Safety and Immunogenicity of Novartis Meningococcal Group B Vaccine When Administered Concomitantly With Novartis MenACWY Conjugate Vaccine to Healthy Infants
This trial is active, not recruiting.
|Treatments||rmenb+omv and menacwy, rmenb+omv, menacwy|
|Start date||June 2014|
|End date||October 2016|
|Trial size||750 participants|
|Trial identifier||NCT02106390, V72_56|
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Belgrano, Argentina||405, Novartis Investigational Site||no longer recruiting|
|Ciudad Autonoma de Buenos Aires, Argentina||Site 401 Novartis Investigational Site||no longer recruiting|
|Ciudad Autonoma de Buenos Aires, Argentina||Site 402, Novartis Investigational Site||no longer recruiting|
|Ciudad Autonoma de Buenos Aires, Argentina||Site 403, Novartis investigational Site||no longer recruiting|
|Mendoza, Argentina||Site 404, Novartis Investigational Site||no longer recruiting|
|Mexico City, Mexico||Novartis Investigational Site 100||no longer recruiting|
|Mexico City, Mexico||Site 112, Novartis Investigational Site||no longer recruiting|
|Mexico City, Mexico||Site 109, Novartis nvestigational Site||no longer recruiting|
|Mexico City, Mexico||Site 113, Novartis Investigational Site||no longer recruiting|
|Morelia Michoacan, Mexico||Novartis Investigational Site 102||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Between-group ratios of hSBA Geometric Mean Titers (GMTs) for all serogroups B (all indicator strains), A, C, W-135 and Y.
time frame: 30 days after 4th vaccination
hSBA GMT, percentage of subjects with hSBA ≥1:5 and percentage of subjects with hSBA ≥ 1:8 against serogroups B (all indicator strains), A, C, W-135 and Y
time frame: 30 days after 3th vaccination, pre-4th vaccination and 30 days after 4th vaccination
Within subject Geometric Mean Ratios (GMRs) and percentage of subject with four-fold increase in hSBA titers, at one months after fourth vaccination versus pre-fourth vaccination
time frame: 30 days after 4th vaccination
Percentage of subjects with solicited AE, unsolicited AE, medically attended AEs, AEs leading to withdrawn and SAEs
time frame: participants will be followed for the duration of study, within an expected average of 11 months
Male or female participants from 85 days up to 119 days old.
Inclusion Criteria: - Healthy 3-month old infants whose parents/legal guardians have given written informed consent - Available for all the visits scheduled in the study. - In good health as determined by medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria: - History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational) at the time of enrollment. - Previous known or suspected disease caused by N. meningitidis. - Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization. - Family members or household members of site research staff. - History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine. - Known or suspected autoimmune disease or impairment/alteration of the immune system - Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth. - History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable). - Receipt of any investigational or non-registered product (drug or vaccine) since birth (3 month prior) or are expected to receive during the study period. - History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
|Official title||A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of Novartis Meningococcal Group B Vaccine When Administered Concomitantly With Novartis MenACWY Conjugate Vaccine to Healthy Infants|
Call for more information