Infections, MeningococcalPhase 2NCT00135486
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
A Phase 2 study testing MenC-TT and Hib-MenC-TT in people with Infections, Meningococcal, run by GlaxoSmithKline.
Trial summary
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus… Read more about this study
- Who is it for?
- Ages 8 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- MenC-TT and Hib-MenC-TT
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jan 2003
- Phase
- Phase 2
- 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 8 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.
Who cannot join
- Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- Planned administration/administration of a vaccine not foreseen in the study since birth.
- 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, allergic disease or reactions likely to be exacerbated by any component of the vaccine
About this study
Official title: Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.
Read the detailed description
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.
- Conditions
- Infections, Meningococcal
- Being tested
- MenC-TT, Hib-MenC-TT
- Keywords
- Haemophilus Influenzae type b/Meningococcal vaccine, Prophylaxis meningococcal serogroup C disease, Hib diseases
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenC-TTBiological
Hib-MenC-TTBiological
Also called MenC-TT
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
Measured: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations
Measured: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations
Measured: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
Measured: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Measured: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL
Measured: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL
Measured: Prior to and one month after the 3rd vaccine dose
Vaccine response to pertussis toxoid (PT)
Measured: Prior to 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Measured: Prior to 3rd vaccine dose
Anti-poliovirus types 1, 2 and 3 antibody titers
Measured: Prior to and one month after the 3rd vaccine dose
Occurrence of solicited local injection site symptoms
Measured: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of solicited systemic symptoms
Measured: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of unsolicited non-serious adverse events (AEs)
Measured: Within one month (Day 0 30) after each vaccination
Occurrence of any serious adverse events (SAEs)
Measured: Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose
Vaccine response to pertussis toxoid (PT)
Measured: One month after the 3rd vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Measured: Prior to 3rd vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Measured: One month after the 3rd vaccine dose
Vaccine response to pertactin (PRN)
Measured: Prior to 3rd vaccine dose
Vaccine response to pertactin (PRN)
Measured: One month after the 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Measured: One month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Measured: Prior to 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Measured: One month after the 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Measured: Prior to 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Measured: One month after the 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Measured: Prior to 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Measured: One month after the 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Measured: Prior to 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Measured: One month after the 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Measured: Prior to 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Measured: One month after the 3rd vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startMar 2002
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, MeningococcalStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT00135486
- Sponsor's protocol ID
- 711202/001
- Status last verified
- Sep 2016
- First submitted
- 25 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.
Publications
Schmitt HJ, Maechler G, Habermehl P, Knuf M, Saenger R, Begg N, Boutriau D. Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 2007 Apr;14(4):426-34. doi: 10.1128/CVI.00377-06. Epub 2007 Feb 7.
PubMed 17287313
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, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life
- ClinicalTrials.gov ID
- NCT00135486
- Acronym / sponsor ID
- 711202/001
- Conditions
- Infections, Meningococcal
- Keywords
- Haemophilus Influenzae type b/Meningococcal vaccine, Prophylaxis meningococcal serogroup C disease, Hib diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 26 Aug 2005 (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 primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.
Detailed description
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.
Key exclusion criteria (5 listed)
- Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- Planned administration/administration of a vaccine not foreseen in the study since birth.
- 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, allergic disease or reactions likely to be exacerbated by any component of the vaccine
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 |
|---|---|---|
| MenC-TT | Biological | – |
| Hib-MenC-TTAlso: MenC-TT | Biological | – |
Primary outcome
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
Time frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations
Time frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations
Time frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
Time frame: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Time frame: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL
Time frame: Prior to and one month after the 3rd vaccine dose
Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL
Time frame: Prior to and one month after the 3rd vaccine dose
Vaccine response to pertussis toxoid (PT)
Time frame: Prior to 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Time frame: Prior to 3rd vaccine dose
Anti-poliovirus types 1, 2 and 3 antibody titers
Time frame: Prior to and one month after the 3rd vaccine dose
Occurrence of solicited local injection site symptoms
Time frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of solicited systemic symptoms
Time frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of unsolicited non-serious adverse events (AEs)
Time frame: Within one month (Day 0 30) after each vaccination
Occurrence of any serious adverse events (SAEs)
Time frame: Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose
Vaccine response to pertussis toxoid (PT)
Time frame: One month after the 3rd vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Time frame: Prior to 3rd vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Time frame: One month after the 3rd vaccine dose
Vaccine response to pertactin (PRN)
Time frame: Prior to 3rd vaccine dose
Vaccine response to pertactin (PRN)
Time frame: One month after the 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Time frame: One month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Time frame: Prior to 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Time frame: One month after the 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Time frame: Prior to 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Time frame: One month after the 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Time frame: Prior to 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Time frame: One month after the 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Time frame: Prior to 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Time frame: One month after the 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Time frame: Prior to 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Time frame: One month after the 3rd vaccine dose
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.
- Derived from this study: PubMed 17287313Schmitt HJ, Maechler G, Habermehl P, Knuf M, Saenger R, Begg N, Boutriau D. Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 2007 Apr;14(4):426-34. doi: 10.1128/CVI.00377-06. Epub 2007 Feb 7.
- 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.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenC-TT and Hib-MenC-TT in people with Infections, Meningococcal, run by GlaxoSmithKline.
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 1 inclusion and 5 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers (time frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses). The study lists 30 primary outcomes in all. 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 NCT00135486, 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 16 Sep 2016.