Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01529645
First received: February 6, 2012
Last updated: March 21, 2013
Last verified: March 2013
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Purpose
This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and Tdap (acellular pertussis, Tetanus and Diphtheria) in healthy subjects 18 to 40 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Pertussis Whooping Cough Tetanus Lockjaw Diphtheria |
Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine Biological: Licensed comparator Tdap booster vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Phase I, Randomized, Controlled, Observer-Blind, Dose-Ranging Study of Acellular Pertussis and Tetanus-Diptheria-Acellular Pertussis Booster Vaccine in Adults Ages 18 to 40 Years. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- assess the safety profiles of all study vaccines against comparator, as measured by local and systemic reactions, patient reported outcomes and adverse events/serious adverse events (AEs/SAEs) [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]
- select up to 4 vaccine dose candidates for further study based on immunogenicity responses to antigen components at Day 30 provided the safety profiles are comparable. [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]
- evaluate antibody titers for Pertussis and Seroresponse rates for Diphtheria, and Tetanus antigens prior to and 1 month following vaccination. [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- evaluate Seroresponse rates for Pertussis antigens and antibody titers to Diphtheria, and Tetanus Prior to and 1 month following vaccination. [ Time Frame: 30 days after vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 420 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1: aP booster |
Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 2: aP booster |
Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 3: aP booster |
Biological: Different antigen doses of Acellular Pertussis (aP) vaccine and Tetanus-Diphtheria (Td) booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 4: Tdap booster |
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 5: Tdap booster |
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 6: Tdap booster |
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 7: Tdap booster |
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 8: Tdap booster |
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Experimental: Group 9: Tdap booster |
Biological: Different antigen doses of Acellular Pertussis (aP), Tetanus (T) and Diphtheria (D) vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
| Active Comparator: Group 10: Licensed Tdap booster |
Biological: Licensed comparator Tdap booster vaccine
Administered intramuscularly in the upper deltoid region of the subject's non-dominant arm
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female individuals 18 to 40 years of age
Exclusion Criteria:
- Recent exposure to Tetanus, Diphtheria or pertussis disease or vaccination with T, D or pertussis (aP or whole cell) containing vaccine.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01529645 History of Changes |
| Other Study ID Numbers: | V113_01, 2011-000688-28 |
| Study First Received: | February 6, 2012 |
| Last Updated: | March 21, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Novartis:
|
pertussis booster vaccine tetanus diphtheria in adults |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Tetanus Tetany 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 Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013