Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01294605
First received: February 10, 2011
Last updated: February 17, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus and Pertussis |
Biological: Boostrix™ (dTpa) Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM) Biological: Ditanrix™ Adult, TedivaxTM (Td) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the third dose (Month 7) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after each dose (Months 1, 2 and 7) ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general symptoms [ Time Frame: Within 15 days (day 0 -14) after each vaccine dose. ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms [ Time Frame: Within 31 days (day 0-30) after each vaccine dose. ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: Until 31 days (day 0-30) after the last vaccine dose. ] [ Designated as safety issue: No ]
- Occurrence of large local swelling reported [ Time Frame: Within 15 days (day 0-14) after each vaccine dose ] [ Designated as safety issue: No ]
- Use of concomitant medication taken [ Time Frame: Within 31 days (day 0-30) after each vaccine dose ] [ Designated as safety issue: No ]
| Enrollment: | 460 |
| Study Start Date: | April 2003 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Biological: Boostrix™ (dTpa)
Intramuscular, 3 doses
|
| Experimental: Group B |
Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Intramuscular, single dose
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 2 doses
|
| Active Comparator: Group C |
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 3 doses
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
- A male or female adult >= 40 years of age
- Written informed consent to be obtained from the subject prior to study entry
- No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- subject should not be pregnant or plan to become pregnant.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- 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 within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions
- Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition
Contacts and Locations More Information
Publications:
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01294605 History of Changes |
| Other Study ID Numbers: | 263855/034 |
| Study First Received: | February 10, 2011 |
| Last Updated: | February 17, 2011 |
| Health Authority: | Netherlands: Minister van VWS Medische Technologie Spain: Agencia Española del Medicamento y Productos Sanitarios Belgium: Agence Fédérale des Medicaments et des Produits de la Santé |
Keywords provided by GlaxoSmithKline:
|
DTPa Td IPV |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection |
Respiratory Tract Diseases Clostridium Infections Pentetic Acid Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antidotes Protective Agents Physiological Effects of Drugs Iron Chelating Agents |
ClinicalTrials.gov processed this record on May 19, 2013