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Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325143
First Posted: May 12, 2006
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition Intervention Phase
Haemophilus Influenzae Type b Diphtheria Tetanus Poliomyelitis Acellular Pertussis Biological: DTPa-HBV-IPV/Hib Biological: DTPa-IPV/Hib vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Any Solicited Local and General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses ]
    Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.


Secondary Outcome Measures:
  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects Reporting Any Large Swelling Reactions [ Time Frame: At Month 15, post-booster dose ]
    A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.

  • Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 up to Month 21) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 702
Study Start Date: December 2003
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infanrix Hexa Group
Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
Biological: DTPa-HBV-IPV/Hib
1 intramuscular injection (3rd study vaccine dose)
Other Name: INFANRIX HEXA™
Biological: DTPa-IPV/Hib vaccine
3 intramuscular injections (1st, 2nd and 4th vaccine dose)

Detailed Description:
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   11 Weeks to 17 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Subjects must have been enrolled in the Rota-028 study.
  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.

Exclusion criteria

  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325143


Locations
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 229899
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 217744/100
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 217744/100
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 217744/100
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 217744/100
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 217744/100
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 217744/100
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00325143     History of Changes
Other Study ID Numbers: 217744/100
First Submitted: February 8, 2006
First Posted: May 12, 2006
Results First Submitted: December 13, 2016
Results First Posted: February 7, 2017
Last Update Posted: March 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Diphtheria
Poliomyelitis
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Pentetic Acid
Edetic Acid
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Anticoagulants
Calcium Chelating Agents