Clinical Trial: Safety and Immunogenicity of Novartis Meningococcal Group B Vaccine When Administered Concomitantly With Novartis MenACWY Conjugate Vaccine to Healthy Infants
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (for rMenB+OMV NZ) and serogroups A, C, W-135 and Y (for MenACWY) [ Time Frame: One month after the fourth vaccination ]
- Between-group ratios of GMTs for rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ (serogroup B indicator strains), and rMenB+OMV NZ +MenACWY versus MenACWY (serogroups A, C, W-135 and Y [ Time Frame: One month after the fourth vaccination ]Non-inferiority will be concluded if, at one month following the fourth vaccination, the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ, and rMenB+OMV NZ + MenACWY versus MenACWY) is > 0.5 for all serogroup B indicator strains and all serogroups A, C, W-135 and Y.
Original Primary Outcome: 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 ]
Current Secondary Outcome:
- Evaluation of immune response of rMenB+OMV NZ by hSBA GMTs against each of the serogroup B indicator strains [ Time Frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination ]
- Evaluation of immune response of rMenB+OMV NZ by percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 against each of the serogroup B indicator strains [ Time Frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination ]
- Evaluation of immune response by hSBA GMTs against each of the serogroups A, C, W-135 and Y [ Time Frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination ]
- Evaluation of immune response by the percentage of subjects with hSBA ≥1:4 and subjects with hSBA ≥1:8 against each of the serogroups A, C, W-135 and Y [ Time Frame: Before the first vaccination, one month after the third vaccination, before the fourth vaccination (13 months of age) and one month after the fourth vaccination ]
- Within-subject Geometric Mean Ratios (GMRs) against each of the serogroup B indicator strains and each of the serogroups A, C, W-135 and Y [ Time Frame: One month after the fourth vaccination versus pre-fourth vaccination ]
- Percentage of subjects with four-fold increases in hSBA titers against each of the serogroup B indicator strains and each of the serogroups A, C, W-135 and Y [ Time Frame: One month after the fourth vaccination over pre-fourth vaccination ]
- Frequencies and percentages of subjects with solicited local and systemic Adverse Events (AEs) [ Time Frame: 7 days (including the day of vaccination) after Day 1, 61, 121, and 301 for all Vaccine Groups ]
- Frequencies and percentages of subjects with any other (unsolicited) AEs, AEs leading to withdrawal and medically attended AEs [ Time Frame: 7 days (including the day of vaccination) after at Day 1, 61, 121, and 301 for all Vaccine ]
- Frequencies and percentages of subjects with SAEs, AEs leading to withdrawal and medically attended AEs [ Time Frame: Throughout the study period (approximately 11 months) ]
Original Secondary Outcome:
- 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 ]
- To assess the immune response of rMenB+OMV NZ and MenACWY when concomitantly administered compared to either alone at
- one month after the fourth vaccination
- one month after the third vaccination
- six months after the third vaccination
- To asses the safety and tolerability of rMenB+OMV NZ and MenACWY when concomitantly administered compared to either alone
- 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 ]
Information By: GlaxoSmithKline
Dates:
Date Received: February 14, 2014
Date Started: June 2014
Date Completion:
Last Updated: February 20, 2017
Last Verified: February 2017