Overview

This trial is active, not recruiting.

Condition meningococcal disease
Treatments rmenb+omv and menacwy, rmenb+omv, menacwy
Phase phase 3
Sponsor Novartis
Collaborator Novartis Vaccines
Start date June 2014
End date October 2016
Trial size 750 participants
Trial identifier NCT02106390, V72_56

Summary

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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
co-administration
rmenb+omv and menacwy
rMenB+OMV given concomitantly with MenACWY at 3,5,7 and 13 months of age
(Active Comparator)
MenB
rmenb+omv
rMenB+OMV given at 3,5,7 and 13 months of age
(Active Comparator)
MenACWY
menacwy
MenACWY given at 3,5,7 and 13 months of age

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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Percentage of subjects with solicited AE, unsolicited AE, medically attended AEs, AEs leading to withdrawn and SAEs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

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Novartis.