Phase 1
N=315
Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)
Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT02382913 ↗Enrolled (actual)
315
Serious AEs
—
Results posted
Feb 2016
Primary outcome: Primary: Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. — 28; 31; 48; 18 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- aP booster (Biological); TdaP booster (Biological); Licensed TdaP booster (Boostrix®) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. |
28; 31; 48; 18; 43; 54 | — |
| PRIMARY Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. |
17; 22; 34; 18; 41; 32 | — |
| PRIMARY Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. |
31; 31; 43; 18; 51; 48 | — |
| PRIMARY Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. |
7.21; 7.63; 11; 4.28; 2.93; 1.50 | — |
| PRIMARY Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. |
3.70; 3.58; 6.67; 4.28; 1.05; 1.03 | — |
| PRIMARY Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. |
3.40; 3.82; 5.90; 4.28; 1.02; 0.98 | — |
Summary
The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113\_01 study.
There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn.
No vaccine was administered and no safety data was collected in this study.
Eligibility Criteria
Inclusion Criteria
- Healthy individuals previously enrolled in V113\_01 trial, who completed the study following study protocol and who received the appropriate booster vaccine per group assignment
- Individuals who voluntarily gave written informed consent after the nature of the study was explained according to local regulatory requirements, prior to study entry
- Individuals who could comply with study procedures including follow-up
Exclusion Criteria
- Clinical conditions representing a contraindication to blood draw.
- Abnormal function of the immune system resulting from:
- Clinical conditions
- Systemic administration of corticosteroids per oral (PO)/ intravenous (IV)/ intramuscular (IM) for more than 14 consecutive days within 90 days prior to informed consent.
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- Received immunoglobulins or any blood products within 180 days prior to informed consent.
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent
- Study personnel as an immediate family or household member
- Any other clinical condition that, in the opinion of the investigator, could interfere with the results of the study or pose additional risk to the subject due to participation in the study
Data sourced from ClinicalTrials.gov (NCT02382913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.