Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine
Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster
2 other identifiers
interventional
709
2 countries
16
Brief Summary
The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) compared to NeisVac-C™ given with Infanrix™ hexa. The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2006
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 7, 2016
October 1, 2016
7 months
May 16, 2006
October 6, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
SBA-MenC titre
One month after the second dose of the Primary Vaccination Phase.
Anti-PRP concentration
One month after the second dose of the Primary Vaccination Phase
Secondary Outcomes (8)
SBA-MenC titres
One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PRP concentrations
One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PSC concentrations
One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.
Anti-HBs concentrations
One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Occurrence of local solicited adverse events.
During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
- +3 more secondary outcomes
Study Arms (2)
Group Hib-MenC
EXPERIMENTALSubjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines.
Group NeisVac-C
ACTIVE COMPARATORSubjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.
Interventions
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
Eligibility Criteria
You may qualify if:
- Primary Phase:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- healthy male or female subject between, and including, 6 and 12 weeks of age at the time of the first vaccination, born after a gestation period between and including 36 and 42 weeks.
- Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Booster Phase:
- Participation in primary phase of study.
You may not qualify if:
- Primary Phase:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG.
- Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease
- History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Previous booster vaccination with Hib and/or MenC and/or DTP containing and/or IPV containing and/or HepB containing vaccine(s).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (16)
GSK Investigational Site
Espoo, 02100, Finland
GSK Investigational Site
Helsinki, 00100, Finland
GSK Investigational Site
Helsinki, 00930, Finland
GSK Investigational Site
Jarvenpaa, 04400, Finland
GSK Investigational Site
Kotka, 48100, Finland
GSK Investigational Site
Lahti, 15140, Finland
GSK Investigational Site
Oulu, 90100, Finland
GSK Investigational Site
Pori, 28120, Finland
GSK Investigational Site
Tampere, 33200, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Vantaa, 01300, Finland
GSK Investigational Site
Vantaa, 01600, Finland
GSK Investigational Site
Bari, Apulia, 70124, Italy
GSK Investigational Site
Lodi, Lombardy, 26900, Italy
GSK Investigational Site
Sassari, Sardinia, 07100, Italy
GSK Investigational Site
Ragusa, Sicily, 97100, Italy
Related Publications (1)
Vesikari T, Forsten A, Desole MG, Ferrera G, Caubet M, Mesaros N, Boutriau D. A combined Haemophilus influenzae type B Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus at 3, 5 and 11 months of age: results of an open, randomized, controlled study. Pediatr Infect Dis J. 2013 May;32(5):521-9. doi: 10.1097/INF.0b013e31827e22e3.
PMID: 23190785BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2006
First Posted
May 18, 2006
Study Start
April 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.