Last updated: 07/17/2024 15:15:07

Evaluate safety and immunogenicity of a booster dose of pneumococcal conjugate vaccine in preterm born infants.

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GSK study ID
109621
See study documents
Clinicaltrials.gov ID
NCT00609492
See results summary
EudraCT ID
2007-000596-42
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety, reactogenicity and immunogenicity following booster dose of GSK Biologicals´ pneumococcal conjugate vaccine when co-administered with a booster dose of Infanrix-IPV/Hib in preterm born children at 16-18 months of age
Trial description: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. 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 =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting fever with rectal temperature above (>) 39.0 degrees Celsius (°C)

Timeframe: Within 4-days (Day 0-3) after booster vaccination

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 4-days (Day 0-3) after booster vaccination

Number of subjects with any and Grade 3 solicited general symptoms

Timeframe: Within 4-days (Day 0-3) after booster vaccination

Number of subjects with unsolicited adverse events (AEs)

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

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the active phase of the study (Month 0 to Month 1)

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)

Number of seropositive subjects for anti-pneumococcal serotypes

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

Number of seroprotected subjects against anti-pneumococcal serotypes

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody concentrations against pneumococcal serotypes

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seropositive subjects for pneumococcal cross-reactive serotypes 6A and 19A

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seropositive subjects for protein D antibodies (Anti-PD)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody concentrations against protein D (Anti-PD)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seroprotected subjects against anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody concentrations against anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seroprotected subjects against anti-polyribosyl-ribitol phosphate (anti-PRP)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody concentrations against anti-polyribosyl-ribitol-phosphate (Anti-PRP)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

Number of seropositive subjects for anti-pertussis toxoid (Anti-PT), anti- filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody concentrations against anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of subjects with vaccine response for anti-PT, anti-FHA and anti-PRN antibodies

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seroprotected subjects against anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3)

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody titers against anti-polio type 1, 2 and 3

Timeframe: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Antibody concentrations against anti-hepatitis B surface antigen (HBs)

Timeframe: Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seropositive subjects for opsonophagocytic activity (OPA) against pneumococcal serotypes

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Opsonophagocytic activity (OPA) against pneumococcal serotypes

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Number of seropositive subjects for opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A

Timeframe: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

Interventions:
Biological/vaccine: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)
Biological/vaccine: Infanrix™-IPV/Hib
Enrollment:
245
Observational study model:
Not applicable
Primary completion date:
2008-10-11
Time perspective:
Not applicable
Clinical publications:
Omenaca F et al. (2011) Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 128(2):e290-e298.
Omenaca F et al. Booster vaccination of preterm-born children with 10-valent pneumococcal non-typeable haemophilus influenzae protein D-conjugate vaccine (PHiD-CV): antibody responses and safety. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 18-22 November 2009.
Omenaca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
January 2008 to March 2009
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
16 - 18 months
Accepts healthy volunteers
Yes
  • 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.
  • A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
Inclusion and exclusion criteria
Inclusion criteria:
  • 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.
  • A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
  • A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
  • History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures or progressive neurological disease
  • Acute disease at the time of enrolment.
  • Febrile illness defined as oral, axillary or tympanic temperature < 37.5°C / rectal temperature < 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Burgos, Spain, 09005
Status
Study Complete
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Location
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
Status
Study Complete
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Location
GSK Investigational Site
Athens, Greece, 11527
Status
Study Complete
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Location
GSK Investigational Site
Thessaloniki, Greece, 54636
Status
Study Complete
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Location
GSK Investigational Site
Madrid, Spain, 28047
Status
Study Complete
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Location
GSK Investigational Site
Ioannina, Greece, 452 21
Status
Study Complete
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Location
GSK Investigational Site
Rio/Patras, Greece, 26500
Status
Terminated/Withdrawn
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2008-10-11
Actual study completion date
2009-30-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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