In short
Poliovirus (inactivated) type 1 (Mahoney strain) is a component of several authorised combination vaccines used to protect against polio, diphtheria, tetanus, pertussis, and other infections. It appears in four clinical trial records, mainly as part of combination vaccines such as Tetravac, REPEVAX, and Hexyon, and as an auxiliary substance in one trial of ADX-038. The trials are in phases 2 and 3, with enrollments ranging from 45 to 750 participants.
Key points
- Poliovirus (inactivated) type 1 (Mahoney strain) is one of three inactivated poliovirus strains used in combination vaccines.
- It is a component of authorised vaccines including Tetravac, REPEVAX, and Hexyon.
- Clinical trials include Phase 3 studies in pertussis and a Phase 2 trial in meningococcal immunisation.
- The largest trial enrolled 750 participants; the smallest enrolled 45.
- In most records the substance acts as a test or auxiliary vaccine component, never as the sole focus.
- All trials are completed or authorised, with no ongoing recruitment reported.
What is poliovirus (inactivated) type 1 (mahoney strain)?
Poliovirus (inactivated) type 1 (Mahoney strain) is an inactivated (killed) poliovirus used as an antigen in vaccines. It is one of three poliovirus strains — type 1 (Mahoney), type 2 (MEF-1), and type 3 (Saukett) — that together provide protection against poliomyelitis. In the registry records, it appears only as part of fixed combination products, meaning it is not used alone but alongside diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b antigens.
The substance is already authorised as a medicine in several forms. The authorisation holder is Sanofi Pasteur Europe. The European Medicines Agency granted a product-specific waiver for a paediatric investigation plan for this combination of antigens in December 2021.
How does poliovirus (inactivated) type 1 (mahoney strain) work?
The inactivated poliovirus type 1 (Mahoney strain) works by presenting killed virus particles to the immune system. Because the virus is inactivated, it cannot cause polio, but it still triggers the body to produce antibodies against poliovirus type 1. When a vaccinated person later encounters the live virus, these antibodies can neutralise it before it causes disease. This is the same principle used for the type 2 (MEF-1) and type 3 (Saukett) strains included in the same combination vaccines.
Which conditions is it used or studied for?
- Pertussis (whooping cough) — two Phase 3 trials study combination vaccines containing this poliovirus component in the context of pertussis immunity and colonisation.
- Meningococcal immunisation — a Phase 2 trial uses Hexyon, which contains the poliovirus component, as a comparator vaccine in children, toddlers, and infants.
- Complement-mediated kidney disease — a Phase 2 trial of ADX-038 lists Infanrix hexa, containing the poliovirus component, as an auxiliary vaccine.
How is poliovirus (inactivated) type 1 (mahoney strain) given?
The substance is given as a suspension for injection. The route of administration is intramuscular, typically as a 0.5 ml dose. In the trials, it is always part of a combination vaccine such as Tetravac, REPEVAX, Hexyon, or Infanrix hexa, never as a standalone injection.–[4]
What do the clinical trials show?
Four clinical trial records include this substance. In two trials it is a test component (Tetravac and REPEVAX in pertussis studies), and in one trial it is an auxiliary component (Infanrix hexa in a study of ADX-038).
In the first pertussis trial (2024-510787-23-00), Tetravac was used to assess long-term pertussis immunity in 138 children whose mothers were vaccinated during pregnancy. The second pertussis trial (2023-508416-35-00) compared REPEVAX with REVAXIS in 99 healthy adults to see whether booster vaccination reduces colonisation with Bordetella pertussis after controlled human infection. The meningococcal trial (2023-510465-10-00) used Hexyon as a comparator in 750 children, toddlers, and infants. The ADX-038 trial (NCT06989359) used Infanrix hexa as an auxiliary vaccine in 45 participants with complement-mediated kidney disease.
What side effects are known?
The provided supplementary source does not list specific side effects for this poliovirus component. Side effect information for the authorised combination vaccines containing it is available in the product information for each vaccine, but those details are not included in the source data for this page.