AzTrials
AzTrials

Acellular PertussisPhase 3NCT00696423

Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

A Phase 3 study testing Infanrix™ and Hiberix™ in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 3 sites in China.

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

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). Read more about this study

Who is it for?
Ages 18 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Acellular Pertussis, Diphtheria, Tetanus
What is being tested?
Infanrix™ and Hiberix™
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
467 participants
Where
3 sitesChina
Study dates
7 Jun 2008to 26 Jul 2008
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 18 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 should be enrolled in the study.
  • Subjects should have completed the full three-dose primary vaccination course in study 104567.
  • A male or female child between, and including, 18 and 24 months of age at the time of the booster 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.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster 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 the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study.
  • History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
Show all 20Show 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(s).
  • Major congenital defects or serious chronic illness.
  • History of any progressive neurological disorders or seizures.
  • Acute disease and/or fever at time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of any of the following adverse events (AEs) after previous administration of a diphtheria-tetanus-pertussis (DTP) vaccine:
  • Hypersensitivity reaction due to any component of the vaccine.
  • Encephalopathy.
  • Fever ≥ 40.0 °C (axillary temperature) within 48 hours of vaccination.
  • Collapse or shock-like state within 48 hours of vaccination.
  • Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
  • Seizures with or without fever occurring within 3 days of vaccination.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • GSK Investigational Site

    Liucheng County, Guangxi, 545200

  • GSK Investigational Site

    Mengshan

  • GSK Investigational Site

    Wuzhou

Other trials in China

About this study

Official title: Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.

Being tested
Infanrix™, Hiberix™
Keywords
Infanrix/Hib, Chinese children
Medical subject headings
Diphtheria, Tetanus

What participants receive

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

  • Infanrix™Biological

    Intramuscular injection, one dose

  • Hiberix™Biological

    Intramuscular injection, one dose

Study groups in NCT00696423
Study groupRoleWhat they receive
Infanrix/Hib Single Injection GroupExperimentalSubjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
Receives: Biological: Infanrix™; Biological: Hiberix™
Infanrix + Hiberix Separate Injection GroupActive comparatorSubjects received two separate injections, one of Infanrix™ and one of Hiberix™.
Receives: Biological: Infanrix™; Biological: Hiberix™

What is being measured

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

  1. Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations

    Geometric mean concentrations are given in microgram per milliliter (μg/mL).

    Measured: One month after booster vaccination

  2. Anti-diphtheria Toxoid Antibody Concentrations

    Geometric mean concentrations are given in international Unit per milliliter (IU/mL).

    Measured: One month after booster vaccination

  3. Anti-tetanus Toxoid Antibody Concentrations

    Geometric mean concentrations are given in IU/mL.

    Measured: One month after booster vaccination

  4. Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations

    Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

    Measured: One month after booster vaccination

  5. The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies

    Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.

    Measured: One month after booster vaccination

Secondary outcomes (8)

  1. Anti-PRP Antibody Concentrations

    Geometric mean concentrations are given in μg/mL.

    Measured: Before booster vaccination

  2. Anti-diphtheria Toxoid Antibody Concentrations

    Geometric mean concentrations are given in IU/mL.

    Measured: Before booster vaccination

  3. Anti-tetanus Toxoid Antibody Concentrations

    Geometric mean concentrations are given in IU/mL.

    Measured: Before booster vaccination

  4. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Geometric mean concentrations are given in EL.U/mL.

    Measured: Before booster vaccination

  5. The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies

    Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.

    Measured: Before booster vaccination

  6. Number of Subjects Reporting Solicited Local and General Symptoms

    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.

    Measured: During the 4-day follow-up period after booster vaccination

  7. Number of Subjects Reporting Unsolicited Adverse Events (AE)

    An AE is 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.

    Measured: During the 31-day follow-up period after booster vaccination

  8. Number of Subjects Reporting Serious Adverse Events (SAE)

    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

    Measured: During the 31-day follow-up period after booster vaccination

Timeline

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

  1. First posted12 Jun 2008 (estimated)
  2. Study start7 Jun 2008
  3. Primary completion26 Jul 2008
  4. Study completion26 Jul 2008

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00696423
Sponsor's protocol ID
111535
Status last verified
Oct 2016
First submitted
5 Jun 2008
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 Infanrix™ and Hiberix™ in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 3 sites in China.

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 20 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 China. 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 26 Aug 2009). 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?

Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations (time frame: One month after booster vaccination). The study lists 5 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 NCT00696423.

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.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in