Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00829010

Purpose

The purposes of this study:

To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age.
To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.
This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.

Condition	Intervention	Phase
Pneumococcal Diseases	Biological: rotavirus Biological: measles Biological: Pneumococcal vaccine GSK1024850A Biological: Tritanrix-HepB/Hib	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Primary and Booster Vaccination Course in Human Immunodeficiency Virus (HIV) Infected Infants, HIV Exposed Uninfected Infants and Unexposed Uninfected Infants Receiving the Pneumococcal Vaccine GSK 1024850A.

Resource links provided by NLM:

MedlinePlus related topics: AIDS Measles

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Concentration of antibodies against the investigational vaccine above the protocol specified cut-off value [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Concentration of antibodies against components of the co-administered vaccine [ Time Frame: One month after primary and booster immunization ] [ Designated as safety issue: No ]
Concentration of antibodies against the co-administered rotavirus vaccine [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
Concentration of antibodies against the co-administered measles vaccine [ Time Frame: One month after the first and second vaccine dose ] [ Designated as safety issue: No ]
Occurrence of salivary antibodies against selected common bacterial protein antigens [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of each solicited adverse event [ Time Frame: Within 4 days after each vaccination ] [ 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: Following screening or after the first vaccination, as applicable, up to study end. ] [ Designated as safety issue: No ]
Concentration of antibodies against components of the investigational vaccine for additional parameters [ Time Frame: One month following primary and booster vaccination and up to study end ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HIV+/+ Group: Experimental Infants born from a HIV positive mother and confirmed as HIV infected	Biological: rotavirus Oral, 2 doses Biological: measles Intramuscular injection, 2 doses Biological: Pneumococcal vaccine GSK1024850A Intramuscular injection, administered as 3 or 4 doses Biological: Tritanrix-HepB/Hib Intramuscular injection, 4 doses
HIV- (3+1) Group: Experimental Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected randomized according to vaccination schedule	Biological: rotavirus Oral, 2 doses Biological: measles Intramuscular injection, 2 doses Biological: Pneumococcal vaccine GSK1024850A Intramuscular injection, administered as 3 or 4 doses Biological: Tritanrix-HepB/Hib Intramuscular injection, 4 doses
HIV- (2+1) Group: Experimental Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected randomized according to vaccination schedule	Biological: rotavirus Oral, 2 doses Biological: measles Intramuscular injection, 2 doses Biological: Pneumococcal vaccine GSK1024850A Intramuscular injection, administered as 3 or 4 doses Biological: Tritanrix-HepB/Hib Intramuscular injection, 4 doses
HIV+/- Group: Experimental Infants born from a HIV positive mother and confirmed as HIV exposed uninfected	Biological: rotavirus Oral, 2 doses Biological: measles Intramuscular injection, 2 doses Biological: Pneumococcal vaccine GSK1024850A Intramuscular injection, administered as 3 or 4 doses Biological: Tritanrix-HepB/Hib Intramuscular injection, 4 doses
HIV- (EPI) Group: Experimental Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected randomized according to vaccination schedule	Biological: rotavirus Oral, 2 doses Biological: measles Intramuscular injection, 2 doses Biological: Pneumococcal vaccine GSK1024850A Intramuscular injection, administered as 3 or 4 doses Biological: Tritanrix-HepB/Hib Intramuscular injection, 4 doses

Detailed Description:

This protocol posting has been updated according to Protocol amendment 1, December 08

Eligibility

Ages Eligible for Study:	6 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female subjects between, and including 6-10 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)/guardian(s) of the child/ward.
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

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.
A family history of hereditary immunodeficiency other than HIV infection.
Major congenital defects or serious chronic illness other than HIV infection.
For HIV infected infants: Moderately and severely symptomatic: stages III and IV according to latest version of WHO classification.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or Streptococcus pneumoniae.
History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Acute disease at the time of enrolment.
Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts.
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.
Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of vaccination).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829010

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

South Africa
GSK Investigational Site	Recruiting
Soweto, South Africa, 2040

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111634
Study First Received:	January 22, 2009
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00829010 History of Changes
Health Authority:	South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine
Pneumococcal disease
Immunogenicity
Safety

Primary vaccination
Booster vaccination
Human Immunodeficiency Virus

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 10, 2009