Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01175083
First received: August 3, 2010
Last updated: April 17, 2014
Last verified: June 2013
  Purpose

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.


Condition Intervention Phase
Infections, Streptococcal
Biological: GSK1024850A (SynflorixTM)
Biological: Tritanrix-HepB/Hib
Biological: Polio Sabin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immune responses to components of the investigational vaccine, (<6S and <6NS groups) [ Time Frame: One month after primary vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the immune responses to components of the investigational vaccine, for additional parameters (<6S, 7-11S, <6NS and 7-11NS groups) [ Time Frame: Prior to and one month after primary vaccination ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccine, for additional parameters (<6S, 7-11S, <6NS and 7-11NS groups) [ Time Frame: Prior to and one month after booster dose ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccine, for additional parameters (12-23S and 12-23NS groups) [ Time Frame: Prior to first dose, prior to and one month after second dose ] [ Designated as safety issue: No ]
  • Evaluation of immune responses to components of the co-administered vaccine (<6S and <6NSgroups): [ Time Frame: Prior to and one month after primary vaccination, prior to, and one month after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of each solicited adverse event [ Time Frame: Within 4 days after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From first vaccination up to 31 Days after the last vaccination ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: <6S
Children below 6 months of age with sickle cell disease
Biological: GSK1024850A (SynflorixTM)
2, 3 or 4 intramuscular injection
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: Polio Sabin
4 oral doses
Other Name: OPV
Active Comparator: <6NS
Healthy children below 6 months of age
Biological: GSK1024850A (SynflorixTM)
2, 3 or 4 intramuscular injection
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: Polio Sabin
4 oral doses
Other Name: OPV
Experimental: 7-11S
Children between 7-11 months of age with sickle cell disease
Biological: GSK1024850A (SynflorixTM)
2, 3 or 4 intramuscular injection
Active Comparator: 7-11NS
Healthy children between 7-11 months of age
Biological: GSK1024850A (SynflorixTM)
2, 3 or 4 intramuscular injection
Experimental: 12-23S
Children between 12-23 months of age with sickle cell disease
Biological: GSK1024850A (SynflorixTM)
2, 3 or 4 intramuscular injection
Active Comparator: 12-23NS
Healthy children between 12-23 months of age
Biological: GSK1024850A (SynflorixTM)
2, 3 or 4 intramuscular injection

Detailed Description:

This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.

  Eligibility

Ages Eligible for Study:   8 Weeks to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
  • A male or female between, and including:

    • 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or
    • 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or
    • 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
  • Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.

Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):

  • Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (<6S group) or electrophoresis (7-11S and 12-23S groups).
  • Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context

Additional inclusion criteria for healthy children (<6NS, 7-11NS and 12-23NS groups):

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Children with negative diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.

Exclusion Criteria:

  • Child in care
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
  • 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).
  • Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital malformations.
  • History of any neurological disorders or seizures.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Birth weight below 1500g.
  • Serious chronic illness other than SCD.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Additional exclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):

• Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).

Additional exclusion criteria for healthy children (<6 NS, 7-11NS and 12-23NS groups):

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175083

Locations
Burkina Faso
GSK Investigational Site
Ouagadougou, Burkina Faso
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01175083     History of Changes
Other Study ID Numbers: 114056
Study First Received: August 3, 2010
Last Updated: April 17, 2014
Health Authority: Burkina Faso: Ministere de la Santé

Keywords provided by GlaxoSmithKline:
Immunogenicity
Booster vaccination
Catch-up vaccination
Pneumococcal vaccine
Pneumococcal disease
Sickle cell disease
Safety

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014