Neisseria MeningitidisPhase 3NCT00323050
Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
A Phase 3 study testing Haemophilus influenzae type b- and meningococcal (vaccine) in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 16 sites in Spain.
Trial summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three… Read more about this study
- Who is it for?
- Ages 13 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Haemophilus Influenzae Type b
- What is being tested?
- Haemophilus influenzae type b- and meningococcal (vaccine)
- Type of treatment
- Vaccines
- How many people
- 468 participants
- Where
- 16 sitesSpain
- Study dates
- Nov 2004to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female between, and including, 13 and 14 months of age
- Having participated in the primary vaccination study 217744/097.
Who cannot join
- Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- History of any neurologic disorders or seizures
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
GSK Investigational Site
Alcorcón, 28922
GSK Investigational Site
Almeira, 4009
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08950
GSK Investigational Site
Basurto/Bilbao, 48013
GSK Investigational Site
Burgos, 09005
GSK Investigational Site
Getafe, 28905
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
Valladolid, 47010
GSK Investigational Site
Vélez-Málaga
About this study
Official title: Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
Read the detailed description
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
- Being tested
- Haemophilus influenzae type b- and meningococcal (vaccine)
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemophilus influenzae type b- and meningococcal (vaccine)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.
Secondary outcomes (4)
Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128
Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3
Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.
SAEs for whole study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startNov 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria MeningitidisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323050
- Sponsor's protocol ID
- 102547
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2005
- Last updated
- 16 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec
- ClinicalTrials.gov ID
- NCT00323050
- Acronym / sponsor ID
- 102547
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
Detailed description
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy male or female between, and including, 13 and 14 months of age
- Having participated in the primary vaccination study 217744/097.
Key exclusion criteria (4 listed)
- Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- History of any neurologic disorders or seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haemophilus influenzae type b- and meningococcal (vaccine) | Biological | – |
Primary outcome
Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.
4 secondary outcomes
Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128
Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3
Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.
SAEs for whole study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Neisseria Meningitidis
Not yet recruitingObservational study
Metagenomic Analysis of the Pharynx in High Risk Partners
Gonorrhea, Neisseria Gonorrhea
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
RecruitingPhase 1
A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
Neisseria Meningitidis Serogroup B
RecruitingPhase 4
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
Neisseria Meningitidis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haemophilus influenzae type b- and meningococcal (vaccine) in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 16 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.