Hepatitis B Vaccine for Meningococcal Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Meningococcal Infections+1 More
Hepatitis B Vaccine - Biological
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new vaccine is non-inferior to the current standard vaccine for infants and toddlers. It is also looking at the antibody response to the new vaccine and comparing it to the current standard.

Eligible Conditions
  • Meningococcal Infections
  • Meningococcal Infection (Healthy Volunteers)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 30 days after the second dose of meningococcal vaccine

Day 30
Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the first dose of meningococcal vaccine
Percentage of participants with hSBA vaccine seroresponse 30 days after the first dose of meningococcal vaccine
Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 30 days after the first dose of meningococcal vaccine
Day 30
Percentage of participants with hSBA vaccine seroresponse 30 days after the second dose of meningococcal vaccine
Day 30
Antibody titers against meningococcal serogroups A, C, Y, and W
Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the second dose of meningococcal vaccine
Antibody titers ≥ 1:8 against meningococcal serogroups A, C,Y, and W 30 days after the second dose of meningococcal vaccine
Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 30 days after the second dose of meningococcal vaccine
Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 30 days after the second of dose of meningococcal vaccine
Month 6
Antibody titers against meningococcal serogroups A, C, Y, and W 6 months after the first dose of meningococcal vaccine
Percentage of participants with hSBA vaccine seroresponse 6 months after the first dose of meningococcal vaccine
Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 6 months after the first dose of meningococcal vaccine

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Group 2
1 of 4
Group 4
1 of 4
Group 1
1 of 4
Group 3
1 of 4

Active Control

Experimental Treatment

1070 Total Participants · 4 Treatment Groups

Primary Treatment: Hepatitis B Vaccine · No Placebo Group · Phase 3

Group 1Experimental Group · 9 Interventions: Hepatitis B Vaccine, Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine, Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Rotavirus Vaccine, Live, Oral, Pentavalent, Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine, Varicella Virus Vaccine Live, Pneumococcal 13-valent Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live, Haemophilus b Conjugate Vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological, Biological, Biological
Group 3
Biological
Experimental Group · 1 Intervention: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine · Intervention Types: Biological
Group 2ActiveComparator Group · 9 Interventions: Hepatitis B Vaccine, Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Rotavirus Vaccine, Live, Oral, Pentavalent, Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine, Varicella Virus Vaccine Live, Pneumococcal 13-valent Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live, Haemophilus b Conjugate Vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological, Biological, Biological
Group 4
Biological
ActiveComparator Group · 1 Intervention: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hepatitis B Vaccine (Recombinant)
FDA approved
Rotavirus vaccine
FDA approved
Varicella zoster vaccine (live/attenuated)
FDA approved
Pneumococcal 13-valent Conjugate Vaccine
2018
Completed Phase 3
~530
Mumps virus strain B level jeryl lynn live antigen
FDA approved
Haemophilus b Conjugate Vaccine
2019
Completed Phase 2
~1050

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after the second dose of meningococcal vaccine

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
381 Previous Clinical Trials
4,958,838 Total Patients Enrolled
48 Trials studying Meningococcal Infections
96,122 Patients Enrolled for Meningococcal Infections
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
790 Previous Clinical Trials
1,630,875 Total Patients Enrolled
14 Trials studying Meningococcal Infections
11,939 Patients Enrolled for Meningococcal Infections

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
was a prerequisite for enrollment For subjects 6 to 7 months of age at enrollment, a documented history of having received 2 doses of DTaP, Hib, IPV, pneumococcal, hepatitis B, and rotavirus vaccines was a prerequisite for enrollment.
The subject and their parent/guardian are able to attend all the scheduled visits and to comply with all the trial procedures.
Subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4) must have received all recommended routine pediatric vaccines.\n
Six to seven months old, or seventeen to nineteen months on the day of the first visit.
The parents or guardian have signed a form stating that they are aware of the risks and benefits of the study, and have given their permission for their child to participate

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
65+100.0%
What site did they apply to?
Investigational Site Number 8400076100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%