Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nimenrix Nimenrix |
Biological: Nimenrix
MenACWY-TT vaccine
|
Outcome Measures
Primary Outcome Measures
- The percentage of participants reporting local reactions within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [7 days]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- The percentage of participants reporting systemic events within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [7 days]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- The percentage of participants reporting the use of antipyretic medication within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [7 days]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- The percentage of participants reporting at least 1 adverse event within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [30 days]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- The percentage of participants reporting at least 1 immediate adverse event after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [30 minutes]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- The percentage of participants reporting at least 1 serious adverse event within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [30 days]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- The percentage of participants reporting at least 1 newly diagnosed chronic medical condition within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [30 days]
Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.
- Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [Month 9]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age ) of Nimenrix. [Month 10]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age) of Nimenrix [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix [Month 9]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix [Month 10]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
Secondary Outcome Measures
- The percentage of participants reporting local reactions within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [7 days]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting systemic events within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [7 days]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting the use of antipyretic medication within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [7 days]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 adverse event within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [30 days]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 immediate adverse event within 30 minutes after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [30 minutes]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 serious adverse event within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [30 days]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 serious adverse event from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [8 months]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 serious adverse event from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [9 months]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 newly diagnosed chronic medical condition within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [30 days]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 newly diagnosed chronic medical condition event from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [8 months]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- The percentage of participants reporting at least 1 newly diagnosed chronic medical condition from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [9 months]
Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age
- Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age
- Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:4 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:4 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [Month 9]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [Month 10]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [Baseline]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [Month 1]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [Month 9]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [Month 10]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [Month 9]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [Month 10]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [Month 9]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
- Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [Month 10]
Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
-
Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
-
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
-
Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
-
Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.
Exclusion Criteria:
-
Previous anaphylactic reaction to any vaccine or vaccine-related component.
-
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
-
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
-
Significant neurological disorder or history of seizure (including simple febrile seizure).
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
-
Family history of congenital or hereditary immunodeficiency.
-
Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
-
Major known congenital malformation or serious chronic disorder.
-
Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampere Vaccine Research Clinic | Tampere | Pirkanmaa | Finland | 33100 |
| 2 | Espoo Vaccine Research Clinic | Espoo | Finland | 02230 | |
| 3 | Helsinki South Vaccine Research Clinic | Helsinki | Finland | 00100 | |
| 4 | Helsinki East Vaccine Research Clinic | Helsinki | Finland | 00930 | |
| 5 | Jarvenpaa Vaccine Research Center | Jarvenpaa | Finland | 04400 | |
| 6 | Turku Vaccine Research Clinic | Turku | Finland | 20520 | |
| 7 | IN VIVO Bydgoszcz | Bydgoszcz | Poland | 85-048 | |
| 8 | NZOZ Vitamed | Bydgoszcz | Poland | 85-079 | |
| 9 | Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o. | Krakow | Poland | 30-348 | |
| 10 | GRAVITA. Diagnostyka i Leczenie nieplodnosci | Lodz | Poland | 91-347 | |
| 11 | Szpital im. Św. Jadwigi Śląskiej w Trzebnicy | Trzebnica | Poland | 55-100 | |
| 12 | CHUS - Hospital Clinico Universitario | Santiago de Compostela | A Coruna | Spain | 15706 |
| 13 | Hospital Universitario HM Sanchinarro | Madrid | Spain | 28050 | |
| 14 | Instituto Hispalense de Pediatria | Sevilla | Spain | 41012 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C0921062
- 2020-005059-19