Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Wks of Age - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00533507

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Disease	Biological: Infanrix hexa. Biological: Rotarix. Biological: Pneumococcal conjugate vaccine GSK1024850A.	Phase III

MedlinePlus related topics: Diphtheria Tetanus

Drug Information available for: Infanrix hexa Heptavalent pneumococcal conjugate vaccine RotaTeq Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Concentrations of antibodies against vaccine pneumococcal serotypes and protein D. [ Time Frame: One month after the administration of the third dose of pneumococcal conjugate vaccine GSK1024850A. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Concentrations of antibodies against vaccine pneumococcal serotypes. [ Time Frame: Prior to vaccination. ] [ Designated as safety issue: No ]
Concentrations of antibodies against protein D. [ Time Frame: Prior to vaccination. ] [ Designated as safety issue: No ]
Opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: One month after the administration of the third dose of pneumococcal conjugate vaccine GSK1024850A. ] [ Designated as safety issue: No ]
Concentrations of antibodies against vaccine pneumococcal serotypes. [ Time Frame: One month after the administration of the third dose of pneumococcal conjugate vaccine GSK1024850A. ] [ Designated as safety issue: No ]
Concentrations of antibodies against cross-reactive pneumococcal serotypes. [ Time Frame: One month after the administration of the third dose of pneumococcal conjugate vaccine GSK1024850A. ] [ Designated as safety issue: No ]
Opsonophagocytic activity against cross-reactive pneumococcal serotypes [ Time Frame: One month after the administration of the third dose of pneumococcal conjugate vaccine GSK1024850A. ] [ Designated as safety issue: No ]
Anti-diphtheria and anti-tetanus toxoids, anti-PRP, anti-pertussis, anti-HBs antibody concentrations and anti-polio type 1, 2 and 3 titres. [ Time Frame: One month after the administration of the third dose of DTPa-HBV-IPV/Hib vaccine (Infanrix hexa). ] [ Designated as safety issue: No ]
Anti-rotavirus IgA antibody concentrations. [ Time Frame: Four months after the administration of the second dose of HRV vaccine (Rotarix) vaccine. ] [ Designated as safety issue: No ]
Occurrence of solicited local symptoms. [ Time Frame: Within 4 days after each vaccination dose. ] [ Designated as safety issue: Yes ]
Occurrence of solicited general symptoms. [ Time Frame: Within 4 days after each vaccination dose. ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days after each vaccination dose. ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events. [ Time Frame: Following the administration of the first dose of study vaccine throughout the entire study period up. ] [ Designated as safety issue: Yes ]

Enrollment:	230
Study Start Date:	September 2007
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
10Pn group: Experimental Subjects receiving pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) at 1.5-3-6 months of age, and co-administered with HRV (Rotarix) at 1.5-3 months of age.	Biological: Infanrix hexa. Intramuscular injection, 3 doses. Biological: Rotarix. Oral, 2 doses. Biological: Pneumococcal conjugate vaccine GSK1024850A. Intramuscular injection, 3 doses.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	6 Weeks to 8 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533507

Locations

Taiwan
GSK Investigational Site
Taoyuan Hsien, Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 105

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109861
Study First Received:	September 20, 2007
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00533507 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine.
Pneumococcal disease
Immunogenicity
Safety
Primary vaccination

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009