AzTrials
AzTrials

Haemophilus Influenzae Type bPhase 3NCT00263653

Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197

A Phase 3 study testing Haemophilus influenzae type b- and meningococcal (vaccine) in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 16 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed… Read more about this study

Who is it for?
Ages 13 to 14 monthsHealthy volunteers can take part
What is being tested?
Haemophilus influenzae type b- and meningococcal (vaccine)
Type of treatment
Vaccines
How many people
297 participants
Where
16 sitesSpain
Study dates
Mar 2005to Sep 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.
  • Previously completed 3-dose primary vaccination with a MenC-CRM197 vaccine, and Hib (given as part of a combined DTPa-containing vaccine) with at least 6 months between the administration of the third doses and the study entry.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the study vaccine, or planned use during the study period.
  • Previous vaccination against OR history of H. influenzae type b (Hib) and/or meningococcal serogroup C disease and/or measles, mumps or rubella OR known exposure to measles, mumps or rubella within 30 days prior to the start of the present study.
  • 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.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including neomycine

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Spain16 sites

  • GSK Investigational Site

    Almería, 04007

  • GSK Investigational Site

    Almería, 04009

  • GSK Investigational Site

    Antequera/Málaga, 29200

  • GSK Investigational Site

    Aravaca, 28023

  • GSK Investigational Site

    Blanes

  • GSK Investigational Site

    Burgos, 09005

  • GSK Investigational Site

    Lleida, 25006

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Mollet Del Valles/Barcelona, 08100

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Sant Adriá de Beyós, Barcelona, 08930

  • GSK Investigational Site

    Sant Eugenia de Berga, Barcelona, 08519

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Vélez-Málaga

Other trials in Spain

About this study

Official title: Study to Evaluate the Safety, Reactogenicity & Immunogenicity of a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™, vs Hib-MenC or Priorix™ Only, in Toddlers (13-14 m) Primed With 3 Doses of Hib (as Part of a DTPa -Containing Vaccine) & MenC-CRM197 Conjugate Vaccines.

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa -containing vaccine) and MenC-CRM197.

Read the detailed description

This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as active controls. Two blood samples are taken: before and one month after vaccination. Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain

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.

  1. Any grade 3 solicited symptoms (d 0 - 3)

Secondary outcomes (1)

  1. Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionMar 2005
  4. Study completionSep 2005

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00263653
Sponsor's protocol ID
103954
Status last verified
Sep 2016
First submitted
8 Dec 2005
Last updated
21 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.

Publications

  • Carmona A, Miranda M, Barrio F, De Vicente A, Mares J, Munoz E, Diez-Delgado J, Alonso A, Gimenez-Sanchez F, Merino J, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 103954 Study Group. Reactogenicity and immunogenicity of combined Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine booster dose coadministered with measles, mumps, and rubella vaccine. Pediatr Infect Dis J. 2010 Mar;29(3):269-71. doi: 10.1097/INF.0b013e3181c15977.

    PubMed 19952860

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 Haemophilus Influenzae Type b and Neisseria Meningitidis, 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 6 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 21 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?

Any grade 3 solicited symptoms (d 0 - 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00263653, which also lists 1 linked publication.

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 21 Sep 2016; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in