Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00317109
First received: February 3, 2006
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

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


Condition Intervention Phase
Hepatitis B
Meningococcal Infection
Diphtheria
Pertussis
Haemophilus Infection
Tetanus
Biological: Tritanrix™- HepB
Biological: Hiberix™
Biological: Mencevax™ ACW
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • SBA-MenA and SBA-MenC titres [ Time Frame: One month after the administration of the Mencevax™ ACW vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SBA-MenA, SBA-MenC and SBA-MenW titres [ Time Frame: Prior to & after the administration of the Mencevax™ ACW vaccine ] [ Designated as safety issue: No ]
  • Anti-PSA, Anti-PSC and Anti-PSW concentrations [ Time Frame: Prior to & after the administration of the Mencevax™ ACW vaccine ] [ Designated as safety issue: No ]
  • Booster/Vaccine response to meningococcal antigens [ Time Frame: One month after the administration of the Mencevax™ ACW vaccine ] [ Designated as safety issue: No ]
  • Occurrence of fever [ Time Frame: During the 4-day follow-up period after the booster dose of the Tritanrix™-HepB/Hiberix™ vaccine ] [ Designated as safety issue: Yes ]
  • Occurrence of local and general solicited symptoms [ Time Frame: During the 4-day follow-up period after the administration of the Mencevax™ ACW vaccine ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after the administration of the Mencevax™ ACW vaccine ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: April 2006
Estimated Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC primed Group Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Active Comparator: AC unprimed Group Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

Detailed Description:

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

  Eligibility

Ages Eligible for Study:   15 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study (CPMS N° 759346/007).

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Axillary temperature ≥ 37.5°C at the time of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
  • Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
  • Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317109

Locations
South Africa
GSK Investigational Site
Brits, South Africa, 0250
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208
GSK Investigational Site
Rooihuiskraal, South Africa, 0145
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00317109     History of Changes
Other Study ID Numbers: 104756
Study First Received: February 3, 2006
Last Updated: November 21, 2012
Health Authority: South Africa: Department of Health

Keywords provided by GlaxoSmithKline:
meningococcal serogroups A and C diseases
tetanus
hepatitis B
pertussis
Haemophilus influenzae type b
meningococcal vaccine
Prophylaxis diphtheria

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Hepatitis
Hepatitis A
Hepatitis B
Meningococcal Infections
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Neisseriaceae Infections
Bordetella Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on April 17, 2014