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Infections, MeningococcalPhase 3NCT00291343

Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

A Phase 3 study testing Tritanrix™- HepB, Hiberix™ and Mencevax™ ACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 2 sites in Philippines.

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

This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. Read more about this study

Who is it for?
Ages 15 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Infections, Meningococcal
What is being tested?
Tritanrix™- HepB, Hiberix™ and Mencevax™ ACWY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
2 sitesPhilippines
Study dates
1 Feb 2006to 15 Mar 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 24 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 24 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 DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.

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; with the exception of oral poliovirus vaccine (OPV).
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
Show all 13Show 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 vaccine.
  • 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.
  • Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.

Trial locations and contacts

2 sites in 1 country.

Philippines2 sites

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Sampaloc, Manila, 1008

Other trials in Philippines

About this study

Official title: Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Read the detailed description

Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.

Blood samples will be drawn from subjects as follows:

  • prior to and one month after the full dose of the Mencevax™ ACWY vaccine.
  • prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
Being tested
Tritanrix™- HepB, Hiberix™, Mencevax™ ACWY
Keywords
hepatitis B, meningococcal vaccine, pertussis, Prophylaxis diphtheria, meningococcal serogroups A and C diseases, tetanus, Haemophilus influenzae type b
Medical subject headings
Meningococcal Infections, Hepatitis B, Whooping Cough, Tetanus, 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 24 months

  • Hiberix™Biological

    One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months

  • Mencevax™ ACWYBiological

    One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months

Study groups in NCT00291343
Study groupRoleWhat they receive
TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUPExperimentalSubjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Receives: Biological: Tritanrix™- HepB; Biological: Hiberix™; Biological: Mencevax™ ACWY
TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUPActive comparatorSubjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Receives: Biological: Tritanrix™- HepB; Biological: Hiberix™; Biological: Mencevax™ ACWY

What is being measured

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

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

    Antibody cut-offs were higher than or equal to (≥) 1:128

    Measured: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).

Secondary outcomes (11)

  1. Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values

    Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128

    Measured: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

  2. Anti-rSBA-MenA, C Antibody Titers

    Antibody titers were expressed as Geometric Mean Titers (GMTs)

    Measured: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

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

    Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).

    Measured: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

  4. Anti-PSA, Anti-PSC Antibody Concentrations

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

    Measured: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

  5. Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs

    The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).

    Measured: Prior to the Mencevax ACWY vaccination at 24-30 Months of age

  6. Anti-HBs Concentrations

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

    Measured: Prior to the Mencevax ACWY vaccination at 24-30 Months of age

  7. Number of Subjects With Vaccine Response for rSBA-Men A, C

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

    Measured: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).

  8. Number of Subjects With Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.

    Measured: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age

  9. Number of Subjects With Solicited General Symptoms

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.

    Measured: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age

  10. 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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.

    Measured: From Day 0 at months 15-24 of age to study end at Months 25-31 of age

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

    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 15-24 Months of age up to Months 25-31 of age

Timeline

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

  1. First posted14 Feb 2006 (estimated)
  2. Study start1 Feb 2006
  3. Primary completion15 Mar 2007
  4. Study completion15 Mar 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
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291343
Sponsor's protocol ID
105239 (mth24-30)
Other IDs
105245
Status last verified
Apr 2017
First submitted
13 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™ ACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 2 sites in Philippines.

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 13 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 2 sites in Philippines. 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 3 Aug 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 Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies (time frame: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).). 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 NCT00291343.

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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