TPP: For the Advance Market Commitment (AMC) for Pneumococcal Conjugate Vaccines- Pneumococcal infections

Target Product Profile (TPP) for the Advance Market Commitment (AMC) for Pneumococcal Conjugate Vaccines

21 February 2008
Indication
The serotypes in the vaccine formulation must cover at least 60% of the invasive disease isolates in the target region, and must include serotypes 1, 5 and 14 which are the most frequent isolates in GAVI eligible countries. 
Intended use

The specifications relate to the public health impact and suitability of the product, covering measures of vaccine efficacy, safety, dosescheduling, presentation and packaging, and represent the minimally acceptable standard a vaccine needs to meet in order to be eligible for AMC support. This table must be read in conjunction with the accompanying Part II TPP Supplementary Information that provides the rationale for the selected criteria, and proposes more advanced product characteristics, that are desirable but not essential

Target population

Minimum/Acceptable: The vaccine must be designed to prevent disease among children <5 years of age and in particularly be effective in those < 2 years of age.

Efficacy
Minimum/Acceptable: The serotypes in the vaccine formulation must cover at least 60% of the invasive disease isolates in the target region, and must include serotypes 1, 5 and 14 which are the most frequent isolates in GAVI eligible countries. Immunogenicity should be demonstrated in accordance with WHO criteria, which are based on non-inferiority to a licensed pneumococcal vaccine as outlined in WHO Recommendations for the production and control of pneumococcal conjugate vaccines. (WHO Technical Report Series, No 927, 2005 and any subsequent published guidance).
Safety
Minimum/Acceptable: The safety and reactogenicity profile should be comparable to, or better than that of the currently licensed pneumococcal conjugate vaccine. Contra-indications should be restricted to known hypersensitivity to any of the vaccine components.
URL
https://www.who.int/publications/m/item/tpp-for-amc-for-pneumococcal-conjugate-vaccines
Product type
Vaccine
Status
Archive
Safety

Formulation/presentation:: Minimum/Acceptable: Liquid formulation with a standard volume of 0.5 ml/dose. The vaccine must be available in mono-dose or low multi-dose presentations. Mono-doses can be either a single dose vial or a non-reusable compact pre-filled device. Low multi-dose presentations should be formulated in compliance with multi-dose vial policy (The use of opened multi-dose vials of vaccine in subsequent immunization sessions, WHO/V&B/00.09). Dose regimen:: Minimum/Acceptable: Vaccine scheduling must be compatible with national infant immunization programmes and consist of not more than 3 doses in the first year of life. The first dose must be shown to be administrable at 6 weeks of life or earlier. Route of administration:: Minimum/Acceptable: Intramuscular or subcutaneous. Stability and storage:: Minimum/Acceptable: The product must be stable at 2-8 °C with a shelf-life of at least 24 months and a vaccine vial monitor should be attached as outlined in Making use of vaccine vial monitors. Flexible vaccine management for polio (WHO/V&B/00.14).

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