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Vaccine

Hepatitis B Vaccine* [Recombinant] *as applicable for Pneumococcal Vaccination

Phase 2
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 150; day 300; day 330
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of two pneumococcal vaccines in infants and toddlers.

Eligible Conditions
  • Pneumococcal Vaccination
  • Hepatitis B Vaccination
  • Pertussis Vaccination
  • Diphtheria Vaccination
  • Tetanus Vaccine
  • Mumps Vaccination
  • Haemophilus Influenzae Type b Vaccination
  • Polio Vaccination
  • Measles Vaccination
  • Rubella Vaccination
  • Chickenpox Vaccine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 150; day 300; day 330
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 150; day 300; day 330 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants* *as applicable
GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
+7 more
Secondary outcome measures
GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when DTaP - IPV// Hib vaccine is co- administered with SP0202 or Prevnar 13 in toddlers
GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when co- administered with SP0202 or Prevnar 13 in toddlers
Antibodies
+10 more

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Group 7Experimental Treatment6 Interventions
Four doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group II: Group 6Experimental Treatment6 Interventions
Four doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group III: Group 5Experimental Treatment6 Interventions
Four doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Group IV: Group 3Experimental Treatment2 Interventions
One dose of SP0202-VII and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group V: Group 2Experimental Treatment2 Interventions
One dose of SP0202-VI and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group VI: Group 1Experimental Treatment2 Interventions
One dose of SP0202-IIb and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group VII: Group 4Active Control2 Interventions
One dose of Prevnar 13 and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Group VIII: Group 8Active Control6 Interventions
Four doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Measles, Mumps, and Rubella Virus Vaccine Live
2020
Completed Phase 3
~2330
Hepatitis B Vaccine* [Recombinant] *as applicable
2020
Completed Phase 2
~860
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
2020
Completed Phase 2
~860
Rotavirus Vaccine, Live, Oral, Pentavalent
2020
Completed Phase 3
~3380
Pneumococcal Conjugate Vaccine formulation 2
2020
Completed Phase 2
~860
Varicella Virus Vaccine Live
2020
Completed Phase 3
~2390
Pneumococcal Conjugate Vaccine formulation 1
2020
Completed Phase 2
~860
Pneumococcal Conjugate Vaccine formulation 3
2020
Completed Phase 2
~860

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,091,128 Total Patients Enrolled
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,127 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
862 Previous Clinical Trials
2,018,986 Total Patients Enrolled

Frequently Asked Questions

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

Is this experiment actively enrolling test subjects?

"Correct. On clinicaltrials.gov, it is apparent that this medical trial has commenced its recruitment process since May 22nd 2020 and was last updated on October 14th 2022. Approximately 840 participants need to be recruited from 93 distinct sites."

Answered by AI

Am I eligible to be involved in this experiment?

"This trial is recruiting 840 infants, aged 42 days to 15 months old, who have already contracted diphtheria. Necessary requirements include attending all scheduled sessions and adhering to the protocol as well being born at full term with a birthweight of 5.5 pounds or greater; receiving 3 doses of Prevnar 13 and other DTaP-IPV/Hib antigens prior to enrolment; and being between 12 -15 months on the day of their first visit OR 42 -89 days on that same date."

Answered by AI

Are there any prior studies involving the Hepatitis B Vaccine [Recombinant], if applicable?

"The initial research on Hepatitis b Vaccine* [Recombinant] *as applicable was conducted in 2007 at Children's Hospital of Geneva (HUG). Subsequently, 844 studies were completed with 77 additional trials currently ongoing. Notably, Missoula, Montana is a major hub for these investigations."

Answered by AI

To what ailments is the Hepatitis B Vaccine* [Recombinant] *as applicable typically prescribed for?

"The Hepatitis b Vaccine* [Recombinant] *as applicable is primarily used to target mumps, but can also be utilized in the treatment of human poliovirus 1, poliomyelitis, and gastroenteritis."

Answered by AI

Are there numerous US venues hosting this research project?

"There are a plethora of clinical trial locations available, including Boeson Research-Site Number:8400004 in Missoula, Lincoln Pediatric Group-Site Number:8400125 in Lincoln and Investigational Site Number :8400137 in Annapolis. Altogether there are 93 sites for this study."

Answered by AI

Does the FDA sanction the use of Recombinant Hepatitis B Vaccine?

"Due to a lack of efficacy data, our team at Power has assigned the Hepatitis b Vaccine* [Recombinant] *as applicable a safety score of 2. This is based on it being in Phase 2 clinical trials and having some supporting evidence for its safety profile."

Answered by AI

What are the primary aims of this experiment?

"This study's primary objective, assessed around Day 30 of the trial, is to identify how many participants present with injection site and systemic reactions. There are also two secondary objectives - evaluating the geometric mean (GM) ratio for serotype specific opsonophagocytic titers in both toddlers and infants as well as determining how many infants have a serotype-specific OPA titer above a predefined threshold value."

Answered by AI

Is the age limit for participation in this research project restricted to below 35 years of age?

"This research initiative is accepting patients aged between 42 days and 15 months old. There are 61 studies for minors, and 180 trials for senior citizens."

Answered by AI

How many participants are taking part in this research trial?

"Affirmative. Information present on clinicaltrials.gov indicates that this examination is in the process of recruiting participants, having first been posted on May 22nd 2020 and last modified October 14th 2022. The trial requires 840 people to be recruited from 93 distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Investigational Site Number :8400066
Investigational Site Number :1240002
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Investigational Site Number :8400066: < 24 hours
Average response time
  • < 1 Day
~173 spots leftby Apr 2025