Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204658
First received: September 16, 2010
Last updated: May 30, 2013
Last verified: April 2013
  Purpose

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.


Condition Intervention Phase
Pneumococcal Disease
Haemophilus Influenza Infections
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Biological: Synflorix
Biological: Prevenar 13
Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of fever >40.0°C (rectal temperature) with causal relationship to vaccination [ Time Frame: Within 7 days (Day 0-6) following at least one dose of the primary vaccination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of each solicited local and general adverse events [ Time Frame: Within 7 days (Day 0-6) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0-30) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From the first vaccine dose up to study end ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccines [ Time Frame: One month post-dose 3, before booster dose and one month post-booster dose ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the co-administered DTPa-HBV-IPV/Hib vaccine [ Time Frame: One month post-dose 3, before booster dose and one month post-booster dose ] [ Designated as safety issue: No ]

Enrollment: 576
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Children receiving pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
Four doses will be co-administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Experimental: Group 2
Children receiving pneumococcal vaccine GSK2189242A (formulation 2)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
Four doses will be co-administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Active Comparator: Group 3
Children receiving Synflorix
Biological: Synflorix
Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
Four doses will be co-administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Active Comparator: Group 4
Children receiving Prevenar 13
Biological: Prevenar 13
Four doses will be administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.
Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
Four doses will be co-administered intramuscularly, at approximately 2, 3, 4 and 12-15 months of age.

  Eligibility

Ages Eligible for Study:   6 Weeks to 14 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
  • 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 vaccination against S. pneumoniae since birth.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • 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 any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature >= 38.0°C on rectal setting or >= 37.5°C on oral or axillary setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204658

Locations
Germany
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Berlin, Germany, 13055
Poland
GSK Investigational Site
Debica, Poland, 39-200
GSK Investigational Site
Krakow, Poland, 31-503
GSK Investigational Site
Poznan, Poland, 6-709
GSK Investigational Site
Warszawa, Poland, 01-184
GSK Investigational Site
Wroclaw, Poland, 50345
Sweden
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Örebro, Sweden, SE-702 11
GSK Investigational Site
Östersund, Sweden, SE-831 83
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01204658     History of Changes
Other Study ID Numbers: 113994
Study First Received: September 16, 2010
Last Updated: May 30, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Sweden: Läkemedelsverket - Medical Products Agency
Poland: Ministry of Health: Ewa Kopacz
Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Haemophilus influenzae
Streptococcus pneumoniae
immunogenicity
Pneumococcal vaccine
infants
safety

Additional relevant MeSH terms:
Influenza, Human
Haemophilus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pentetic Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents

ClinicalTrials.gov processed this record on April 16, 2014