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Infections, MeningococcalPhase 3NCT00317109

Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

A Phase 3 study testing Tritanrix™- HepB, Hiberix™ and Mencevax™ ACW in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 sites in South Africa.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135… Read more about this study

Who is it for?
Ages 15 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Infections, Meningococcal
What is being tested?
Tritanrix™- HepB, Hiberix™ and Mencevax™ ACW
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
3 sitesSouth Africa
Study dates
19 Apr 2006to 17 May 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 15 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study (CPMS N° 759346/007).

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
Show all 16Show fewer
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Axillary temperature ≥ 37.5°C at the time of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
  • Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
  • Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.

Trial locations and contacts

3 sites in 1 country.

South Africa3 sites

  • GSK Investigational Site

    Brits, 0250

  • GSK Investigational Site

    Ga-Rankuwa, 0208

  • GSK Investigational Site

    Rooihuiskraal, 0145

Other trials in South Africa

About this study

Official title: Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Read the detailed description

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

Being tested
Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
Keywords
meningococcal serogroups A and C diseases, tetanus, hepatitis B, pertussis, Haemophilus influenzae type b, meningococcal vaccine, Prophylaxis diphtheria
Medical subject headings
Meningococcal Infections, Tetanus, Hepatitis B, Whooping Cough, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tritanrix™- HepBBiological

    One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months

  • Hiberix™Biological

    One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months

  • Mencevax™ ACWBiological

    One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

Study groups in NCT00317109
Study groupRoleWhat they receive
AC primed GroupExperimentalNot described
Receives: Biological: Tritanrix™- HepB; Biological: Hiberix™; Biological: Mencevax™ ACW
AC unprimed GroupActive comparatorNot described
Receives: Biological: Tritanrix™- HepB; Biological: Hiberix™; Biological: Mencevax™ ACW

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies

    Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.

    Measured: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)

Secondary outcomes (14)

  1. Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs

    Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.

    Measured: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

  2. Anti-rSBA-MenA, C, W-135 Antibody Titers

    Antibody titers were expressed as geometric mean titers (GMTs).

    Measured: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

  3. Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values

    Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).

    Measured: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

  4. Anti-PSA and Anti-PSC Antibody Concentrations

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

    Measured: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31

  5. Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values

    Antibody concentrations were ≥ 0.3 µg/mL.

    Measured: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

  6. Anti-PSW Antibody Concentrations

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

    Measured: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

  7. Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values

    Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).

    Measured: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine

  8. Anti-HBs Antibody Concentrations

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

    Measured: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine

  9. Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135

    Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.

    Measured: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

  10. Number of Subjects With Fever

    Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.

    Measured: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine

  11. Number of Subjects With Solicited Local Symtoms

    Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.

    Measured: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine

  12. Number of Subjects With Solicited General Symptoms

    Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.

    Measured: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine

  13. Number of Subjects With Unsolicited Adverse Events (AEs)

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

    Measured: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine

  14. Number of Subjects With Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Measured: From Months 15-18 and up to Months 25-31 post vaccination

Timeline

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

  1. First posted24 Apr 2006 (estimated)
  2. Study start19 Apr 2006
  3. Primary completion1 May 2007
  4. Study completion17 May 2007

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
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317109
Sponsor's protocol ID
104756
Status last verified
Jan 2017
First submitted
3 Feb 2006
Last updated
6 Jun 2018
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tritanrix™- HepB, Hiberix™ and Mencevax™ ACW in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 sites in South Africa.

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 5 inclusion and 16 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Africa. 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?

Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies (time frame: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)). 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 NCT00317109.

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 6 Jun 2018.

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