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Infections, RotavirusPhase 3NCT00533507

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

A Phase 3 study testing Synflorix, Infanrix hexa and Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 3 sites in Taiwan.

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 immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a… Read more about this study

Who is it for?
Ages 6 to 8 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Rotavirus
What is being tested?
Synflorix, Infanrix hexa and Rotarix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
3 sitesTaiwan
Study dates
18 Sep 2007to 6 Jun 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 6 to 8 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female subjects between, and including 6-8 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s) or guardian(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Who cannot join

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
  • 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.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Show all 15Show fewer
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (e.g. Hepatitis B and Bacillus Calmette-Guérin (BCG)).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 105

  • GSK Investigational Site

    Taoyuan Hsien

Other trials in Taiwan

About this study

Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Read the detailed description

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

Being tested
Synflorix, Infanrix hexa, Rotarix
Keywords
Pneumococcal vaccine., Pneumococcal disease, Safety, Immunogenicity, Primary vaccination
Medical subject headings
Rotavirus Infections, Pneumococcal Infections

What participants receive

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

  • SynflorixBiological

    Also called Pneumococcal conjugate vaccine GSK1024850A

    Intramuscular injection, 3 doses.

  • Infanrix hexaBiological

    Also called DTPa-HBV-IPV/Hib

    Intramuscular injection, 3 doses.

  • RotarixBiological

    Also called HRV vaccine

    Oral, 2 doses.

Study groups in NCT00533507
Study groupRoleWhat they receive
Synflorix groupExperimentalSubjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
Receives: Biological: Synflorix; Biological: Infanrix hexa; Biological: Rotarix

What is being measured

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

  1. Concentration of Anti-Protein D Antibodies

    Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

    Measured: One month after the third dose

  2. Concentration of Anti-Pneumococcal Antibodies

    Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL).

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

    Measured: One month after the third dose

Secondary outcomes (14)

  1. Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value

    Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

    Measured: Before the first dose (pre) and one month after (post) the third dose

  2. Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL).

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

    Measured: Before the first dose (pre) and one month after (post) the third dose

  3. Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

    Measured: One month after the third dose

  4. Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value

    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.

    Measured: One month after the third dose

  5. Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value

    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.

    Measured: One month after the third dose

  6. Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value

    Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).

    Measured: One month after the third dose

  7. Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value

    Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).

    Measured: One month after the third dose

  8. Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value

    Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).

    Measured: One month after the third dose

  9. Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value

    Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).

    Measured: One month after the third dose

  10. Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value

    Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.

    Measured: One month after the third dose

  11. Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value

    Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).

    Measured: Four months after the administration of the second dose of Rotarix™ vaccine

  12. Number of Subjects Reporting Solicited Symptoms

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

    Measured: During the 4-day (Day 0-3) period after each dose

  13. 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 (Day 0-30) period after each dose

  14. 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 disability/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: Up to one month after the third dose

Timeline

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

  1. First posted21 Sep 2007 (estimated)
  2. Study start18 Sep 2007
  3. Primary completion1 Jun 2008
  4. Study completion6 Jun 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
Single group
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00533507
Sponsor's protocol ID
109861
Status last verified
Oct 2016
First submitted
20 Sep 2007
Last updated
8 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.

Publications

  • Lin TY, Lu CY, Chang LY, Chiu CH, Huang YC, Bock HL, Tang H, Francois N, Moreira M, Schuerman L, Huang LM. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan. J Formos Med Assoc. 2012 Sep;111(9):495-503. doi: 10.1016/j.jfma.2011.07.014. Epub 2012 Mar 18.

    PubMed 23021506

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Synflorix, Infanrix hexa and Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 3 sites in Taiwan.

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 15 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 8 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 Taiwan. 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 24 Jul 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?

Concentration of Anti-Protein D Antibodies (time frame: One month after the third dose). The study lists 2 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 NCT00533507, 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 8 Jun 2018.

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