A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

NCT04645966 | Terminated Phase 2 Results DMC

• 2 other identifiers: C35110022020-000948-60
• Study Type: interventional
• Target: 326
• Locations: 3 countries
• Sites: 21

Brief Summary

The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Conditions

Meningococcal Vaccine

Keywords

Meningococcal Vaccine; Invasive Meningococcal Disease; Meningococcal Serogroups A, B, C W and Y; MenABCWY Vaccine

Outcome Measures

Primary Outcomes (24)

• Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Percentage of participants achieving hSBA titer greater than or equal to (\>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.

  1 month after primary vaccination 2

• Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Percentage of participants achieving hSBA titer \>= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.

  1 month after booster vaccination

• Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.

  1 month After primary vaccination 2

• Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5

  Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.

  1 month after primary vaccination 2

• Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Percentage of participants achieving hSBA titer\>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.

  1 Month after booster vaccination

• Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5

  Percentage of participants achieving hSBA titer \>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.

  1 Month after booster vaccination

• Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.

  Within 7 days after primary vaccination 1

• Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined

  Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.

  Within 7 Days after primary Vaccination 2

• Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius(C) and was 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 was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method

  Within 7 Days after primary Vaccination 1

• Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined

  Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg C and was 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 was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.

  Within 7 days after primary vaccination 2

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  An adverse event (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. A serious adverse event (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. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after primary vaccination 1

• Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after primary vaccination 2

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after any primary vaccination

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2

• Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after primary vaccination 2 up to booster vaccination

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.

  From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)

• Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined

  Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.

  Within 30 minutes After primary vaccination 1

• Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined

  Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.

  Within 30 minutes After primary vaccination 2

• Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.

  Within 30 minutes after booster vaccination

• Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.

  Within 7 Days after booster vaccination

• Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature \>=38.0 deg 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 was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.

  Within 7 days after booster vaccination

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From date of booster vaccination through 1 month after booster vaccination

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined

  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. 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. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)

Secondary Outcomes (5)

• hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5

  1 Month after primary Vaccination 2

• hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5

  1 month after booster vaccination

• Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5

  Within 7 Days after primary Vaccination(Vac) 1 and 2

• Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5

  Within 7 Days after primary Vaccination 1 and 2

• Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5

  Within 30 days after any vaccination

Study Arms (11)

MenABCWY with PLP - 6 months of age

EXPERIMENTAL

Group 1 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations.

Biological: MenABCWY; Drug: Prophylactic Liquid Paracetamol (PLP)

MenABCWY - 6 months of age

EXPERIMENTAL

Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule

Biological: MenABCWY

Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age

EXPERIMENTAL

Group 3 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP or Scheduled Liquid Pracetamol (SLP) during primary vaccinations.

Biological: Bivalent rLP2086 (60-µg Dose); Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix; Drug: Scheduled Liquid Paracetamol (SLP)

Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age

EXPERIMENTAL

Group 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule

Biological: Bivalent rLP2086 (60-µg Dose); Biological: Nimenrix

Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age

EXPERIMENTAL

Group 5 - Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations.

Biological: Bivalent rLP2086 (120-µg Dose); Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix

MenABCWY with SLP - 2 months of age

EXPERIMENTAL

Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations.

Biological: MenABCWY; Drug: Scheduled Liquid Paracetamol (SLP)

Bexsero and Nimenrix with PLP - 2 months of age

EXPERIMENTAL

Group 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations

Biological: Bexsero; Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix

Bexsero and Nimenrix - 2 months of age

EXPERIMENTAL

Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule

Biological: Bexsero; Biological: Nimenrix

MenABCWY with TLP - 2 months of age

EXPERIMENTAL

Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations.

Biological: MenABCWY; Drug: Therapeutic Liquid Paracetamol (TLP)

Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age

EXPERIMENTAL

Group 13 - Participants 2 months of age vaccinated with MenABCWY and placebo on a 2+1 schedule, with a determined ratio of participants given SLP or TLP during primary vaccinations.

