100 Clinical Results associated with Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)

100 Translational Medicine associated with Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)

100 Patents (Medical) associated with Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)

Literatures (Medical) associated with Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)

01 Dec 2021·BMJ Evidence-Based Medicine

Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe?

Article

Author: Petersen, Sesilje B ; Gluud, Christian

The Merck Sharp & Dohme Corp aluminium adjuvant ‘amorphous aluminium hydroxyphosphate sulfate’ (AAHS), primarily used in the Gardasil vaccines against human papilloma virus, has been criticised for lack of evidence for its safety. Documentation from Danish authorities and answers from the European Medicines Agency (EMA) suggest that AAHS may not have been sufficiently evaluated. Documentation from the Danish Medicines Agency shows discrepancies in the trial documents of two prelicensure clinical trials with Gardasil in 2002 and 2003. For both trials, the Agency seems to have authorised potassium aluminium sulfate as the adjuvant and not AAHS. In addition, the participants in the trial launched in 2002 were informed that the comparator was saline, even though the comparator was AAHS in an expedient consisting of L-histidine, polysorbate-80, sodium borate and sodium chloride. According to the EMA, AAHS was first introduced in Europe in 2004 as the adjuvant in Procomvax, a vaccine against the hepatitis B virus andHaemophilus influenzatype b. The EMA reports that AAHS was introduced without any prelicensure safety evaluation. The adjuvant is described by the company to be both physically and functionally distinct from all other previously used aluminium adjuvants. There is a need for rigorous evaluation of benefits and harms of the adjuvant AAHS.

02 Nov 2021·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Immunogenicity and safety of different schedules of the meningococcal ABCWY vaccine, with assessment of long-term antibody persistence and booster responses – results from two phase 2b randomized trials in adolescents

Q3 · MEDICINE

Article

Author: Kimmel, Murray ; Paassilta, Marita ; Jackowska, Teresa ; Vesikari, Timo ; Ahonen, Anitta ; Brzostek, Jerzy ; Pedotti, Paola ; Toneatto, Daniela ; Keshavan, Pavitra ; Bindi, Ilaria ; Szenborn, Leszek ; Clifford, Robert ; Virta, Miia ; Majda-Stanislawska, Ewa

The meningococcal serogroup B (MenB) protein vaccine, 4CMenB, combined with MenA, MenC, MenW and MenY polysaccharide-protein conjugates for a pentavalent MenABCWY vaccine, can potentially protect against most causative agents of invasive meningococcal disease worldwide. Two phase 2b, randomized, multicenter studies were conducted (NCT02212457, NCT02946385) to assess the immunogenicity and safety of the MenABCWY vaccine as well as antibody persistence and response to a booster dose 2 years after the last vaccination, compared to 4CMenB vaccination. Participants (10 - 18 years), randomized (3:3:2:2:2:2), received the 4-component 4CMenB vaccine according to a 0-2 month (M) schedule or MenABCWY according to a 0-2, 0-6, 0-2-6, 0-1, or 0-11 M schedule. All participants received 5 injections (at M0, M1, M2, M6 and M12) with either the study vaccines or placebo/hepatitis A vaccine. Follow-on participants (4CMenB-0-2, MenABCWY-0-2, MenABCWY-0-6 and MenABCWY-0-2-6 groups) received one dose of either 4CMenB (4CMenB-0-2 group) or MenABCWY and newly enrolled, age-matched, meningococcal vaccine-naïve adolescents (randomized 1:1) received 2 doses (0-2 M) of either 4CMenB or MenABCWY. MenABCWY vaccination was immunogenic against MenB test strains. Non-inferiority for all 4 components of the 4CMenB vaccine could not be demonstrated for the 0-2 M schedule. Antibodies persisted up to 2 years post-MenABCWY vaccination and a booster dose induced an anamnestic response as higher titers were observed in follow-on participants compared to the first-dose response in vaccine-naïve participants. MenABCWY had a clinically-acceptable safety profile, not different from that of 4CMenB.

100 Deals associated with Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)

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Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)

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