Adults 76 Days to 104 Days, any sex, with Meningococcal Vaccine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2Primary· Within 7 days after vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper a
Pain at injection site: Mild
Group
Value
95% CI
Nimenrix
19.7
13.5 – 27.2
Pain at injection site: Moderate
Group
Value
95% CI
Nimenrix
7.7
3.9 – 13.4
Pain at injection site: Severe
Group
Value
95% CI
Nimenrix
0
0.0 – 2.6
Redness: Mild
Group
Value
95% CI
Nimenrix
14.1
8.8 – 20.9
Redness: Moderate
Group
Value
95% CI
Nimenrix
2.8
0.8 – 7.1
Redness: Severe
Group
Value
95% CI
Nimenrix
0
0.0 – 2.6
Swelling: Mild
Group
Value
95% CI
Nimenrix
4.9
2.0 – 9.9
Swelling: Moderate
Group
Value
95% CI
Nimenrix
1.4
0.2 – 5.0
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2Primary· Within 7 days after vaccination 2
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees (deg) Celsius (C), categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with da
Fever: >=38.0 deg C to 38.4 deg C
Group
Value
95% CI
Nimenrix
6.3
2.9 – 11.7
Fever: >38.4 deg C to 38.9 deg C
Group
Value
95% CI
Nimenrix
4.9
2.0 – 9.9
Fever: >38.9 deg C to 40.0 deg C
Group
Value
95% CI
Nimenrix
3.5
1.2 – 8.0
Fever: >40.0 deg C
Group
Value
95% CI
Nimenrix
0
0.0 – 2.6
Decreased appetite: Mild
Group
Value
95% CI
Nimenrix
19.7
13.5 – 27.2
Decreased appetite: Moderate
Group
Value
95% CI
Nimenrix
11.3
6.6 – 17.7
Decreased appetite: Severe
Group
Value
95% CI
Nimenrix
1.4
0.2 – 5.0
Increased sleep: Mild
Group
Value
95% CI
Nimenrix
38.0
30.0 – 46.5
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2Primary· Within 7 days after vaccination 2
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Group
Value
95% CI
Nimenrix
55.6
47.1 – 64.0
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2Primary· Within 30 days after vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Group
Value
95% CI
Nimenrix
19.6
13.4 – 27.0
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2Primary· Within 30 days after vaccination 2
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Group
Value
95% CI
Nimenrix
1.4
0.2 – 5.0
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2Primary· Within 30 days after vaccination 2
An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Group
Value
95% CI
Nimenrix
0.0
0.0 – 2.5
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2Primary· Within 30 minutes after vaccination 2
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Group
Value
95% CI
Nimenrix
0.0
0.0 – 2.5
Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity PopulationPrimary· At baseline (before vaccination 1)
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP).
MenA
Group
Value
95% CI
Nimenrix
0.0
0.0 – 2.8
MenC
Group
Value
95% CI
Nimenrix
4.7
1.7 – 9.9
MenW-135
Group
Value
95% CI
Nimenrix
0.8
0.0 – 4.3
MenY
Group
Value
95% CI
Nimenrix
7.8
3.8 – 13.9
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity PopulationPrimary· 1 month after vaccination 1
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
MenA
Group
Value
95% CI
Nimenrix
82.3
74.4 – 88.5
MenC
Group
Value
95% CI
Nimenrix
91.1
84.7 – 95.5
MenW-135
Group
Value
95% CI
Nimenrix
89.5
82.7 – 94.3
MenY
Group
Value
95% CI
Nimenrix
90.3
83.7 – 94.9
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity PopulationPrimary· At vaccination 2
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
MenA
Group
Value
95% CI
Nimenrix
33.6
25.4 – 42.6
MenC
Group
Value
95% CI
Nimenrix
64.8
55.8 – 73.1
MenW-135
Group
Value
95% CI
Nimenrix
67.2
58.2 – 75.3
MenY
Group
Value
95% CI
Nimenrix
66.4
57.4 – 74.6
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity PopulationPrimary· 1 month after vaccination 2
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
MenA
Group
Value
95% CI
Nimenrix
100.0
97.2 – 100.0
MenC
Group
Value
95% CI
Nimenrix
100.0
97.2 – 100.0
MenW-135
Group
Value
95% CI
Nimenrix
100.0
97.2 – 100.0
MenY
Group
Value
95% CI
Nimenrix
100.0
97.2 – 100.0
Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity PopulationPrimary· At baseline (before vaccination 1)
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
MenA
Group
Value
95% CI
Nimenrix
4.0
4.0 – 4.0
MenC
Group
Value
95% CI
Nimenrix
4.4
4.0 – 4.7
MenW-135
Group
Value
95% CI
Nimenrix
4.1
3.9 – 4.3
MenY
Group
Value
95% CI
Nimenrix
5.0
4.3 – 5.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Local reactions and systemic events were recorded using systematic assessment within 7 days after Vaccination 1 and 2; SAEs and all-cause mortality recorded using non-systematic assessment from Day 1 up to 42 days after Vaccination 2 (approximately 10 months and 12 days); other AEs recorded using non-systematic assessment from Day 1 up to 42 days after Vaccination 1 and from Day of Vaccination 2 up to 42 days after Vaccination 2.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants \<6 months of age, followed by the booster at 12 months
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07286370 — A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal S
· Phase 2
· not yet recruiting
NCT05743881 — A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
· Phase 1
· active not recruiting
NCT04645966 — A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
· Phase 2
· terminated
NCT03606512 — A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial
· Phase 1, PHASE2
· completed
NCT00514904 — Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
· Phase 3
· completed
Other Pfizer trials
Trials by the same sponsor.
NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna®
· not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market
· not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea
· not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta
· Phase 1
· not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04819113.