Biological: MenABCWY; Other: Placebo; Drug: Scheduled Liquid Paracetamol (SLP); Drug: Therapeutic Liquid Paracetamol (TLP)

Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age

EXPERIMENTAL

Group 14 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule with a determined ratio of participants given PLP or TLP during primary vaccinations.

Biological: Bexsero; Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix; Drug: Therapeutic Liquid Paracetamol (TLP)

Interventions

MenABCWY BIOLOGICAL

Neisseria meningitis groups A, B, C W, and Y vaccine

Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age; MenABCWY - 6 months of age; MenABCWY with PLP - 6 months of age; MenABCWY with SLP - 2 months of age; MenABCWY with TLP - 2 months of age

Bivalent rLP2086 (60-µg Dose) BIOLOGICAL

Trumenba (half dose) - Meningococcal Group B vaccine

Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age; Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age

Bivalent rLP2086 (120-µg Dose) BIOLOGICAL

Trumenba - Meningococcal Group B vaccine

Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age

Bexsero BIOLOGICAL

Bexsero - Meningococcal Group B vaccine

Bexsero and Nimenrix - 2 months of age; Bexsero and Nimenrix with PLP - 2 months of age; Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age

Prophylactic Liquid Paracetamol (PLP) DRUG

PLP administration during primary vaccinations 1 and 2

Bexsero and Nimenrix with PLP - 2 months of age; Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age; Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age; Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age; MenABCWY with PLP - 6 months of age

Nimenrix BIOLOGICAL

Nimenrix - Meningococcal Group A, C, W and Y vaccine

Bexsero and Nimenrix - 2 months of age; Bexsero and Nimenrix with PLP - 2 months of age; Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age; Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age; Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age; Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age

Placebo OTHER

Normal Saline

Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age

Scheduled Liquid Paracetamol (SLP) DRUG

SLP administration after primary vaccinations 1 and 2.

Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age; Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age; MenABCWY with SLP - 2 months of age

Therapeutic Liquid Paracetamol (TLP) DRUG

TLP administration after primary vaccinations 1 and 2

Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age; Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age; MenABCWY with TLP - 2 months of age

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization.
• Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone.
• Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
• Body weight ≥4 kg for participants 2 months of age at the time of randomization.
• Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

You may not qualify if:

• Prior adverse reaction to paracetamol use, including allergic reactions.
• Participant was born prematurely (\<37 weeks of gestation).
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the SRM for additional details.
• History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Significant neurological disorder or history of seizure (including simple febrile seizure).
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
• For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine.
• Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• Receipt of any blood products, including immunoglobulin, before the first study vaccination.
• Current chronic use of systemic antibiotics.
• Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (21)

Dr. med Falko Panzer Praxis fuer Kinder und Jugendliche

Mannheim, 68161, Germany

Location

P. & A. Kyriakou Children's Hospital

Athens, 11527, Greece

Location

University General Hospital "ATTIKON"

Athens, 12462, Greece

Location

"Ippokratio" General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario de Burgos

Burgos, Castille and León, 09006, Spain

Location

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Centro de Salud L'Eliana

L'Eliana, Valencia, 46183, Spain

Location

Centro de Salud de Paiporta

Paiporta, Valencia, 46200, Spain

Location

Hospital Vithas Virgen del Mar

Almería, 04120, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Grupo Pediatrico Uncibay

Málaga, 29015, Spain

Location

Instituto Hispalense de Pediatria

Seville, 41012, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

FISABIO

Valencia, 46020, Spain

Location

Centro de Salud la Serreria II

Valencia, 46022, Spain

Location

Centro de Salud Nazaret

Valencia, 46024, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

4CMenB vaccine

Limitations and Caveats

Study was terminated based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Open label for Groups 1-5,7,8,10 and 11, no masking; Groups 13-14 is blinded.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: November 26, 2020
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (17); DE (1); GR (3)