TerminatedPhase 2

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

Stopped: The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.

Germany, Greece, Spain326 participantsStarted 2020-11-26

Plain-language 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.

Who can participate

Age range2 Months – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT04645966

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-15

Results submitted2023-09-11

View on ClinicalTrials.gov More Meningococcal Vaccine trials

Who can participate

Age range2 Months – 6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Timeframe: 1 month after primary vaccination 2

Timeframe: 1 month after booster vaccination

Timeframe: 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

Timeframe: 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

Timeframe: 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