AzTrials
AzTrials

Infections, StreptococcalPhase 3NCT00911144

Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

A Phase 3 study testing GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A), Wyeth-Lederle's Prevenar™ and GSK Biologicals' Hiberix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 14 sites in South Korea.

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

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914. Read more about this study

Who is it for?
Ages 12 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Infections, Streptococcal
What is being tested?
GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A), Wyeth-Lederle's Prevenar™ and GSK Biologicals' Hiberix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
14 sitesSouth Korea
Study dates
11 Jun 2009to 11 Jan 2010
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 12 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • A male or female between, and including, 12-18 months of age at the time of booster vaccination.
  • Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
  • Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • 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) within 30 days preceding the vaccination, or planned use during the study period.
  • 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
Show all 13Show fewer
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
  • Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Acute disease at the time of enrolment.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • GSK Investigational Site

    Ansan, 425-707

  • GSK Investigational Site

    Bucheon-Si, GyeongGi-do,, 420-767

  • GSK Investigational Site

    Daejeon, 301-723

  • GSK Investigational Site

    Gyeonggi-do, 411-706

  • GSK Investigational Site

    GyeongSangNam-do, 641-560

  • GSK Investigational Site

    Iksan, 570-711

  • GSK Investigational Site

    Jeju City, 690-121

  • GSK Investigational Site

    Jeonju Jeonbuk, 561-712

  • GSK Investigational Site

    Pusan, 602-739

  • GSK Investigational Site

    Seoul, 130-702

  • GSK Investigational Site

    Seoul, 150-719

  • GSK Investigational Site

    Seoul, 158-710

  • GSK Investigational Site

    Suwon City, Gyeonggi-do, 442-723

  • GSK Investigational Site

    Wonju-si Kangwon-do, 220-701

Other trials in South Korea

About this study

Official title: Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

Being tested
GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A), Wyeth-Lederle's Prevenar™, GSK Biologicals' Hiberix™
Keywords
Safety, Pneumococcal vaccine, Immunogenicity, Pneumococcal disease, Booster vaccination
Medical subject headings
Streptococcal Infections, Pneumococcal Infections

What participants receive

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

  • GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)Biological

    Also called Pneumococcal vaccine GSK1024850A

    Intramuscular injection, administered as a single dose

  • Wyeth-Lederle's Prevenar™Biological

    Intramuscular injection, administered as a single dose

  • GSK Biologicals' Hiberix™Biological

    Also called Hib

    Intramuscular injection, administered as a single dose

Study groups in NCT00911144
Study groupRoleWhat they receive
Synflorix GroupExperimentalSubjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Receives: Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A); Biological: GSK Biologicals' Hiberix™
Prevenar GroupActive comparatorSubjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Receives: Biological: Wyeth-Lederle's Prevenar™; Biological: GSK Biologicals' Hiberix™

What is being measured

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

  1. Number of Subjects Reporting Grade 3 Adverse Events

    Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.

    Measured: Within 31 days (Day 0 - Day 30) after booster vaccination.

Secondary outcomes (9)

  1. Number of Subjects Reporting Solicited Symptoms

    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.

    Measured: Within 4 days (Days 0 to 3) after booster vaccination

  2. Number of Subjects Reporting Unsolicited Adverse Events

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

    Measured: Within 31 days (Days 0 to 30) after booster vaccination

  3. Number of Subjects Reporting Serious Adverse Events

    Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    Measured: After booster vaccination up to study end (Month 0 to Month 1)

  4. Concentration of Antibodies Against Vaccine Pneumococcal Serotypes

    Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL).

    Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

    Measured: One month after booster vaccination (Month 1)

  5. Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

    Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

    Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

    Measured: One month after booster vaccination (Month 1)

  6. Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A

    Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.

    Measured: One month after booster vaccination (Month 1)

  7. Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A

    Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

    Measured: One month after booster vaccination (Month 1)

  8. Concentration of Antibodies Against Protein D (PD)

    Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).

    Measured: One month after booster vaccination (Month 1)

  9. Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)

    Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.

    Measured: One month after booster vaccination (Month 1)

Timeline

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

  1. First posted1 Jun 2009 (estimated)
  2. Study start11 Jun 2009
  3. Primary completion11 Jan 2010
  4. Study completion11 Jan 2010

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
Single blind
Who is masked
Participant
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911144
Sponsor's protocol ID
112933
Status last verified
Oct 2016
First submitted
28 May 2009
Last updated
20 Sep 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

  • Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.

    PubMed 21817957

  • Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.

  • Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.

  • Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A), Wyeth-Lederle's Prevenar™ and GSK Biologicals' Hiberix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 14 sites in South Korea.

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 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Korea. 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 19 Jan 2011). 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 Reporting Grade 3 Adverse Events (time frame: Within 31 days (Day 0 - Day 30) after booster vaccination.). 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 NCT00911144, which also lists 4 linked publications.

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 20 Sep 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