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Vaccine

Meningitis Vaccines for Infants

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month after the 4th vaccination (day 331) versus pre-4th vaccination (day 301)
Awards & highlights

Study Summary

This trial is testing a new meningitis vaccine in infants to see if it is safe and effective.

Who is the study for?
Healthy infants aged 6 to 12 weeks, born full-term and with no immune system issues or severe allergies. They must not have received certain vaccines or blood products from birth, nor have chronic illnesses or conditions that could increase study risks.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Bexsero (meningococcal group B vaccine) given alongside PCV13 (pneumococcal conjugate vaccine) and other routine infant vaccines to see if they work well together without causing harm.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like pain and swelling, fever, irritability, sleepiness, appetite changes, headache, joint pain, diarrhea, vomiting and muscle aches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 6 and 12 weeks old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month after the 3rd vaccination (day 151)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month after the 3rd vaccination (day 151) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibody Geometric Mean Concentrations (GMC) using electrochemiluminescence (ECL) assay for each of the 13 PCV13 antigens
Percentages of subjects with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs
Percentages of subjects with all unsolicited AEs
+7 more
Secondary outcome measures
Antibody GMCs using ECL for each of the 13 PCV13 serotypes
Pertussis vaccine
GMCs for Anti-HBsAg antibodies
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MenB+PCV GroupExperimental Treatment8 Interventions
Approximately 800 subjects enrolled in this group will receive rMenB+OMV NZ (Bexsero) concomitantly with PCV13 (Prev-nar13) and other RIV (Pediarix, Hiberix, Rotarix, M-M-R II, Varivax) at 2, 4, 6 and 12 months of age. Subjects who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose will either receive PCV13 or PCV20 at 12 months of age (Visit 5).
Group II: Placebo+PCV GroupPlacebo Group8 Interventions
Approximately 400 subjects enrolled in this group will receive PCV13 concomitantly with placebo and other RIV at 2, 4, 6 and 12 months of age. Subjects who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose will either receive PCV13 or PCV20 at 12 months of age (Visit 5).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prevnar13
2016
Completed Phase 4
~2460
Varivax
2012
Completed Phase 3
~20430
Rotarix
2003
Completed Phase 4
~11900
Hiberix
2006
Completed Phase 3
~3790
M-M-R II
2012
Completed Phase 3
~27980
Pediarix
2004
Completed Phase 3
~127860

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,066,252 Total Patients Enrolled
11 Trials studying Meningococcal Disease
7,724 Patients Enrolled for Meningococcal Disease
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,142,730 Total Patients Enrolled
7 Trials studying Meningococcal Disease
5,443 Patients Enrolled for Meningococcal Disease

Media Library

Bexsero (rMenB+OMV NZ) (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03621670 — Phase 3
Meningococcal Disease Research Study Groups: Placebo+PCV Group, MenB+PCV Group
Meningococcal Disease Clinical Trial 2023: Bexsero (rMenB+OMV NZ) Highlights & Side Effects. Trial Name: NCT03621670 — Phase 3
Bexsero (rMenB+OMV NZ) (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03621670 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients accepted in this trial?

"This clinical trial is recruiting infants that are under 12 weeks old and have already surpassed the 6 week mark."

Answered by AI

What outcomes does this clinical trial hope to see?

"The primary outcome of this trial is to assess the percentage of subjects with unsolicited AEs at 1 month after the 3rd vaccination. Secondary outcomes include GMCs against 3 pertussis antigens and percentages of subjects with hSBA antibody titers ≥5 and ≥8 for each of the 4 selected meningococcal B strains. The trial will also measure hSBA Geometric Mean Ratios (GMR) of GMTs over pre-4th vaccination for the four selected meningococcal B strains."

Answered by AI

How many test subjects are included in this research?

"That is correct. The clinical trial in question, which was initially posted on 7/27/2018, is still recruiting patients. 30 different sites are looking to enroll a total of 1200 individuals."

Answered by AI

Are there any available positions for participants in this trial?

"That is correct. Active recruitment is taking place for this trial, which was originally posted on July 27th, 2018. The latest update to the posting occurred on November 2nd, 20212. They are looking for 1200 individuals across 30 sites."

Answered by AI

Does the research on Prevnar13 have a long history?

"Prevnar13 was first studied in 2006 at Duke University Medical Center. 738 clinical trials have been completed since then and, as of now, there are 80 active recruiting studies. A large number of these latter studies take place in Provo, Utah."

Answered by AI

Would it be accurate to say that this study is taking place in many hospitals across Canada?

"To participate in this trial, you must go to one of the 30 sites currently enrolling patients. Some of these locations include Provo, Las Vegas and Fall River. By choosing a location close to you, you can reduce how much travelling is required."

Answered by AI

Has the FDA cleared Prevnar13 for use?

"There is some efficacy data and multiple rounds of safety data, making Prevnar13 a 3 on our Power scale."

Answered by AI

What infections does Prevnar13 help to prevent?

"Prevnar13, while commonly used to treat mumps, can also help patients infected with human poliovirus 1, viral hepatitis b, and herpes zoster."

Answered by AI

Could I potentially join this clinical research project?

"The eligibility criteria for this clinical trial includes infants aged 6 weeks to 12 weeks who have contracted meningococcal infections. Around 1200 participants will be enrolled in the study."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
2018. "Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03621670.
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~81 spots leftby Oct 2024
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