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NCT01978093 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
A Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT01978093: Completed Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline.
NCT01978093 is a Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b that has completed, run by GlaxoSmithKline. The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01978093, a Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.
Primary Outcome
Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will f
Conditions Studied
Interventions
- BIOLOGICAL Hib-MenCY-TT (MenHibrix®)
- BIOLOGICAL Pediarix®
- BIOLOGICAL Rotarix®
- BIOLOGICAL Prevnar 13®
- BIOLOGICAL PedvaxHIB®
Study Locations (20)
California
- GSK Investigational Site - Fresno
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Paramount
- GSK Investigational Site - Pleasanton
- GSK Investigational Site - Roseville
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Jose
- GSK Investigational Site - Santa Clara
- GSK Investigational Site - Walnut Creek
Arkansas
- GSK Investigational Site - Fayetteville
- GSK Investigational Site - Jonesboro
Massachusetts
- GSK Investigational Site - Fall River
- GSK Investigational Site - Woburn
Michigan
- GSK Investigational Site - Niles
- GSK Investigational Site - Stevensville
Ohio
- GSK Investigational Site - Cleveland
- GSK Investigational Site - Dayton
Alabama
- GSK Investigational Site - Birmingham
North Carolina
- GSK Investigational Site - Raleigh
Pennsylvania
- GSK Investigational Site - Hermitage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2014-02-01 |
| Est. Completion | 2016-03-18 |
| Phase | Phase 3 |
What the finished NCT01978093 record still lists
NCT01978093 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Neisseria Meningitidis appearing as the primary indexed condition, and to 5 interventions - of which Hib-MenCY-TT (MenHibrix®) is the first listed.
NCT01978093 names 20 study sites across 8 states, led by California, Arkansas, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01978093 about?
NCT01978093 is a clinical study titled "Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age". The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.
What is the current status of trial NCT01978093?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2014-02-01. Estimated completion is 2016-03-18.
What conditions does trial NCT01978093 study?
This clinical trial studies the following conditions: Neisseria Meningitidis, Haemophilus Influenzae Type b.
What interventions are being tested in trial NCT01978093?
The interventions under investigation include: Hib-MenCY-TT (MenHibrix®) (BIOLOGICAL), Pediarix® (BIOLOGICAL), Rotarix® (BIOLOGICAL), Prevnar 13® (BIOLOGICAL), PedvaxHIB® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01978093?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01978093 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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