Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169442
First received: September 12, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.


Condition Intervention Phase
Hib Disease
Hepatitis B
Diphtheria
Pertussis
Tetanus
Biological: Diphtheria, tetanus, pertussis, hepatitis B & Hib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • In the groups receiving Plain PRP at 10 months of age: one month after the administration of Plain PRP: anti-PRP antibody concentrations [ Designated as safety issue: No ]
  • In the groups receiving DTPw-HBV/Hib or DTPw-HBV + Hib at 15-18 months of age: one month after the administration of the booster: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity in the groups receiving Plain PRP at 10 months of age: prior to receiving Plain PRP: Anti-PRP antibody concentration [ Designated as safety issue: No ]
  • Immunogenicity in the groups receiving DTPw-HBV/Hib or DTPw-HBV + Hib at 15-18 months of age: prior to receiving the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens) [ Designated as safety issue: No ]
  • - Occurrence of solicited symptoms (within the specific follow up period after vaccination) [ Designated as safety issue: No ]
  • - Occurrence of unsolicited symptoms (within the specific follow-up after vaccination) [ Designated as safety issue: No ]
  • - Occurrence of SAEs over the full course of the study. [ Designated as safety issue: No ]

Enrollment: 732
Study Start Date: February 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:
  • Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.
  • Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.
  • Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.
  Eligibility

Ages Eligible for Study:   10 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

For subjects receiving Plain PRP followed by DTPw-HBV:

Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For all subjects:

  • Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
  • Free of obvious health problems as established by medical history and clinical examination

Exclusion criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
  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: NCT00169442

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
GSK Investigational Site
Pasay City, Philippines
GSK Investigational Site
Quezon CIty, Philippines, 1109
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00169442     History of Changes
Other Study ID Numbers: 104065
Study First Received: September 12, 2005
Last Updated: September 29, 2011
Health Authority: Philippines: Department of Health

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014