Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00148941
First received: September 7, 2005
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
"The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator."
| Condition | Intervention | Phase |
|---|---|---|
|
Poliomyelitis Diphtheria Pertussis Prophylaxis Tetanus |
Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety, Immunogenicity&Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine vs Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Admd as Booster Doses to Healthy Children 4-6 Yrs, Each Co-admd With Merck's MMR Vaccine |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Lot-to-lot consistency: immunogenicity one month post-vaccination:
- Anti-D antibody concentrations, anti-T antibody concentrations, anti-PT antibody concentrations, anti-FHA antibody concentrations, anti-PRN antibody concentrations, anti-poliovirus type 1, type 2 and type 3 antibody titers.
- Non-inferiority: immunogenicity one month post-vaccination:
- Anti-D booster response, anti-T booster response, anti-PT booster response, anti-FHA booster response, anti-PRN booster response, anti-poliovirus type 1, type 2 and type 3 antibody titers
- Safety:
- incidence of increased circumferential swelling at the DTaP-containing vaccine injection site within 4 days after vaccination.
Secondary Outcome Measures:
- Immunogenicity one month after vaccination:
- Anti-D antibody concentration, anti-T antibody concentration, anti-PT antibody concentration, anti-FHA antibody concentration, anti-PRN antibody concentration, anti-poliovirus type 1, type 2 and type 3 booster response
- Safety:
- Safety and reactogenicity of the study vaccines in all groups during the entire study period
| Enrollment: | 4087 |
| Study Start Date: | January 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
- Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine.
- Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections.
- Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit.
- A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).
Eligibility| Ages Eligible for Study: | 4 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or female child between and including 4 and 6 years of age at the time of vaccination.
- Subjects should have received 4 doses of GSK DTaP (primary vaccination course with booster dose in the second year of life) and 3 doses of IPV during the first 2 years of life and vaccination against measles, mumps, and rubella in the second year of life.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
- Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period.
- Administration of immunoglobulins and/or blood products within 3 months prior to vaccination or planned administration during the study period.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148941
Locations
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| Antioch, California, United States, 94509 | |
| GSK Investigational Site | |
| Daly City, California, United States, 94015 | |
| GSK Investigational Site | |
| Fairfield, California, United States, 94533 | |
| GSK Investigational Site | |
| Fremont, California, United States, 94538 | |
| GSK Investigational Site | |
| Fresno, California, United States, 93726 | |
| GSK Investigational Site | |
| Hayward, California, United States, 94545 | |
| GSK Investigational Site | |
| North Pleasanton, California, United States, 94588 | |
| GSK Investigational Site | |
| Oakland, California, United States, 94611 | |
| GSK Investigational Site | |
| Redwood City, California, United States, 94063 | |
| GSK Investigational Site | |
| Richmond, California, United States, 94801 | |
| GSK Investigational Site | |
| Roseville, California, United States, 95661 | |
| GSK Investigational Site | |
| Sacramento, California, United States, 95825 | |
| GSK Investigational Site | |
| Sacramento, California, United States, 95823 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94115 | |
| GSK Investigational Site | |
| San Jose, California, United States, 95119 | |
| GSK Investigational Site | |
| San Ramon, California, United States, 94583 | |
| GSK Investigational Site | |
| Santa Clara, California, United States, 95051 | |
| GSK Investigational Site | |
| Santa Rosa, California, United States, 95403 | |
| GSK Investigational Site | |
| Vacaville, California, United States, 95688 | |
| GSK Investigational Site | |
| Vallejo, California, United States, 94589 | |
| GSK Investigational Site | |
| Walnut Creek, California, United States, 94596 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43214 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Mechanicsville, Virginia, United States, 23111 | |
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: | NCT00148941 History of Changes |
| Other Study ID Numbers: | 213503/048 |
| Study First Received: | September 7, 2005 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Poliomyelitis Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases |
Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on May 16, 2013