---|---|---|
| PainGeneral disorders | 273/376 | 142/187 | 145/187 |
| IrritabilityPsychiatric disorders | 262/376 | 130/187 | 130/187 |
| SomnolenceNervous system disorders | 224/376 | 124/187 | 120/187 |
| PyrexiaGeneral disorders | 215/376 | 112/187 | 111/187 |
| Decreased appetiteMetabolism and nutrition disorders | 185/376 | 95/187 | 95/187 |
| ErythemaSkin and subcutaneous tissue disorders | 177/376 | 87/187 | 87/187 |
| SwellingGeneral disorders | 157/376 | 83/187 | 78/187 |
| NasopharyngitisInfections and infestations | 65/376 | 27/187 | 26/187 |
| PharyngitisInfections and infestations | 39/376 | 17/187 | 27/187 |
| DiarrhoeaGastrointestinal disorders | 36/376 | 15/187 | 10/187 |
| Age, Continuous(Weeks) | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group | Total |
|---|---|---|---|---|
| Mean | 8.1 ± 1.6 | 8.1 ± 1.7 | 8.2 ± 1.7 | 8.12 ± 1.65 |
| Sex: Female, Male(Participants) | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group | Total |
|---|---|---|---|---|
| Female | 182 | 105 | 95 | 382 |
| Male | 194 | 82 | 92 | 368 |
| Race/Ethnicity, Customized(Participants) | Nimenrix 3+1 Group | Nimenrix 1+1 Group | Nimenrix Control Group | Total |
|---|---|---|---|---|
| White - Arabic / North African Heritage | 199 | 100 | 99 | 398 |
| White - Caucasian / European Heritage | 1 | 0 | 1 | 2 |
| Mixed Origin | 176 | 87 | 87 | 350 |
Ran from Jan 2012 to primary completion in Aug 2014, 30 months.
Results were first posted in Aug 2019, 5 years after primary completion. A results delay was requested in Mar 2015.
Of 46 industry-sponsored phase 3 interventional studies under Meningococcal Infections, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's 30 months is above that.
Counting every sponsor, half of 46 studies reached it within 15 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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